2 Senior Clinical Research Associate jobs in whatjobs
Senior Clinical Research Associate
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company dedicated to advancing global health, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their esteemed team. This role offers a unique blend of field and remote work, contributing significantly to the successful execution of clinical trials. You will be responsible for monitoring trial progress, ensuring adherence to protocols, and maintaining the integrity of data collected from study sites. The ideal candidate possesses a deep understanding of GCP, regulatory requirements, and possesses exceptional organizational and communication skills. This is an excellent opportunity for a dedicated CRA to contribute to life-changing therapies within a hybrid work model.
Responsibilities:
Responsibilities:
- Conduct site initiation, monitoring, and close-out visits in accordance with clinical trial protocols and standard operating procedures (SOPs).
- Ensure that clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and all applicable regulations.
- Verify the accuracy, completeness, and validity of data reported by study sites.
- Train and guide site staff on trial-related procedures, documentation, and regulatory requirements.
- Manage communication between study sites and internal project teams.
- Resolve data discrepancies and ensure timely query resolution.
- Review essential documents for completeness and accuracy.
- Identify and report adverse events and protocol deviations.
- Contribute to the development of study protocols and other trial-related documents.
- Ensure timely submission of regulatory documents.
- Manage multiple clinical trial sites simultaneously.
- Prepare site visit reports and follow-up actions.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- Minimum of 5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical or biotech industry.
- In-depth knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements (e.g., FDA, EMA).
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent understanding of clinical trial processes and documentation.
- Strong critical thinking, problem-solving, and decision-making abilities.
- Exceptional communication, interpersonal, and organizational skills.
- Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel to clinical sites as required.
- Demonstrated ability to work independently and as part of a remote/hybrid team.
- Commitment to patient safety and data integrity.
This advertiser has chosen not to accept applicants from your region.
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Senior Clinical Research Associate
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their global team on a fully remote basis. This vital role will involve managing and overseeing clinical trials, ensuring compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out activities, acting as the primary liaison between the sponsor and clinical trial sites. You will conduct remote monitoring visits, review source documents, verify data accuracy, and ensure the safety and rights of study participants. The ideal candidate will possess a strong understanding of clinical trial operations, drug development processes, and regulatory affairs within the pharmaceutical industry. Proven experience in managing complex multi-center trials and a demonstrated ability to resolve site-level issues effectively are essential. This position requires exceptional organizational skills, meticulous attention to detail, and outstanding communication and interpersonal abilities. You will need to effectively manage relationships with investigators, site staff, and internal project teams. We are looking for a proactive, self-motivated professional who thrives in an independent, remote work environment. This is an excellent opportunity to contribute to the advancement of pharmaceutical research and development by ensuring the integrity and quality of clinical data. The ability to work autonomously, manage a diverse workload, and maintain a high level of professionalism in all interactions is critical.
Responsibilities:
Responsibilities:
- Oversee and manage assigned clinical trial sites to ensure adherence to protocols, GCP, and regulatory requirements.
- Perform remote and on-site monitoring visits to assess trial progress, data quality, and patient safety.
- Initiate, monitor, and close-out clinical trial sites according to study plans.
- Verify the accuracy and completeness of clinical data through source document review.
- Ensure timely reporting of adverse events and protocol deviations.
- Serve as the primary point of contact for investigators and site staff.
- Train site personnel on study-specific procedures and regulatory compliance.
- Manage essential study documents and regulatory binders.
- Collaborate with internal teams, including project managers, data managers, and safety personnel.
- Contribute to the development of study protocols and clinical trial plans.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 5 years of experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience in managing clinical trials across various therapeutic areas.
- Proven ability to conduct remote monitoring and data verification.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to build rapport with site staff.
- Demonstrated ability to work independently and manage a remote workload effectively.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Valid driver's license and willingness to travel occasionally for essential on-site activities.
This advertiser has chosen not to accept applicants from your region.
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