Clinical Research Associate (CRA)
A fast-growing biotech company dedicated to developing innovative therapies that address unmet medical needs and improve patient outcomes is seeking to add a Clinical Research Associate (CRA) to join their team. The companies dynamic team of researchers, scientists, and professionals work collaboratively to advance cutting-edge treatments in various therapeutic areas. This biotech company offers a unique and exciting opportunity for individuals seeking to work in an environment where passion, innovation, and collaboration are at the heart of everything they do. This dynamic organization has carved a niche for itself in the biotech landscape, focusing on cutting-edge research and development of novel therapeutics that have the potential to transform patient's lives.
The CRA will be responsible for monitoring and coordinating clinical trials to ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The successful candidate will collaborate with investigators, study coordinators, and site staff to ensure the smooth execution of clinical trials and accurate data collection, while contributing to the companies mission of advancing health care.
- Conduct site qualification, initiation, routine monitoring, and close-out visits to investigator sites.
- Verify adherence to study protocols, GCP, and applicable regulatory guidelines.
- Review and verify essential documents and source data at clinical sites.
- Collaborate with study personnel to resolve data discrepancies and ensure accurate data reporting.
- Monitor subject safety and report adverse events in a timely manner.
- Maintain detailed and organized study documentation, including site visit reports and monitoring visit findings.
- Assist in the preparation of study-related materials and contribute to the development of study protocols and other study documents.
- Ensure compliance with study timelines and milestones.
- Provide support during regulatory inspections and audits.
- Bachelor's degree in a relevant scientific field (e.g., life sciences, pharmacy, nursing, etc.).
- 2+ years of experience as a Clinical Research Associate or in a related clinical research role.
- Strong knowledge of ICH-GCP guidelines and regulatory requirements.
- Excellent communication and interpersonal skills, with the ability to work effectively with various stakeholders.
- Attention to detail and the ability to work independently and proactively.
- Flexibility to travel to clinical sites as required.