6 Remote Clinical Research Associate Pharmaceutical jobs in whatjobs
Remote Clinical Research Associate - Pharmaceutical
Posted 22 days ago
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Job Description
As a remote CRA, your primary responsibilities will include remote monitoring of clinical trial sites, which may involve reviewing electronic trial master files (eTMF), source data verification (SDV) via remote access, and analyzing site performance data. You will conduct remote site initiation visits, interim monitoring visits, and remote close-out visits, ensuring sites are adequately prepared, well-managed, and compliant throughout the trial lifecycle. You will be responsible for training site staff on study protocols and procedures, addressing protocol deviations, and ensuring the timely resolution of data queries. Building and maintaining strong relationships with investigators and site staff is crucial for successful trial execution. You will also be tasked with ensuring the accurate and timely submission of essential documents and reports. The ability to travel occasionally for essential on-site visits (if required by specific project needs) should be considered, though the role is fundamentally remote. We are looking for a proactive, self-disciplined individual with excellent communication and problem-solving skills, committed to maintaining the highest standards of data integrity and patient safety. This is an excellent opportunity to contribute to groundbreaking pharmaceutical research from **Ruiru, Kiambu, KE**, with the flexibility and autonomy of a remote position.
Key Responsibilities:
- Perform remote monitoring of clinical trial sites to ensure compliance with protocols, SOPs, and GCP.
- Conduct remote site initiation, interim, and close-out visits via virtual platforms.
- Verify source data against electronic case report forms (eCRFs) through remote access methods.
- Train and support site staff on study conduct, regulatory requirements, and data management.
- Monitor site progress, identify potential risks, and implement corrective and preventive actions (CAPAs).
- Ensure the timely resolution of data queries and protocol deviations.
- Manage the trial master file (TMF) remotely, ensuring all essential documents are current and complete.
- Build and maintain strong working relationships with investigators, study coordinators, and other site personnel.
- Prepare and submit monitoring visit reports promptly.
- Ensure subject safety and data integrity throughout the trial.
- Stay current with relevant regulations, guidelines, and industry best practices.
- 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 similar clinical trial management role.
- Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Experience with remote monitoring techniques and electronic data capture (EDC) systems.
- Proficiency in using clinical trial management software (CTMS) and electronic trial master file (eTMF) systems.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote setting.
- Willingness to travel occasionally as required for essential on-site activities.
Remote Clinical Research Associate (Pharmaceutical)
Posted 5 days ago
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Job Description
Key Responsibilities:
- Perform remote site selection, initiation, monitoring, and close-out visits in accordance with study protocols and regulatory requirements.
- Ensure adherence to Good Clinical Practice (GCP), protocol amendments, and applicable regulatory guidelines.
- Monitor study conduct, data quality, and patient safety through remote review of source documents and data.
- Verify accuracy and completeness of clinical data through source data verification (SDV).
- Oversee site personnel training on study procedures, protocols, and regulatory requirements.
- Manage communication between study sites, investigators, and the clinical trial team.
- Prepare and submit monitoring visit reports and follow-up letters in a timely manner.
- Identify and address site-level issues and deviations, implementing corrective and preventative actions (CAPA).
- Maintain accurate and up-to-date trial documentation in electronic trial master files (eTMF).
- Ensure timely reporting of adverse events and protocol deviations.
- Support investigational product accountability and drug supply management at sites.
- Contribute to the development and review of clinical study protocols, informed consent forms, and other trial-related documents.
Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or a related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate, preferably with site monitoring experience.
- Thorough understanding of GCP, ICH guidelines, and local regulatory requirements.
- Proven ability to conduct remote monitoring and data review effectively.
- Excellent organizational, time management, and prioritization skills.
- Strong written and verbal communication skills, with the ability to interact professionally with healthcare professionals.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently with minimal supervision and manage a remote caseload.
- Detail-oriented with strong analytical and problem-solving skills.
- Willingness to travel occasionally for essential site visits or training as required (though the role is primarily remote).
- Relevant certifications (e.g., ACRP, SoCRA) are a plus.
Remote Clinical Research Associate (Pharmaceutical)
Posted 2 days ago
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Job Description
Responsibilities:
- Perform remote site management and monitoring activities in accordance with study protocols and GCP guidelines.
