691 Senior Cra Positions jobs in Kenya
Job Description
CRA II/Sr CRA/Senior CRA/Clinical Research Associate - Home-based, Kenya
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking experienced Clinical Research Associates (CRA II/Sr CRA) to join our diverse and dynamic team. As a Senior CRA/CRA II at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
**What You Will Be Doing:**
+ Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
+ Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
+ Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
+ Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
+ Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
**Your Profile:**
+ Advanced degree in a relevant field such as life sciences, nursing, or medicine.
+ Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
+ Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
+ Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
+ Excellent communication skills in English and local language, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
#LI-JS1
#LI-TK1
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking experienced Clinical Research Associates (CRA II/Sr CRA) to join our diverse and dynamic team. As a Senior CRA/CRA II at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
**What You Will Be Doing:**
+ Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
+ Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
+ Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
+ Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
+ Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
**Your Profile:**
+ Advanced degree in a relevant field such as life sciences, nursing, or medicine.
+ Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
+ Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
+ Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
+ Excellent communication skills in English and local language, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
#LI-JS1
#LI-TK1
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
This advertiser has chosen not to accept applicants from your region.
0
Clinical Research Associate (CRA)
Posted 20 days ago
Job Viewed
Job Description
Our client, a cutting-edge pharmaceutical company, is seeking a diligent and experienced Clinical Research Associate (CRA) to join their team. This role involves significant remote work with occasional travel required to clinical sites. As a CRA, you will play a crucial role in ensuring the smooth execution of clinical trials, upholding the highest standards of data integrity and patient safety. Your primary responsibilities will include monitoring clinical trial sites, verifying data accuracy, ensuring adherence to protocols and regulatory requirements (e.g., GCP, FDA), and managing site staff. You will conduct pre-study, initiation, interim, and close-out visits, providing essential support to investigators and study coordinators. The ideal candidate possesses a Bachelor's degree in a life science, nursing, or a related field; a Master's degree or higher is advantageous. A minimum of 3 years of experience as a CRA in the pharmaceutical or biotech industry is required, with a proven track record of successful trial management. Strong knowledge of clinical trial processes, regulatory guidelines, and medical terminology is essential. Excellent organizational, time management, and communication skills are critical for managing multiple sites and collaborating effectively with cross-functional teams, both in person and remotely. The ability to travel occasionally to designated clinical trial sites is a requirement for this hybrid role. Our client is committed to advancing medical treatments and offers a stimulating work environment with opportunities for professional growth. Join a dedicated team focused on bringing life-changing therapies to patients.
This advertiser has chosen not to accept applicants from your region.
1
Lead Clinical Research Associate (CRA)
Posted 22 days ago
Job Viewed
Job Description
Our client, a pioneering pharmaceutical firm, is actively searching for an experienced and dedicated Lead Clinical Research Associate (CRA) to join their expanding research team. This is a fully remote position, enabling you to contribute to groundbreaking drug development from the comfort of your home. As a Lead CRA, you will play a pivotal role in overseeing and managing clinical trial activities, ensuring compliance with regulatory standards, and driving the successful execution of studies. Your responsibilities will include coordinating and monitoring clinical trial sites, performing site visits (pre-study, initiation, routine monitoring, and close-out), ensuring data integrity and accuracy, and verifying adherence to protocols and Good Clinical Practice (GCP) guidelines. You will also be responsible for mentoring and training junior CRAs, serving as a key point of contact for investigators and site staff, and resolving site-level issues promptly. This role demands a deep understanding of pharmaceutical research, regulatory affairs, and clinical trial management. The ideal candidate will possess exceptional organizational, communication, and interpersonal skills, with a proven ability to manage multiple tasks and priorities effectively. Experience in therapeutic areas such as oncology, cardiology, or infectious diseases is highly valued. A strong track record of successful site management and a commitment to quality and patient safety are essential. You will work collaboratively with internal teams, including data management, biostatistics, and regulatory affairs, to ensure seamless trial progression. This remote role requires self-discipline, proactivity, and a results-driven approach. A Bachelor's degree in life sciences, nursing, or a related field is mandatory. Advanced degrees or relevant certifications (e.g., ACRP, SoCRA) are a plus. This is an exceptional opportunity to advance your career in clinical research within a supportive and innovative environment. Be part of a team that is committed to improving global health through cutting-edge pharmaceutical development. Your expertise will directly contribute to bringing life-changing therapies to patients worldwide. Embrace a flexible work model that prioritizes outcomes and professional growth.
