957 Clinical Research Associate Cra jobs in Kenya
Clinical Research Associate (CRA)
Posted 20 days ago
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Lead Clinical Research Associate (CRA)
Posted 22 days ago
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Remote Clinical Research Associate (CRA)
Posted 21 days ago
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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.
Senior Clinical Research Associate (CRA)
Posted 22 days ago
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Clinical Research Associate (CRA) - Pharmaceutical
Posted 8 days ago
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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.
Remote Senior Clinical Research Associate (CRA)
Posted 19 days ago
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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.
Senior Clinical Research Associate (CRA) - Remote
Posted 13 days ago
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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.
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Clinical Research Associate (CRA) - Pharmaceutical - Remote
Posted 4 days ago
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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.
Clinical Research Associate (CRA) - Remote
Posted 16 days ago
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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.
Senior Clinical Research Associate (CRA) - Pharmaceutical Trials
Posted 22 days ago
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Responsibilities:
- Conduct pre-study, initiation, interim, and close-out monitoring visits for clinical trial sites.
- Verify the accuracy, completeness, and validity of study data through source data verification (SDV).
- Ensure compliance with study protocols, FDA regulations, GCP, and other applicable guidelines.
- Train and support investigators and site staff on study procedures, regulatory requirements, and data collection.
- Manage site recruitment, enrollment, and retention efforts to meet study timelines.
- Oversee the proper storage and accountability of investigational products and study supplies.
- Identify, track, and resolve site-level issues and deviations, implementing corrective and preventive actions (CAPAs).
- Prepare monitoring visit reports and follow-up letters in a timely and accurate manner.
- Maintain effective communication with study teams, investigators, and sponsors regarding site progress and any emerging issues.
- Ensure all required regulatory documents are accurate, complete, and maintained at the site.
- Participate in investigator meetings and training sessions as required.
- Contribute to the development and review of study-related documents, such as protocols and case report forms (CRFs).
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field; advanced degree preferred.
- Minimum of 5 years of progressive experience as a Clinical Research Associate, with a focus on monitoring and site management.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in therapeutic areas relevant to pharmaceutical research.
- Excellent understanding of clinical trial processes and documentation.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Exceptional written and verbal communication and interpersonal skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to manage multiple studies and sites simultaneously and work independently in a remote environment.
- Willingness to travel occasionally to sites as needed, though the role is primarily remote.
- This role is based in Mlolongo, Machakos, KE but is conducted entirely remotely.
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