Job Description
The Clinical Research Coordinator I (CRC I) is responsible for assisting with the day-to-day activities of clinical research studies under the supervision of the Principal Investigator (PI) or Clinical Research Nurse and in accordance with Good Clinical Practice (GCP) guidelines, FDA regulations, and institutional policies. The CRC I is responsible for assisting with study operations, participant recruitment, and data management contributing to the overall success of clinical trials. This is an entry-level role for individuals seeking to develop their career in clinical research.
#CB
Responsibilities Program Management
1. Assist in the coordination of clinical research studies, including study start-up, execution, and close-out activities.
2. Ensure all study activities are conducted in compliance with the study protocol, GCP, and relevant regulatory guidelines.
3. Screen, recruit, and enroll study participants according to the inclusion/exclusion criteria outlined in study protocols and as instructed by the PI.
4. Obtain informed consent from study participants and ensure their understanding of study procedures.
5. Conduct basic clinical assessments such as taking vitals and or administering questionnaires.
6. Provide information and support to participants throughout the study period.
Job Quality
1. Accurately collect, record, and maintain study data in case report forms (CRFs) or electronic systems.
2. Collect and process biological samples, such as blood, urine, or tissue, following proper clinical and laboratory procedures.
3. Monitor and report any adverse events, deviations, or protocol violations in a timely manner.
4. Coordinate patient visits, follow-ups, and schedule necessary procedures and tests according to protocol.
5. Ensure the safety of participants by following established safety protocols and guidelines.
6. Conduct study visits and assessments according to study protocols.
Collaboration and Partnership
1. Maintain open communication with the PI, clinical research team, and external study sponsors.
2. Provide regular updates to the research team regarding study progress, recruitment, and any issues encountered.
3. Serve as the main point of contact between study participants and the research team, ensuring clear communication of study procedures and addressing participant concerns.
4. Participate in study meetings with the research team and investigators and provide updates and contribute to problem solving discussions.
5. Assist with the completion of study close-out activities, including final study visits and data reconciliation.
6. In industry-sponsored trials, the CRC I may interact with study sponsors or Contract Research Organizations (CROs) and be required to participate in monitoring visits and data audits checks.
Other duties as assigned.
Qualifications - Education: Bachelor's Degree in a related field (biology, healthcare, nursing).
- Skills and Abilities: Effective communication, business writing, planning and organization, attention to detail, and Microsoft efficient.
- BLS
About Us Our Lady of the Lake Health provides care for a full range of illness or injury, including those that are extremely complex, for both pediatric and adult patients. We are a nonprofit, Catholic healthcare ministry based in Baton Rouge with more than 7,500 employees and more than 2,900 active physicians, including more than 600 employed physicians.
We are committed to building a healthy community through excellence in patient care and education. Being our best earns us the trust and loyalty of our community, and our culture of excellence is directly tied to our mission. We believe in the value of receiving a broad range of healthcare from one trusted provider, and we pursue and provide a comprehensive range of advanced programs, treatments and technologies.
Job Tags
Full time, Contract work