9 Senior Clinical Research Associate Pharmaceutical jobs in whatjobs
Senior Clinical Research Associate - Pharmaceutical
Posted 20 days ago
Job Viewed
Job Description
Our client, a fast-growing pharmaceutical company committed to developing life-changing medications, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their fully remote team. This position offers the flexibility to work from home while playing a critical role in the successful execution of clinical trials. The Senior CRA will be responsible for monitoring clinical trial sites to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
Key Responsibilities:
Qualifications:
This role, based conceptually in **Nyeri, Nyeri, KE**, is designed for a dedicated professional who thrives in a remote work environment and is passionate about advancing pharmaceutical research.
Key Responsibilities:
- Conduct pre-study, initiation, interim, and close-out monitoring visits to clinical trial sites.
- Ensure accurate, complete, and timely collection of clinical data.
- Verify the rights and well-being of trial subjects.
- Ensure that the trial is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), and regulatory requirements.
- Oversee site personnel to ensure they are properly trained and conduct the trial in accordance with the protocol.
- Resolve data queries and ensure timely data entry.
- Manage communication with investigators and site staff.
- Prepare and present monitoring visit reports.
- Identify site issues and develop corrective action plans.
- Maintain Trial Master File (TMF) documentation.
- Participate in the selection and qualification of new clinical trial sites.
- Contribute to the development and review of clinical trial protocols and other study documents.
- Ensure compliance with all applicable local and international regulations.
Qualifications:
- Bachelor's degree in a life science, nursing, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate.
- Thorough understanding of ICH-GCP guidelines and other relevant regulatory requirements.
- Proven experience in monitoring multiple clinical trials across various therapeutic areas.
- Excellent organizational skills and attention to detail.
- Strong communication, interpersonal, and negotiation skills.
- Ability to work independently and manage time effectively in a remote setting.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Willingness to travel occasionally for essential meetings or site visits, if required, though the role is predominantly remote.
This role, based conceptually in **Nyeri, Nyeri, KE**, is designed for a dedicated professional who thrives in a remote work environment and is passionate about advancing pharmaceutical research.
This advertiser has chosen not to accept applicants from your region.
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Senior Clinical Research Associate - Pharmaceutical
Posted 22 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) for a fully remote position. This critical role involves overseeing and managing all aspects of clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. As a Senior CRA, you will be responsible for site selection, initiation, monitoring, and close-out activities, working collaboratively with investigators, study coordinators, and internal project teams. You will play a vital role in ensuring the integrity and quality of clinical data, contributing to the successful development of new pharmaceutical products. The ideal candidate possesses strong analytical skills, meticulous attention to detail, and excellent communication abilities, thriving in an independent, remote work environment.
Responsibilities:
Qualifications:
Responsibilities:
- Conduct pre-study, initiation, routine monitoring, and close-out visits for clinical trial sites.
- Ensure compliance with study protocols, GCP, FDA regulations, and other applicable guidelines.
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Manage communication and relationships with investigators, site staff, and study sponsors.
- Identify and report adverse events and serious adverse events according to protocol.
- Oversee site recruitment efforts and patient enrollment progress.
- Ensure sites maintain adequate investigational product accountability.
- Prepare and present site monitoring reports and action plans.
- Train and mentor junior CRAs and site personnel.
- Contribute to the development and review of study-related documents, such as protocols and Case Report Forms (CRFs).
- Participate in site audits and regulatory inspections.
Qualifications:
- Bachelor's degree in a life science, nursing, or a related healthcare field. Advanced degree preferred.
- Minimum of 5 years of progressive experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Proven experience in monitoring multiple clinical trial sites.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong data verification and analytical skills.
- Exceptional written and verbal communication skills.
- Ability to work independently and manage time effectively in a remote setting.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Relevant certifications (e.g., ACRP, SOCRA) are highly desirable.
This advertiser has chosen not to accept applicants from your region.
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Senior Clinical Research Associate (Pharmaceutical)
Posted 14 days ago
Job Viewed
Job Description
Our client, a prestigious pharmaceutical company dedicated to advancing healthcare, is actively seeking a highly experienced Senior Clinical Research Associate (CRA) to join their fully remote clinical operations team. This critical role is responsible for the meticulous oversight and management of clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The ideal candidate will possess a deep understanding of clinical trial processes, site management, data integrity, and patient safety. You will be the primary liaison between the sponsor and investigative sites, conducting site visits, monitoring trial progress, and resolving any issues that may arise. Responsibilities include site selection and initiation, ongoing monitoring of study conduct, data review, and ensuring timely reporting of adverse events. A significant part of this role involves building strong, collaborative relationships with investigators, site staff, and internal study teams. As this is a fully remote position, exceptional communication, organizational skills, and self-discipline are paramount. You must be adept at managing your workload independently, traveling occasionally to sites as needed (though the role is remote-based), and effectively communicating complex trial information. We are looking for a dedicated and detail-oriented CRA with a passion for contributing to the development of life-changing medicines, working from the convenience of their home office. Your commitment to quality and patient well-being will be essential in driving successful clinical research outcomes.
