Job Description
1. Plans, coordinates, and manages the activities associated with the initiation and completion of clinical trials.
2. Maintains compliance with all regulatory bodies associated with human subject research.
3. Interfaces with clinical staff to identify patients eligible for clinical trials.
4. Provides in-service education to the appropriate clinic personnel in the departments involved with the investigational study.
5. Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure that they are informed prior to obtaining written consent.
6. Completes required follow-up and active patient monitoring per study protocol.
7. Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies.
8. Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies.
9. Performs other duties as assigned or required by the Director of Research and/or Principal Investigator.
10. Assists the Investigator in the daily activities of clinical research.
a. This includes, confirming informed consent has been obtained prior to clinical trial participation.
b. Collecting, maintaining and organizing study information.
c. Collect and record study data.
d. Input all information into designated database.
11. Confirm informed consent by the investigator(s) and educates participants regarding study requirements.
12. Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering electronic lifestyle questionnaires.
13. Maintains source documents and subject files in accordance with site procedures. Ensures accurate and complete compilation of subject data through chart reviews.
14. Prepares for monitoring visits.
15. Performs other protocol specific procedures/duties.
Experience: Minimum of 5 years of experience in related field, Pulmonology experience preferred.
Required skills:
Proven experience
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