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Job #02591

About our client Our client is a clinical research company founded in 1977 with two sites, one in Port Chester, NY and one in Rockland, Maine. Position Location Clinical Study Coordinator Rockland, ME Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee regulatory document preparation and IRB submission 2) Complete source documents (and create them if necessary) 3) Submit ads and track invoices 4) Schedule PIs and sub-Is 5) Ensure completion of proper sign-in 6) Monitor contact and visit schedules 7) Create ads, facilitate recruiting and telephone screening 8) Screen subjects 9) Complete and maintain CRFs (electronic/paper) 10) Conduct subject visits/procedures 11) Update and fax screening/enrollment logs 12) Oversee completion of necessary information/signatures from PI/sub-I 13) Ensure proper reconciliation and maintenance of study drug and other supplies 14) Complete required trainings (eCRFs, etc.) 15) Review and revise protocol as needed 16) Oversee recruiting and inform Site Manager of status/issues 17) Create source documents utilizing the checklist 18) Follow product delivery to ensure proper amount received, instructions, etc. 19) Review schedule for study staffing needs 20) Prepare for visits (rooms, supplies, instruments, etc.) 21) Ensure proper reconciliation and maintenance of study supplies 22) Prepare patient payment requests and ensure that correct payment is received from ADP 23) Oversee shipment of data and other materials to statistician, cuderm, etc. 24) Work within QA process 25) Prepare final report, and review and revise them as necessary 26) Ensure proper archiving of study paperwork 27) Track final report and keep the New York staff in loop 28) Ensure proper disposal of product 29) Perform clinical assessments and other tasks such as visual evaluations, instrumental evaluations and replicas, and product instructions and distribution 30) Ensure that all study milestones are met, or that issues concerning them are brought to the attention of the Site Manager 31) Participate in planning and staff meetings Requirements 1) Degree in a scientific discipline/degree in another discipline along with medical and/or clinical certification/equivalent combination of education and work experience 2) Experience in study coordination or other aspects of clinical trials 3) Certification in CCRC or CCRP 4) Training in GCP a plus