Responsibilities:
Responsibilities:
- Manage and oversee the conduct of clinical trials at assigned investigative sites, ensuring compliance with protocols, SOPs, and GCP guidelines.
- Perform site selection, initiation, monitoring, and close-out visits.
- Ensure the accuracy, completeness, and timeliness of clinical data by reviewing source documents and case report forms (CRFs).
- Verify patient safety and the rights of study participants throughout the trial.
- Train and support site staff on study procedures, protocol requirements, and regulatory guidelines.
- Serve as the primary point of contact for investigators and site personnel.
- Report and escalate study-related issues, including protocol deviations and adverse events, to the appropriate parties.
- Ensure the proper storage and accountability of study supplies and investigational product.
- Collaborate effectively with internal teams, including project managers, data managers, and medical monitors.
- Contribute to the development of study-related documents, such as protocols, informed consent forms, and monitoring plans.
- Participate in study team meetings and provide updates on site performance and trial progress.
- Stay current with clinical research regulations, industry trends, and best practices.
- Maintain all necessary documentation and records for assigned studies.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree or equivalent is a plus.
- Minimum of 6 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry.
- Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trial sites and ensuring data integrity.
- Excellent knowledge of clinical trial processes from study start-up to close-out.
- Strong therapeutic area expertise is desirable.
- Exceptional interpersonal, communication, and negotiation skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Demonstrated ability to work independently, manage multiple priorities, and meet deadlines in a remote environment.
- Willingness to travel to investigative sites as required (percentage of travel may vary).
- A strong commitment to ethical research conduct and patient safety.
This advertiser has chosen not to accept applicants from your region.
2
Senior Clinical Research Associate - Pharmaceutical
Posted 13 days ago
Job Viewed
Job Description
Our client, a dynamic pharmaceutical company, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their expanding team. This is a critical, fully remote role responsible for overseeing and managing clinical trials to ensure compliance with study protocols, regulatory requirements, and ethical standards. You will be instrumental in monitoring trial sites, ensuring data integrity, and working collaboratively with investigators, study coordinators, and internal teams to achieve successful trial outcomes. The ideal candidate possesses a strong background in clinical research, meticulous attention to detail, and the ability to excel in an independent, remote work environment.
Responsibilities:
Responsibilities:
- Monitor clinical trial sites to ensure adherence to Good Clinical Practice (GCP), protocol requirements, and all applicable regulations.
- Perform site initiation visits, interim monitoring visits, and close-out visits.
- Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
- Identify and report adverse events and protocol deviations in a timely manner.
- Train and support site staff on study procedures, data collection, and regulatory requirements.
- Build and maintain strong relationships with principal investigators and site staff.
- Ensure investigational product accountability and proper handling at trial sites.
- Prepare monitoring visit reports and communicate findings and action items to study teams and management.
- Participate in the selection and qualification of new clinical trial sites.
- Stay updated on relevant therapeutic areas, clinical trial methodologies, and regulatory guidelines.
- Bachelor's degree in a life science, nursing, pharmacy, or a related healthcare field. A Master's degree is a plus.
- 5+ years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
- Extensive knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in monitoring multi-center clinical trials across various phases.
- Excellent understanding of clinical trial documentation and data management processes.
- Strong analytical and problem-solving skills.
- Exceptional organizational skills and meticulous attention to detail.
- Excellent written and verbal communication skills.
- Ability to work independently, manage time effectively, and travel as needed (though the role is remote, occasional site visits may be required).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
This advertiser has chosen not to accept applicants from your region.
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Senior Clinical Research Associate - Pharmaceutical
Posted 13 days ago
Job Viewed
Job Description
Our client is a leading pharmaceutical company seeking an experienced Senior Clinical Research Associate (CRA) to join their team in Kakamega, Kakamega, KE . This is a field-based role that requires extensive travel to study sites. The Senior CRA will be responsible for monitoring clinical trials to ensure adherence to protocols, regulations, and Good Clinical Practice (GCP) guidelines. You will play a critical role in data integrity, patient safety, and the successful execution of clinical studies, contributing to the development of life-saving medications.
