Piper Clinical Solutions is currently seeking an In-House Clinical Research Associate in the area of Bethesda, MD. The In-House Clinical Research Associate (IHCRA) will be responsible for supporting a competitive Clinical Research Organization (CRO) for infectious disease, cardiology, and oncology clinical research studies.
Responsibilities for the In-House Clinical Research Associate:
- Will assist in the monitoring of site visit preparation and/or executing meeting agenda preparation, regulatory file reviews, and arranging teleconferences
- Obtaining and maintaining more than 75 studies and reviewing 1500+ regulatory documents per month through the Trial Master File (TMF) and other internal databases
- Preparing SIV or Site Initiation Visit presentations and reviewing site monitoring plans
- Reviewing the regulatory documents for completeness and veracity necessary to comply with FDA guidelines, ICH GCP, and sponsor requirements
- Assisting with troubleshooting of database, eTMF, and regulatory documentation issues by applying problem-solving skills and existing knowledge
Qualifications for the In-House Clinical Research Associate:
- 1+ year of clinical trial/clinical research experience
- Experience with TMF and Veeva Vault
- Knowledge of guidelines set by IRB, FDA, ICH, GCP
- Bachelor’s Degree in Science or any Health-related field (Master’s, PhD preferred)
Compensation for the In-House Clinical Research Associate:
- Salary range: $60,000 - $85,000 (based on relevant experience)
- Benefits include: Health, Dental & Vision Insurance, 401k
Keywords:
Clinical Research Associate, CRA, site management, SIV, Site Initiation Visit, good clinical practice, GCP, trial master file, TMF, eTMF, ICH, International Council on Harmonization, FDA, food and drug administration, IRB, Institutional Review Board, regulatory affairs, IND, Investigational New Drug Application, ACRP, Association of Clinical Research Professionals, CTMS, Clinical Trial Management System, ICF, Veeva Vault