Under limited supervision but in compliance with policies and regulations, assists in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports(INDs), periodic reports, New Drug Applications (NDA’s) and Biological License Applications(BLA’s) etc. Participates in the design and writing of protocols, Case Report Forms (CRFs), and informed consent forms for clinical trials. Productive in recruitment/selection of new investigators, contract research organizations, and outside vendors to be used for the trials/studies. Responsible for planning and implementing all activities required to conduct and monitor complex clinical trials and insures that Good Clinical Practices (GCPs) are followed. Responds to questions and/or provides information upon request to clients (internal and external).
1. Identifies potential investigators, contract research organizations and outside vendors. Collects required documentation for review by Project Manager to make a selection decision.
2. Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout.
3. Prepares a variety of reports and letters in accordance with study SOPs and industry standards.
4. Collects, reviews and processes regulatory documents. Ensures adherence to study specific SOP’s, Good Clinical Practice (GCP) and FDA/ICH regulations.
5. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary.
6. Reviews patient status and investigator payment trackers.
1. BA/BS/MS/RN/BSN/LPN or related degree in a scientific, healthcare field or related field required.
2. Minimum 2 to 4 years previous related experience. Previous CRA experience highly preferred.
About Clintel Services, Inc.:
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