Key Responsibilities:
Key Responsibilities:
- Conduct pre-study, initiation, monitoring, and close-out visits at clinical trial sites.
- Ensure protocol adherence and compliance with all applicable regulations (FDA, ICH, GCP).
- Verify the accuracy and completeness of source documents and case report forms (CRFs).
- Train and support site staff on study procedures, protocol requirements, and data collection.
- Identify and report adverse events (AEs) and serious adverse events (SAEs) according to protocol.
- Manage site issues and escalations, ensuring timely resolution.
- Build and maintain strong relationships with investigators, site staff, and study sponsors.
- Perform site audits to ensure data quality and regulatory compliance.
- Contribute to the development and review of study-related documents, such as protocols, informed consent forms, and monitoring plans.
- Manage study supplies and investigational product at sites as needed.
- Prepare detailed monitoring visit reports and follow-up actions.
- Stay current with industry trends, regulatory changes, and best practices in clinical research.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 5 years of experience as a Clinical Research Associate, with a proven track record of monitoring clinical trials.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience in managing multiple clinical studies and sites simultaneously.
- Strong understanding of clinical trial processes and documentation.
- Excellent communication, interpersonal, and negotiation skills.
- Ability to travel extensively (up to 70%) within the assigned region.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong organizational skills and attention to detail.
- Ability to work independently and manage time effectively.
- Experience in a specific therapeutic area is a plus.
This advertiser has chosen not to accept applicants from your region.
4
Senior Clinical Research Associate (Pharmaceutical)
Posted 17 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company, is looking for a highly experienced Senior Clinical Research Associate (CRA) to join their dynamic clinical operations team. This is an on-site role focused on the meticulous execution of clinical trials. You will be responsible for monitoring clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The ideal candidate will have a strong understanding of clinical trial processes, from site selection and initiation to monitoring, close-out, and data management. Your duties will include conducting pre-study, initiation, interim monitoring, and close-out visits. You will verify the accuracy and completeness of study data, ensure proper drug accountability, and serve as the primary point of contact for investigators and site staff. The ability to build strong relationships with investigators and site personnel, foster compliance, and troubleshoot site-specific issues is essential. You must be proficient in reviewing and analyzing clinical data, identifying data discrepancies, and ensuring timely resolution. Excellent communication, organizational, and time management skills are paramount, along with the ability to travel regularly to assigned clinical trial sites. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is required. This role offers the opportunity to contribute to the development of life-saving therapies and advance your career within a leading pharmaceutical organization. You will be actively involved in clinical trial activities conducted within the **Mlolongo, Machakos, KE** region and potentially beyond.
Responsibilities:
Responsibilities:
- Monitor clinical trial sites according to study protocols and GCP.
- Conduct pre-study, initiation, monitoring, and close-out visits.
- Verify clinical trial data accuracy and completeness.
- Ensure compliance with regulatory requirements and study guidelines.
- Act as the primary liaison between study sites and the sponsor.
- Manage drug accountability and regulatory documentation at sites.
- Identify and resolve site-specific issues and data discrepancies.
- Train and mentor site staff on study procedures.
- Prepare and submit monitoring visit reports.
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 5 years of experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience with EDC and CTMS systems.
- Strong monitoring, auditing, and problem-solving skills.
- Excellent communication, interpersonal, and organizational abilities.
- Willingness to travel frequently.
This advertiser has chosen not to accept applicants from your region.
5
Senior Clinical Research Associate - Pharmaceutical
Posted 8 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company committed to advancing healthcare through innovative research, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their fully remote team. This role is essential for the successful execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. As a Senior CRA, you will be responsible for monitoring clinical trial sites, managing data integrity, and collaborating with investigators and study teams to ensure patient safety and data accuracy. This position offers the flexibility of remote work, allowing you to contribute to life-saving research from the convenience of your home office. The ideal candidate will possess a strong background in clinical research, excellent therapeutic area knowledge, and exceptional organizational and communication skills. Experience within the Kenyan healthcare landscape is advantageous. Join a team dedicated to bringing groundbreaking therapies to patients worldwide.
Key Responsibilities:
Key Responsibilities:
- Conduct pre-study, initiation, routine, and close-out monitoring visits for clinical trial sites according to Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Ensure accurate, complete, and timely collection of clinical data from study sites.
- Verify the source data and documents at the sites to ensure their accuracy and completeness, and confirm compliance with the protocol.
- Train and support site staff on study protocols, procedures, and regulatory requirements.
- Act as the primary point of contact between the sponsor and the investigational sites.
- Identify, assess, and resolve site-level issues and deviations, escalating when necessary.
