Job Details

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.

About Us

Our Lady of the Lake is uniquely capable of caring for a full range of illness or injury, including those that are extremely complex, for both pediatric and adult patients. Our family of services includes:

• An 988-bed hospital and the area's only Level II Trauma Center
• A freestanding Children's Hospital
• A 545-provider care network covering more than 40 specialties
• Two free-standing emergency rooms-Our Lady of the Lake Livingston and Our Lady of the Lake North
• A network of nearly 15 urgent care clinics
• Outpatient imaging and surgery centers
• Assumption Community Hospital
• Franciscan Missionaries of Our Lady University
• Our Lady of the Lake Ascension, a 78-bed, community hospital providing emergency, inpatient, outpatient, and surgical services to Ascension Parish and surrounding areas

We serve 38,000 inpatients and 820,000 outpatients annually and are committed to building a healthy community through excellence in patient care and education. A part of the Franciscan Missionaries of Our Lady Health System, Our Lady of the Lake is consistently awarded for compassionate care, clinical expertise, leading edge technology and innovation.