9 Clinical Research Associate Pharmaceutical jobs in whatjobs
Clinical Research Associate - Pharmaceutical
Posted 22 days ago
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Job Description
Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits in accordance with GCP and protocol requirements.
- Monitor study conduct to ensure compliance with protocol, SOPs, regulatory requirements, and ethical principles.
- Verify the accuracy, completeness, and integrity of clinical data collected at study sites through source data verification.
- Ensure subject safety and well-being, reporting any adverse events or protocol deviations promptly.
- Train and support site staff, providing guidance on study procedures and regulatory requirements.
- Manage relationships with investigators and site personnel, fostering effective collaboration.
- Review and ensure accurate and timely submission of study-related documents.
- Oversee drug accountability and ensure proper storage and dispensing of investigational products.
- Prepare and present monitoring visit reports, addressing any identified issues and action items.
- Ensure the timely retrieval of essential study documents from study sites.
- Participate in study team meetings and contribute to study planning and execution.
- Maintain up-to-date knowledge of therapeutic areas, drug development processes, and relevant regulations.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry.
- In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA).
- Proven experience in monitoring clinical trials across various phases.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong attention to detail and accuracy in data management and reporting.
- Excellent organizational, communication, and interpersonal skills.
- Ability to travel frequently to study sites (up to 60%).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work effectively both independently and as part of a hybrid team.
Clinical Research Associate (Pharmaceutical)
Posted 14 days ago
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Job Description
Responsibilities:
- Monitor clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
- Verify the accuracy, completeness, and quality of clinical trial data.
- Conduct site initiation visits, routine monitoring visits, and close-out visits.
- Train site staff on study procedures, regulatory requirements, and data collection.
- Ensure proper source documentation and case report form (CRF) completion.
- Identify and resolve issues at clinical trial sites, escalating as necessary.
- Communicate effectively with investigators, site staff, study teams, and management.
- Prepare and submit monitoring visit reports in a timely manner.
- Oversee drug accountability and investigational product management at sites.
- Ensure subject safety and ethical conduct of research at all times.
- Track and report on study progress, timelines, and key performance indicators.
- Assist in the preparation of regulatory submission documents.
- Maintain up-to-date knowledge of pharmaceutical industry regulations and clinical research best practices.
- Participate in team meetings and contribute to study strategy discussions.
- Manage multiple clinical trial sites remotely and effectively.
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related healthcare field.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial management role.
- In-depth knowledge of GCP guidelines, regulatory requirements (e.g., FDA, EMA), and clinical trial phases.
- Proven experience in site monitoring and data verification.
- Excellent understanding of medical terminology and research methodologies.
- Strong organizational, time-management, and problem-solving skills.
- Exceptional written and verbal communication skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently, manage travel (if occasional required), and prioritize tasks effectively in a remote setting.
- A proactive approach to identifying and resolving issues.
- Commitment to maintaining data integrity and subject confidentiality.
Clinical Research Associate (Pharmaceutical)
Posted 16 days ago
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Job Description
Key Responsibilities:
- Monitor clinical trial sites to ensure adherence to study protocols, SOPs, and GCP guidelines.
- Verify the accuracy, completeness, and source data integrity of clinical trial records.
- Conduct site initiation, interim monitoring, and close-out visits as per the monitoring plan.
- Build and maintain strong working relationships with principal investigators and site staff.
- Ensure timely reporting of study progress, deviations, and adverse events.
- Train site personnel on study-specific procedures and regulatory requirements.
- Manage investigational product accountability at trial sites.
- Assist with regulatory submissions and audits as required.
- Identify potential site issues and implement corrective actions promptly.
- Contribute to the development and review of clinical trial documents.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a related clinical trial management role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Experience with various phases of clinical research is essential.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent communication, interpersonal, and organizational skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to manage multiple priorities and travel as required for site monitoring.
- A valid driver's license and reliable transportation are necessary for site visits.
Clinical Research Associate - Pharmaceutical
Posted 5 days ago
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Job Description
Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocols, GCP, and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Screen, recruit, and inform potential study participants.
- Conduct site initiation visits, interim monitoring visits, and close-out visits.
- Manage communication between the sponsor, research sites, and investigators.
- Train site personnel on study-specific procedures and protocols.
- Oversee the safe and ethical conduct of clinical trials.