This advertiser has chosen not to accept applicants from your region.
2
Remote Clinical Research Associate (CRA)
Posted 21 days ago
Job Viewed
Job Description
Our client is actively seeking a highly qualified and motivated Remote Clinical Research Associate (CRA) to join their global clinical operations team. This role is fully remote, allowing you to manage clinical trial sites and ensure data integrity from your home office. As a Remote CRA, you will be responsible for monitoring investigational sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. You will conduct pre-study visits, site initiation visits, routine monitoring visits (remote or on-site as needed), and close-out visits. Your key focus will be on data accuracy, patient safety, and the ethical conduct of clinical trials. The ideal candidate will possess a strong understanding of pharmaceutical research processes, excellent organizational skills, and the ability to build strong relationships with site staff. You must be adept at utilizing electronic data capture (EDC) systems and other clinical trial management software. This position demands excellent communication, analytical, and problem-solving skills, along with the ability to work independently and travel periodically when necessary.
Key Responsibilities:
Key Responsibilities:
- Monitor investigational clinical trial sites according to protocol and regulatory requirements.
- Conduct site visits, including pre-study, initiation, monitoring, and close-out visits.
- Ensure adherence to GCP, FDA regulations, and study-specific protocols.
- Verify the accuracy, completeness, and integrity of clinical data through source document verification (SDV).
- Oversee patient safety and report adverse events promptly.
- Build and maintain strong working relationships with Principal Investigators and site staff.
- Provide training and ongoing support to study site personnel.
- Manage site supplies and investigational product accountability.
- Review and resolve data queries in the EDC system.
- Prepare and submit monitoring visit reports in a timely manner.
- Identify site issues and implement corrective and preventative actions (CAPAs).
- Ensure regulatory compliance and maintain essential study documents.
- Contribute to protocol development and study design where applicable.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA).
- Demonstrated experience in monitoring clinical trials across various therapeutic areas.
- Thorough understanding of GCP, ICH guidelines, and regulatory requirements.
- Proficiency with EDC systems and clinical trial management software.
- Excellent verbal and written communication skills.
- Strong organizational, time management, and problem-solving abilities.
- Ability to work independently and manage multiple sites/projects in a remote environment.
- Willingness to travel nationally or internationally as required for site visits.
- Attention to detail and commitment to data accuracy and patient safety.
This advertiser has chosen not to accept applicants from your region.
3
Senior Clinical Research Associate (CRA)
Posted 22 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company, is seeking an experienced Senior Clinical Research Associate (CRA) to join their clinical operations team. This role is based in Nakuru and requires the candidate to be present at specific research sites. You will be responsible for monitoring clinical trials to ensure they are conducted, recorded, and reported in accordance with the study protocol, company policies, and all applicable regulatory requirements. Your duties will include site selection, initiation, monitoring, and close-out visits; ensuring the quality and integrity of data collected; managing investigational product accountability; and serving as the primary liaison between the sponsor and the clinical sites. The ideal candidate will have a Bachelor's degree in a life science or related field, a minimum of 5 years of experience as a CRA, and a thorough understanding of ICH-GCP guidelines and regulatory requirements. Strong communication, organizational, and problem-solving skills are essential. You must be proficient in medical terminology and possess excellent attention to detail. While this role is not remote, it offers the opportunity to work on cutting-edge clinical research and contribute to the development of life-changing therapies. Travel to clinical trial sites within the region will be required. We are looking for a dedicated professional who is passionate about advancing medical science and ensuring patient safety. Your commitment to upholding the highest standards of clinical research conduct will be critical. Join a leading pharmaceutical organization and play a vital role in bringing innovative treatments to market. This is an excellent opportunity for a motivated CRA to further their career in a challenging and rewarding environment. You will have the chance to build strong relationships with investigators and site staff, fostering a collaborative approach to clinical research.