- Ensure compliance with all regulatory requirements (e.g., FDA, EMA, local regulations).
- Verify the accuracy, completeness, and integrity of clinical data through remote review and source data verification processes.
- Train and support site staff on study-specific procedures, regulatory requirements, and data collection.
- Manage study timelines and ensure timely data collection and query resolution.
- Prepare detailed monitoring visit reports and follow up on action items.
- Identify and report potential safety issues and adverse events according to protocol and regulatory requirements.
- Facilitate communication between study sites, the sponsor, and other relevant parties.
- Maintain all necessary study documentation and regulatory files.
- Contribute to the development and review of clinical trial protocols and other study documents.
- Manage multiple clinical trials and sites simultaneously.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 3-5 years of experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Experience with electronic data capture (EDC) systems and other clinical trial management software.
- Demonstrated ability to manage remote clinical trial sites effectively.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to travel as needed for essential on-site activities (if applicable, specify percentage).
- Proficiency in Microsoft Office Suite.
- Detail-oriented with a strong commitment to data integrity and patient safety.
- Previous experience in the pharmaceutical industry is highly desirable.
Remote Clinical Research Associate - Pharmaceutical
Posted 21 days ago
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Job Description
Responsibilities:
- Perform remote site monitoring visits and assess protocol compliance.
- Ensure accurate and timely collection, review, and verification of clinical trial data.
- Verify that study participants are enrolled and monitored according to the clinical trial protocol.
- Ensure the rights, safety, and well-being of study participants are protected.
- Train and support investigators and site staff on study procedures and requirements.
- Manage communication between study sites, the sponsor, and other stakeholders.
- Prepare and submit monitoring visit reports and action items.
- Oversee site adherence to GCP, FDA regulations, and other applicable guidelines.
- Track study milestones and timelines, identifying and resolving any potential delays.
- Maintain comprehensive study documentation and regulatory binders.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical research role.
- In-depth knowledge of clinical trial phases, GCP, ICH guidelines, and regulatory requirements.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to work independently and travel occasionally if required for specific site visits (though the role is primarily remote).
- Proficiency in Microsoft Office Suite.
- A secure home office environment with a reliable high-speed internet connection.
- Demonstrated ability to manage multiple tasks and prioritize effectively.
Remote Clinical Research Associate - Pharmaceutical
Posted 18 days ago
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Job Description
Remote Clinical Research Associate (Pharmaceutical)
Posted 8 days ago
Job Viewed
Job Description
Responsibilities:
- Perform remote monitoring of clinical trial sites to ensure adherence to study protocols, GCP, and applicable regulations.
- Verify the accuracy, completeness, and integrity of clinical trial data through source data verification (SDV) and remote data review.
- Ensure timely submission of essential study documents and facilitate communication between study sites and the central study team.
- Identify and report deviations from study protocols, adverse events, and safety concerns to the appropriate personnel.
- Monitor site progress and performance, providing feedback and implementing corrective actions as needed.
- Train and support site personnel on study-specific procedures, regulatory requirements, and data collection.
- Manage the logistics of clinical trial supplies and investigational product at assigned sites.
- Prepare monitoring reports, follow-up letters, and other required documentation.
- Participate in site initiation visits, interim monitoring visits, and close-out visits (may require some travel if specified by project needs).
- Collaborate with internal teams, including project managers, data managers, and medical monitors.
- Stay updated on current industry trends, regulatory changes, and best practices in clinical research.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience with remote monitoring techniques and technologies.
- Excellent understanding of clinical trial processes, study design, and data management.
- Strong analytical, problem-solving, and organizational skills.
- Exceptional written and verbal communication skills.
- Proficiency in using clinical trial management systems (CTMS), Electronic Data Capture (EDC) systems, and other relevant software.
- Ability to work independently, manage time effectively, and maintain a high level of productivity in a remote environment.
- Attention to detail and a commitment to data accuracy and regulatory compliance.
- Travel may be required periodically based on project needs.
This is a critical role offering the opportunity to contribute to life-changing pharmaceutical research from the flexibility of a remote work setting.
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