52 Senior Clinical Research Associate Remote jobs in whatjobs
Senior Clinical Research Associate (Remote)
Posted 22 days ago
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Senior Clinical Research Associate (Remote)
Posted 22 days ago
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Job Description
Senior Clinical Research Associate - Remote
Posted 22 days ago
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Job Description
Responsibilities:
- Identify, evaluate, and select potential clinical trial sites.
- Initiate and manage the regulatory and ethics committee submission processes.
- Conduct site initiation visits, interim monitoring visits, and close-out visits.
- Verify source data and ensure its accuracy against case report forms (CRFs).
- Monitor patient safety and ensure prompt reporting of adverse events.
- Provide training and ongoing support to site personnel.
- Ensure compliance with study protocols, standard operating procedures (SOPs), and GCP.
- Manage trial supplies and investigational product at study sites.
- Prepare monitoring reports and action plans for site remediation.
- Collaborate with cross-functional teams, including project managers, data managers, and medical monitors.
- Contribute to the development and review of study documents.
- Stay updated on regulatory requirements and industry best practices.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree is a plus.
- Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
- In-depth knowledge of ICH-GCP guidelines and local regulatory requirements.
- Proven experience in monitoring multi-center clinical trials.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently and manage multiple priorities effectively.
- Strong problem-solving and analytical skills.
- Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS).
- Fluency in English, both written and spoken.
Senior Clinical Research Associate (Remote)
Posted 22 days ago
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Key Responsibilities:
- Conduct remote and on-site monitoring visits to assess study conduct and adherence to protocols, SOPs, and regulatory requirements.
- Perform source data verification (SDV) to ensure the accuracy and completeness of clinical data.
- Manage relationships with clinical investigators and site staff, providing guidance and support throughout the trial lifecycle.
- Ensure timely enrollment of subjects and compliance with inclusion/exclusion criteria.
- Oversee drug/device accountability and management at study sites.
- Identify and report protocol deviations, adverse events, and serious adverse events according to regulatory guidelines.
- Train site personnel on study-specific procedures and regulatory compliance.
- Prepare monitoring reports, follow-up letters, and other essential study documentation.
- Participate in site selection, initiation, and close-out visits.
- Collaborate with cross-functional teams, including project managers, data managers, and medical monitors.
- Ensure all site activities are conducted in accordance with GCP, ICH, and other applicable regulations.
- Contribute to the development of study protocols, informed consent forms, and other trial-related documents.
Qualifications:
- Bachelor's degree in a life science, nursing, or a related scientific field. Advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate (CRA), with a proven track record in monitoring clinical trials.
- In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and other relevant regulatory requirements.
- Experience in monitoring various phases of clinical trials (Phase I-IV).
- Excellent understanding of medical terminology and clinical trial processes.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Exceptional written and verbal communication skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to sites as required (though the role is primarily remote).
- Demonstrated ability to work independently, manage time effectively, and prioritize tasks in a remote setting.
- Certification as a CRA (e.g., ACRP, SoCRA) is a strong asset.
This remote role offers a significant opportunity to contribute to life-saving pharmaceutical research while enjoying the flexibility of working from home. Join our dynamic team and advance your career in clinical research.
Senior Clinical Research Associate (Remote)
Posted 22 days ago
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Job Description
Responsibilities:
- Oversee and manage assigned clinical trial sites, ensuring compliance with study protocols and GCP guidelines.
- Perform site selection, initiation, interim monitoring, and close-out visits (primarily remote, with potential for on-site visits as needed).
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Ensure all required regulatory documentation is maintained and compliant.
- Monitor study progress, identify potential risks, and implement mitigation strategies.
- Serve as the primary point of contact for investigators and site staff.
- Train site personnel on study procedures, data collection, and regulatory requirements.
- Manage drug accountability and ensure proper storage and handling of investigational products.
- Prepare and submit monitoring visit reports in a timely manner.
- Collaborate effectively with study sponsors, CROs, and internal project teams.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field; advanced degree preferred.
- Minimum of 5-7 years of experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in managing multiple clinical trial sites and complex studies.
- Strong understanding of clinical trial processes, from initiation to close-out.
- Excellent monitoring, auditing, and problem-solving skills.
- Exceptional organizational, time management, and documentation skills.
- Outstanding written and verbal communication and interpersonal skills.
- Ability to work independently and effectively in a fully remote setting.
- Experience with various EDC (Electronic Data Capture) systems and CTMS (Clinical Trial Management Systems).
Senior Clinical Research Associate (Remote)
Posted 20 days ago
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Senior Clinical Research Associate (Remote)
Posted 20 days ago
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Job Description
Key Responsibilities:
- Perform remote site monitoring visits to ensure adherence to protocols, GCP, and regulatory guidelines.
- Verify the accuracy and completeness of clinical trial data by reviewing source documents and CRFs.
- Train and provide ongoing support to clinical trial site staff.
- Manage site initiation, routine monitoring, and site closure activities.
- Identify, document, and track protocol deviations and adverse events.
- Ensure timely resolution of site issues and data discrepancies.
- Maintain effective communication with investigators, site staff, and internal project teams.
- Prepare monitoring visit reports and ensure follow-up actions are completed.
- Oversee the management of investigational product and study supplies at the sites.
- Contribute to the development of study protocols, monitoring plans, and other trial-related documents.
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical or biotechnology industry.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Proven experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent understanding of clinical trial processes and documentation.
- Strong analytical, problem-solving, and organizational skills.
- Exceptional communication, interpersonal, and negotiation skills.
- Ability to work independently, manage time effectively, and meet deadlines in a remote environment.
- Attention to detail and commitment to data integrity and patient safety.
- Experience in multiple therapeutic areas is a plus.
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Senior Clinical Research Associate (Remote)
Posted 21 days ago
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Senior Clinical Research Associate (Remote)
Posted 21 days ago
Job Viewed
Job Description
Key Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits for clinical trials.
- Ensure adherence to study protocols, Standard Operating Procedures (SOPs), and regulatory requirements (e.g., GCP, FDA).
- Monitor patient safety and data integrity at assigned clinical trial sites.
- Identify, document, and track deviations and implement corrective and preventive actions (CAPAs).
- Build and maintain strong relationships with investigators, site staff, and study sponsors.
- Manage site-specific documentation and ensure its accuracy and completeness.
- Provide training and ongoing support to clinical site personnel.
- Review and reconcile clinical data, ensuring its quality and completeness.
- Prepare monitoring visit reports and communicate findings to the study team.
- Contribute to the development of study plans and protocols.
- 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).
- In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in conducting various types of monitoring visits (ISV, SIV, IVV, COV).
- Excellent understanding of clinical trial processes from start to finish.
- Strong medical knowledge relevant to pharmaceutical research.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Exceptional organizational, time management, and problem-solving skills.
- Outstanding written and verbal communication skills.
- Ability to work independently and effectively in a remote environment.
Senior Clinical Research Associate (Remote)
Posted 20 days ago
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Job Description
Qualifications:
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate.
- Proven experience in monitoring clinical trials across various phases and therapeutic areas.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Excellent understanding of clinical trial processes and documentation.
- Strong site management and monitoring skills.
- Exceptional communication, interpersonal, and problem-solving abilities.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel occasionally for essential on-site visits as needed (though the role is primarily remote).
- Demonstrated ability to work independently and manage workload effectively in a remote setting.