This advertiser has chosen not to accept applicants from your region.
4
Clinical Research Associate (CRA) - Pharmaceutical
Posted 8 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly motivated and experienced Clinical Research Associate (CRA) for a fully remote position. This critical role will involve overseeing and managing clinical trials to ensure they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and applicable regulations. You will be responsible for site selection, initiation, monitoring, and close-out visits, ensuring data integrity and patient safety. This remote position offers significant flexibility while maintaining vital oversight of research sites.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Conduct site selection and feasibility assessments for potential clinical trial sites.
- Initiate clinical trial sites, ensuring all necessary documentation is in place and staff are adequately trained.
- Monitor clinical trial sites regularly (remotely and on-site as needed) to verify compliance with protocol, SOPs, and Good Clinical Practice (GCP) guidelines.
- Ensure the accuracy, completeness, and integrity of clinical data collected at trial sites.
- Manage communication with investigators, study coordinators, and site staff.
- Resolve data queries and ensure timely resolution of issues identified during monitoring visits.
- Oversee patient recruitment and retention efforts at assigned sites.
- Manage investigational product accountability and drug supplies at sites.
- Prepare monitoring reports and document all site activities thoroughly.
- Ensure all regulatory requirements and ethical guidelines are followed.
- Participate in study team meetings and contribute to the overall success of the clinical trial.
- Maintain a strong understanding of therapeutic areas and study protocols.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field. Advanced degree is a plus.
- Minimum of 5 years of experience as a Clinical Research Associate, with a strong understanding of GCP, ICH guidelines, and regulatory requirements.
- Proven experience in monitoring clinical trials across various phases and therapeutic areas.
- Excellent understanding of clinical trial processes, from initiation to close-out.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Exceptional organizational and time management skills, with the ability to manage multiple priorities effectively in a remote setting.
- Outstanding written and verbal communication and interpersonal skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical sites as required (though the role is predominantly remote).
- Self-motivated, proactive, and able to work independently with minimal supervision.
- Commitment to patient safety and data integrity.
This advertiser has chosen not to accept applicants from your region.
5
Remote Senior Clinical Research Associate (CRA)
Posted 19 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical research organization, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their fully remote global clinical operations team. In this critical role, you will be responsible for monitoring clinical trials to ensure adherence to protocols, regulatory requirements, and data integrity. The ideal candidate will possess extensive experience in site management, patient safety, and regulatory compliance within the pharmaceutical industry. You will work independently, managing multiple sites remotely, and ensuring the successful execution of clinical studies.
Key Responsibilities:
Qualifications:
This is an outstanding opportunity to contribute to groundbreaking pharmaceutical research while enjoying the flexibility of a fully remote role. Our client offers a competitive salary, comprehensive benefits, and a supportive environment for professional growth within a global organization committed to remote work excellence.
Key Responsibilities:
- Conduct remote and on-site (as needed, but primarily remote oversight) monitoring visits to assess study conduct and data quality.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
- Verify the accuracy and completeness of clinical trial data, source documents, and patient records.
- Manage relationships with clinical investigators and site staff, providing training and support.
- Oversee study start-up activities, including site selection, initiation, and regulatory documentation.
- Track study progress, identify risks and issues, and implement corrective and preventative actions (CAPAs).
- Prepare monitoring reports, study updates, and other essential documentation.
- Contribute to the development and refinement of clinical trial protocols and associated documents.
- Ensure timely resolution of data discrepancies and queries.
- Maintain accurate and up-to-date trial master file (TMF) documentation.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree is a plus.
