2 Senior Clinical Research Associate Pharmaceutical Development jobs in whatjobs
Senior Clinical Research Associate - Pharmaceutical Development
Posted 21 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced and meticulous Senior Clinical Research Associate (CRA) to join their fully remote pharmaceutical development team. This role is integral to the successful execution of clinical trials, ensuring adherence to protocols, regulatory standards, and data integrity. You will be responsible for monitoring clinical trial sites, verifying data accuracy, managing investigational product, and ensuring patient safety. The ideal candidate possesses a deep understanding of Good Clinical Practice (GCP) guidelines, pharmaceutical development processes, and a strong ability to manage multiple sites and complex trial requirements remotely. This position offers a unique opportunity to contribute to life-saving drug development from the convenience of a remote work environment, collaborating with a global network of researchers and clinicians.
Key Responsibilities:
Key Responsibilities:
- Conduct remote site initiation, monitoring, and close-out visits according to protocol and GCP.
- Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV).
- Ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA) and study protocols.
- Manage investigational product accountability and ensure proper storage and handling at trial sites.
- Serve as the primary point of contact for assigned clinical trial sites, addressing site staff queries and issues.
- Identify, track, and resolve data discrepancies and protocol deviations.
- Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
- Provide training and ongoing support to site personnel.
- Prepare and present site monitoring reports.
- Collaborate with internal teams, including clinical operations, data management, and regulatory affairs.
- Bachelor's degree in a life science, nursing, pharmacy, or a related discipline. Advanced degree preferred.
- Minimum of 5 years of progressive experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Strong understanding of clinical trial processes, from study start-up to close-out.
- Excellent analytical, problem-solving, and organizational skills.
- Exceptional communication, interpersonal, and negotiation skills, particularly in managing remote relationships.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently, manage time effectively, and travel as needed (though the role is primarily remote).
- Relevant certifications (e.g., ACRP, SoCRA) are a plus.
This advertiser has chosen not to accept applicants from your region.
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Senior Clinical Research Associate - Pharmaceutical Development
Posted 6 days ago
Job Viewed
Job Description
Our client, a leader in pharmaceutical innovation, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join our fully remote team. In this critical role, you will be responsible for the oversight and management of clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will play a vital part in bringing life-changing therapies to patients by meticulously monitoring study sites, ensuring data integrity, and collaborating with investigators and site staff. This position demands exceptional organizational skills, a keen eye for detail, and a strong understanding of pharmaceutical research and development processes.
Responsibilities:
Responsibilities:
- Perform site selection, initiation, monitoring, and close-out visits for clinical trial sites.
- Ensure compliance with study protocols, standard operating procedures (SOPs), and applicable regulatory requirements (GCP, ICH).
- Verify the accuracy, completeness, and integrity of clinical data collected at study sites.
- Monitor patient safety and report adverse events according to established procedures.
- Train and provide ongoing support to site personnel, including investigators and study coordinators.
- Manage and track study-related supplies and essential documents.
- Build and maintain strong relationships with investigators, site staff, and internal project teams.
- Prepare and submit monitoring reports and follow up on action items.
- Contribute to the development and review of clinical trial protocols and other study documents.
- Identify potential risks and issues at study sites and implement corrective and preventive actions (CAPA).
- Stay up-to-date with industry trends and regulatory changes in clinical research.
- Participate in protocol amendments and study amendments as required.
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 5 years of progressive experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent understanding of clinical trial processes, from initiation to close-out.
- Strong data verification and query resolution skills.
- Exceptional organizational, time management, and problem-solving abilities.
- Effective written and verbal communication skills, with strong interpersonal abilities.
- Ability to work independently, manage a remote workload efficiently, and travel to sites as required (though the primary role is remote).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Relevant certifications (e.g., ACRP, SoCRA) are a plus.
This advertiser has chosen not to accept applicants from your region.
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