- Identify and resolve site issues and discrepancies in a timely manner.
- Ensure the proper handling and storage of investigational products and biological samples.
- Prepare monitoring reports and provide feedback to the clinical study team.
We are looking for individuals with a strong background in life sciences, nursing, or a related field, coupled with hands-on experience in clinical trial monitoring. Excellent understanding of Good Clinical Practice (GCP) and regulatory guidelines is paramount. Exceptional organizational, communication, and problem-solving skills are required. The ability to work independently and manage multiple tasks in a remote setting is crucial. This role is based in Mlolongo, Machakos, KE but offers a fully remote working environment.
Clinical Research Associate - Pharmaceutical
Posted 11 days ago
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Job Description
Key Responsibilities:
- Conduct pre-study, initiation, monitoring, and close-out visits at clinical trial sites according to study protocols and standard operating procedures (SOPs).
- Verify the accuracy, completeness, and integrity of clinical trial data by reviewing source documents and case report forms (CRFs).
- Ensure compliance with study protocols, GCP, and all applicable regulatory requirements.
- Monitor patient safety and report adverse events and serious adverse events promptly.
- Train site staff on study procedures, protocols, and regulatory requirements.
- Manage site-specific documentation and maintain essential trial files.
- Build and maintain positive working relationships with investigators and site staff.
- Identify and resolve site-specific issues and escalate critical issues to the clinical operations manager as needed.
- Participate in the preparation of study-related documents and reports.
Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or a related scientific field.
- Minimum of 3 years of experience as a Clinical Research Associate or equivalent role in the pharmaceutical industry.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in monitoring clinical trial sites and ensuring data quality.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong organizational, time management, and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to effectively interact with healthcare professionals.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Willingness and ability to travel frequently to assigned clinical trial sites.
- Ability to work effectively both independently and as part of a hybrid team.
Clinical Research Associate - Pharmaceutical
Posted 8 days ago
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Job Description
Clinical Research Associate - Pharmaceutical
Posted 22 days ago
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Job Description
- Monitoring clinical trial progress at assigned sites to ensure compliance with protocols, SOPs, and GCP.
- Conducting pre-study, initiation, interim, and close-out visits at clinical trial sites.
- Verifying the accuracy, completeness, and integrity of clinical trial data.
- Ensuring timely submission of regulatory documents and ethical committee approvals.
- Communicating effectively with investigators, site staff, and study sponsors.
- Identifying and resolving site-level issues and escalating problems as needed.
- Maintaining accurate and up-to-date trial documentation and records.
- Assisting with the recruitment and selection of study sites and investigators.
- Monitoring subject safety and reporting adverse events promptly.
- Preparing monitoring visit reports and following up on action items.
Qualifications:
- Bachelor's degree in a life science, nursing, or related healthcare field.
- Minimum of 5 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Experience with various therapeutic areas and trial phases.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to build rapport with site personnel.
- Ability to work independently, manage a remote workload effectively, and travel as required for site visits.
- Detail-oriented with a strong commitment to data accuracy and patient safety.
- Fluency in English is essential; additional language skills are a plus.
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Clinical Research Associate - Pharmaceutical
Posted 22 days ago
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Job Description
Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulations (e.g., GCP, FDA).
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Manage study conduct from site initiation to site closure.
- Build and maintain strong relationships with investigators and site staff.
- Conduct pre-study, initiation, interim, and close-out monitoring visits.
- Ensure investigational product accountability and proper storage.
- Review and process source documents and case report forms (CRFs).
- Identify, report, and escalate any safety concerns or protocol deviations.
- Prepare monitoring visit reports and follow-up on action items.
- Contribute to the development and review of study-related documents.
Qualifications:
- Bachelor's degree in a life science, nursing, or a related healthcare field.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA) or equivalent role.
- In-depth knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Experience in monitoring multiple clinical trial sites.
- Strong understanding of medical terminology and disease states relevant to pharmaceutical research.
- Excellent organizational, problem-solving, and analytical skills.
- Effective written and verbal communication skills for remote interactions.
- Ability to travel to investigational sites as required (up to 60%).
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Demonstrated ability to work independently and manage time effectively in a remote setting.
This position is conceptually located in Nakuru, Nakuru, KE , but is predominantly a remote role with required site visits.
Clinical Research Associate (Pharmaceutical)
Posted 1 day ago
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