- Minimum of 5 years of experience as a Clinical Research Associate, with a strong emphasis on remote monitoring and site management.
- In-depth knowledge of GCP, ICH guidelines, FDA regulations, and other relevant regulatory requirements.
- Proven ability to manage multiple clinical trials and sites simultaneously from a remote capacity.
- Excellent understanding of clinical trial processes, drug development, and medical terminology.
- Strong skills in data analysis, critical thinking, and problem-solving.
- Exceptional communication, interpersonal, and organizational skills.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to work autonomously, manage time effectively, and meet strict deadlines in a remote setting.
- Willingness to travel for occasional essential on-site visits, as required.
This is an outstanding opportunity to contribute to groundbreaking pharmaceutical research while enjoying the flexibility of a fully remote role. Our client offers a competitive salary, comprehensive benefits, and a supportive environment for professional growth within a global organization committed to remote work excellence.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Clinical Research Associate (CRA) - Remote
Posted 13 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company committed to advancing global health, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their entirely remote clinical operations team. This role offers the flexibility to manage clinical trials from anywhere, contributing to the development of life-changing medicines. You will be responsible for monitoring clinical trial sites to ensure adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The ideal candidate possesses extensive experience in clinical trial monitoring, strong knowledge of regulatory affairs, and exceptional organizational skills. You will build and maintain strong relationships with investigators and site staff, providing training and support to ensure data integrity and patient safety. We are looking for an individual with exceptional attention to detail, excellent problem-solving abilities, and superior communication and interpersonal skills, capable of thriving in an independent remote work environment. Responsibilities include conducting pre-study, initiation, interim monitoring, and close-out visits, as well as verifying data accuracy and completeness. You will also be involved in resolving site issues, ensuring timely subject recruitment, and preparing monitoring reports. The ability to manage your own schedule, travel as needed (within reasonable parameters for remote roles), and effectively advocate for patient safety and data quality is crucial. This is an exceptional opportunity to contribute to groundbreaking pharmaceutical research while enjoying the autonomy of a remote position. You will be an integral part of a dedicated team focused on bringing innovative therapies to patients worldwide. Our client is committed to professional development and offers a supportive environment for career growth within the pharmaceutical industry.
Responsibilities:
Responsibilities:
- Monitor clinical trial sites to ensure compliance with study protocols, SOPs, GCP, and regulatory requirements.
- Conduct pre-study, initiation, routine monitoring, and close-out visits according to monitoring plan.
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Identify, resolve, and escalate site-related issues in a timely manner.
- Build and maintain positive relationships with investigators, site staff, and study teams.
- Provide training and ongoing support to clinical trial site personnel.
- Ensure subject safety and data privacy are maintained throughout the study.
- Prepare and submit comprehensive monitoring reports and follow-up on action items.
- Participate in study team meetings and contribute to study planning and execution.
- Manage a portfolio of clinical trial sites and ensure timely completion of monitoring activities.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
- Minimum of 5 years of progressive experience as a Clinical Research Associate (CRA) or equivalent role.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in monitoring Phase I-IV clinical trials across various therapeutic areas.
- Exceptional understanding of clinical trial processes and documentation.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to effectively communicate with diverse stakeholders.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel as required for site visits (typically up to 40-60%, depending on study needs).
- Demonstrated ability to work independently, manage time effectively, and prioritize tasks in a remote setting.
This advertiser has chosen not to accept applicants from your region.
7
Clinical Research Associate (CRA) - Pharmaceutical - Remote
Posted 4 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical innovator, is seeking a highly competent and experienced Clinical Research Associate (CRA) to join their expanding research and development team. This is a fully remote position, offering the flexibility to conduct site monitoring and essential study-related activities from anywhere. The successful candidate will play a critical role in ensuring the quality, integrity, and compliance of clinical trials, adhering to strict protocols and regulatory standards. You will be responsible for site management, data verification, and fostering strong relationships with investigators and site staff.