- Ensure compliance with all applicable local and international regulations, including GCP, ICH guidelines, and FDA/EMA requirements.
- Manage investigational product accountability at the sites.
- Review and ensure the completeness of regulatory binders at each site.
- Contribute to the development of study-related documents, such as protocols, informed consent forms, and Case Report Forms (CRFs).
- Prepare monitoring visit reports and ensure timely follow-up on action items.
- Communicate effectively with internal study teams, including project managers, medical monitors, and data management personnel.
- Mentor junior CRAs and contribute to the training of new team members.
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or a related healthcare field.
- Minimum of 5-7 years of experience as a Clinical Research Associate, with a significant portion involving direct site monitoring.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in therapeutic areas such as oncology, cardiology, or infectious diseases is highly preferred.
- Excellent understanding of clinical trial processes, from study start-up to close-out.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Exceptional written and verbal communication skills, with the ability to build rapport and influence stakeholders.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently, manage time effectively, and prioritize tasks in a remote environment.
- Willingness to travel occasionally as required, though the role is primarily remote.
- Familiarity with the healthcare system in Kericho, Kericho, KE and surrounding regions is a plus.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Clinical Research Associate - Pharmaceutical
Posted 7 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical entity, is looking for a highly skilled and experienced Senior Clinical Research Associate (CRA) to join their expanding research team. This position is fully remote, allowing you to conduct your vital work from anywhere, contributing to groundbreaking pharmaceutical development. As a Senior CRA, you will be instrumental in ensuring the quality, integrity, and timely completion of clinical trials in compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and protocol specifications. You will be responsible for site selection, initiation, monitoring, and close-out activities for multiple clinical trial sites. This role requires meticulous attention to detail, excellent communication skills, and a deep understanding of clinical research methodologies.
Key Responsibilities:
Key Responsibilities:
- Perform site selection, initiation, routine monitoring, and close-out visits according to approved monitoring plans.
- Ensure accurate, complete, and timely entry of data into clinical databases.
- Verify the quality and integrity of data collected, and ensure source data are accurate and complete.
- Manage and resolve data discrepancies and issues identified during monitoring visits.
- Maintain ongoing communication with study sites to ensure protocol adherence and patient safety.
- Train and mentor site staff on study-related procedures, regulatory requirements, and data collection.
- Prepare monitoring visit reports and follow-up on action items with sites and study teams.
- Ensure compliance with all applicable regulatory requirements and company SOPs.
- Act as a liaison between the clinical operations team, investigators, and other study stakeholders.
- Contribute to the development and review of clinical trial protocols, case report forms (CRFs), and other study documents.
- Identify potential risks and issues at study sites and implement corrective and preventive actions.
- Manage and track study supplies and investigational product at clinical sites.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
- Minimum of 5-8 years of progressive experience as a Clinical Research Associate.
- Extensive knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in site monitoring, data management, and regulatory compliance.
- Excellent verbal and written communication skills.
- Strong organizational and time management abilities.
- Ability to travel to sites as needed (though this is a remote role, occasional site visits might be required post-pandemic or for specific critical phases).
- Proficiency with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Demonstrated ability to work independently and as part of a remote team.
- Critical thinking and problem-solving skills.
This advertiser has chosen not to accept applicants from your region.
7
Senior Clinical Research Associate (Pharmaceutical)
Posted today
Job Viewed
Job Description
Our client, a dynamic pharmaceutical company, is looking for an experienced Senior Clinical Research Associate (CRA) to join their dedicated clinical operations team. This role operates on a fully remote basis, offering the flexibility to manage clinical trials and contribute to groundbreaking drug development from anywhere. You will be responsible for the monitoring and management of clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. This position requires meticulous attention to detail, strong organizational skills, and the ability to build effective relationships with site personnel. Key responsibilities include conducting pre-study, initiation, interim, and close-out visits; identifying, evaluating, and training potential investigators; and ensuring accurate and timely collection of study data. You will also be involved in resolving site issues, reporting adverse events, and ensuring site compliance with safety reporting procedures. The ideal candidate will possess a Bachelor's degree in a life science or related field, with a minimum of 5 years of experience as a Clinical Research Associate, preferably within the pharmaceutical industry. A thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA, EMA), and GCP is essential. Strong communication, interpersonal, and problem-solving skills are crucial for effectively managing sites and collaborating with internal teams in a remote environment. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is highly desirable. This is an excellent opportunity to contribute to the advancement of new therapies and build a successful career in clinical research within a supportive and innovative organization, with potential responsibilities for studies impacting the region of Bungoma, Bungoma, KE .
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