Columbia, MD, USA
Reports to: Head of Clinical Operations
Location of position:Remote
Position type: Full-time
POSITION SUMMARY:Prepare and maintain documentation and run clinical investigations/clinical activities in compliance with medical device legislation and regulation.
Essential Functions and Responsibilities:
- Manage all aspects of a clinical trial or study at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations, and data integrity
- Support site recruitment and adhere to appropriate safety regulations and data integrity for non-clinical trials and studies
- Conduct monitoring activities of assigned clinical trials in compliance with the protocol, and all applicable local laws and regulations, company policies and quality standards as defined in the clinical trial
- Manage onsite activities to ensure the collection of accurate clinical data within given timelines
- Scientifically monitors clinical studies, which includes but is not limited to, reviewing of case report forms (CRFs) and source documentation to ensure adherence to the protocol, reliability, and scientific validity of the data
- Assist clinical, health economics, market access, and marketing teams with project-related activities, e.g. feasibility, enrollment, recruitment, and status reports
- Provide reports on onsite qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
- May be involved in the preparation of documentation for submission to IRB/IECs and CAs as well as coordination of submission with appropriate site staff and/or Project Manager/CRA Manager
- May assume responsibility for multiple studies.
- Create clinical and health economics databases with relevant literature
- Travel as needed (up to 60%)
Qualifications / Education:
- Graduate degree in Clinical Research, Clinical Research Administration, or related discipline with clinical research area of focus.
- Strong preference for additional clinical research certifications such as Association of Clinical Research Professionals Certification Programs, Clinical Research Society Certified Clinical Research Associate, etc.
- Clinical background: RN/PA/RT (Preferred)
- 5+ years direct clinical research experience in the medical device, pharmaceutical, biotechnology or CRO industry
- Previous experience with successful site recruitment and completion of studies
- Experience with scientific methods and literature analyses, preferred
- Excellent working knowledge of clinical research processes, good clinical practices, federal regulations and applicable local laws pertaining to clinical research investigations
- Understands and complies with medical device quality procedures and instructions
- Strong knowledge base of medical terminology
- Excellent written and verbal communication skills