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Senior Clinical Research Associate

r Regional Clinical Research Associate Identifies potential investigators, contract research organizations and outside vendors. Collects required documentation for review by Project Manager to make a selection decision. Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout. Prepares a variety of reports and letters in accordance with study SOPs and industry standards. Collects, reviews and processes regulatory documents. Ensures adherence to study specific SOP’s, Good Clinical Practice (GCP) and FDA/ICH regulations. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary. Reviews patient status and investigator payment trackers. Maintains investigator files. Ensures files and credentials are current and contain required information. Assists with in-house review of Case Report Forms (CRF’s) to ensure they are in compliance and complete before submitting to Data Management. Process and track SAE’s. Performs other clinical research, operations and/or administrative duties as assigned. Minimum Requirements: EducationBA/BS/MS/RN/BSN/LPN or related degree in a scientific, healthcare field or related field preferred. Previous related experience. Oncology required. Demonstrated knowledge of medical terminology and medicinal products. PC proficient including Microsoft Office (Word, Excel, Power Point, Outlook) and the Internet. Excellent organizational, analytical, and problem-solving skills. Attention to detail a must. Ability to manage multiple projects/priorities simultaneously and produce the desired results. Ability to work with highly confidential information, take initiative and exercise good judgment. Excellent verbal, written, telephone and interpersonal communications skills. Must be able to travel 65% of the time.  

Hampton, Virginia