This person will be responsible for the conduct of multiple clinical research activities. Ideal candidate will have industry sponsored clinical trial experience and/or project management experience for investigator initiated projects. Person is able to work with minimal supervision and within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, organizing site initiation visits. Person will be responsible for leading and managing the project from the standpoint of clinical research activities. Must be knowledgeable on and have full understanding of good clinical practices (GCP) and regulations. Will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources. Experience with cardiology clinical trials and industry sponsored studies preferred.
- Assist in the recruitment of study participants.
- Screen patient charts to identify eligible study patients.
- Review all prospective protocol patients' charts to evaluate protocol eligibility, advise investigators of needed tests to complete pre-treatment work-up.
- Assist in coordinating the collection of all protocol required laboratory testing (i.e. blood, bone marrow, urine, etc.) Extract data from study participants source documents.
- Assist the investigators in evaluating, documenting, and reporting adverse events and other safety related data.
- Conduct telephone screening calls for patients inquiring about their participation in clinical trials. Interact and educate patients and families to help them gain an understanding and alleviate any
- apprehension regarding the studies.
- Obtain written informed consent from patient allowing for free expression of fears, questions, etc., to ensure patient understanding.
- Ensure the accuracy and completeness of site regulatory documentation including but not limited to IRB and FDA approvals and reports, and adverse event documentation.
- Participate in site initiation, monitoring and close out visits.
*Current Florida RN license required.