Responsibilities:
Responsibilities:
- Conduct pre-study, initiation, routine, and close-out visits to clinical trial sites according to study protocols and regulatory requirements.
- Monitor study conduct to ensure compliance with Good Clinical Practice (GCP), relevant regulations, and study-specific procedures.
- Verify the accuracy, completeness, and validity of clinical trial data by reviewing source documents and case report forms (CRFs).
- Ensure timely resolution of data queries and discrepancies in collaboration with site staff and data management teams.
- Manage communication and relationships with investigators and site personnel, providing training and support as needed.
- Oversee drug accountability and ensure proper storage and handling of investigational products at study sites.
- Prepare and submit comprehensive monitoring visit reports in a timely manner.
- Identify and report any deviations from study protocols, regulatory requirements, or standard operating procedures.
- Track site progress and ensure timely patient recruitment and retention.
- Assist in the selection and qualification of new clinical trial sites.
- Stay up-to-date with relevant therapeutic areas, protocols, and regulatory guidelines.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- Minimum of 4 years of experience as a Clinical Research Associate, preferably in a pharmaceutical or contract research organization (CRO) setting.
- Thorough understanding of clinical trial processes, GCP guidelines, and regulatory requirements (e.g., FDA, EMA).
- Proven ability to effectively monitor clinical trial sites and manage relationships with investigators and site staff.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to document findings clearly and concisely.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently, manage travel (if applicable, though this is remote), and prioritize tasks effectively in a remote environment.
- Attention to detail and commitment to data integrity and patient safety.
- Flexibility and adaptability to changing project needs and priorities.
This advertiser has chosen not to accept applicants from your region.
8
Clinical Research Associate (CRA) - Remote
Posted 16 days ago
Job Viewed
Job Description
Our client, a prominent player in the pharmaceutical industry, is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their innovative team. This role offers a hybrid work arrangement, providing a blend of remote flexibility and essential on-site engagement. The CRA is responsible for monitoring clinical trial sites to ensure data accuracy, patient safety, and adherence to protocols and regulatory requirements. You will act as the primary liaison between the investigative sites and the sponsor, overseeing all aspects of clinical trial conduct. This includes site selection, initiation, monitoring, and close-out visits. The ideal candidate will possess a strong understanding of Good Clinical Practice (GCP) guidelines and relevant regulatory frameworks. Your ability to meticulously review source documents, query data discrepancies, and ensure timely resolution is crucial. This position demands excellent organizational skills, attention to detail, and the ability to manage multiple priorities effectively. You will contribute significantly to the successful execution of clinical studies, ultimately aiding in the development of life-saving therapies. This role requires travel to clinical sites as needed, in addition to remote work responsibilities. The opportunity to work on diverse therapeutic areas and contribute to groundbreaking research makes this a compelling career move for aspiring CRAs.
Responsibilities:
Responsibilities:
- Perform site selection, initiation, monitoring, and close-out visits in accordance with clinical trial protocols and GCP.
- Ensure adherence to protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines at assigned clinical sites.
- Verify the accuracy, completeness, and integrity of clinical trial data through source data verification.
- Manage investigational product accountability and ensure proper storage and handling.
- Serve as the primary point of contact for investigators and site staff, providing training and support.
- Document all site activities and communications accurately and promptly in monitoring reports.
- Identify and escalate potential issues, risks, and protocol deviations to the study team.
- Assist with regulatory document preparation and submissions.
- Contribute to the development and review of clinical trial protocols and study-related documents.
- Ensure timely enrollment and completion of study procedures at assigned sites.
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 3 years of experience as a Clinical Research Associate.
- Strong knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Experience in conducting remote and on-site monitoring visits.
- Excellent verbal and written communication skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong organizational and time management skills.
- Ability to travel to clinical trial sites as required.
- Detail-oriented with strong analytical and problem-solving abilities.
- Experience in (specific therapeutic area) is highly desirable.
This advertiser has chosen not to accept applicants from your region.
9