Piper Clinical Solutions is seeking a driven Senior Clinical Research Associate to support a growing biomedical company with medical device product development testing projects in Rockville, MD.
Responsibilities for the Senior Clinical Research Associate:
- Overall management for medical device studies from conception to closeout including monitoring, regulatory, quality assurance, communication with essential study personnel and reporting activities.
- Development of study documents: clinical study protocols (CSP’s), informed consent documents (ICD’s), case report forms (CRF’s) forms and other study documents
- Regulatory submission oversight and tracking through the Institutional Review Board (IRB) & Food and Drug Administration (FDA) including communication with the IRB & FDA to obtain approval of studies and related documents, and addressing non-conformance issues
- Contract Research Organization (CRO) selection and management through CRO assessments and their proposed scope of involvement
- Site feasibility analysis through site selection visits (Including CRO selected sites) and evaluation reports
- Serve as the liaison for investigators, CRO, and staff for study start-up activities and ensuring the compliance of initiated studies with affiliated regulatory protocols and regulations.
- Monitoring and supervision of clinical studies through monitoring visits, ensuring compliance with protocols, regulatory requirements, and good clinical practices
- Drafting follow-up visit reports and in cases of clinical study protocol deviation, providing guidance to the study site and project team regarding root cause analysis, impact assessment and any corrective action plans necessary
- Review site data and documentation to ensure quality of data
- Study close-out through verification of research files integrity (CRF’s and data files) and review, verification and confirmation of closure status with investigators
Requirements for the Senior Clinical Research Associate:
- 5+ years of CRA specific experience
- Experience monitoring/conducting Medical Device studies
- Knowledge and experience with IVD regulations and protocols
- Willingness to travel up to 60% and sit in Rockville site when not travelling
- Minimum of a Bachelor’s Degree in science-related field
Compensation for the Senior Clinical Research Associate
- Salary up to $110,000 upon meeting of requirements
- Benefits: PTO, Paid Holidays, Medical/Dental/Vision Insurance, 401K etc.
Please send all qualified resumes to: firstname.lastname@example.org
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