We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.
We are seeking an experienced Sr. Clinical Research Associate (CRA) to support our clinical operations team. The Sr. CRA will act as project resource to clinical site, sponsor, and Experien Group personnel regarding the product under test and the clinical trial conduct. The person will participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of medical devices. Under management supervision, CRAs monitor assigned clinical trials to ensure adherence to Federal regulations, clinical protocol, company policies, and any other applicable procedures.
MAJOR DUTIES OF POSITION:
- Responsible for ensuring that the site coordinators and investigators comply with the study protocol, Good Clinical Practices (GCP), Code of Federal Regulations (CFR) and Institutional Review Board (IRB)/Ethics Committee (EC) requirements.
- Act as primary liaison to the site. Activities may include site qualification visits, site initiation visits and training, monitoring visits to review the study data and verify the accuracy of the data against the site’s medical records, and site close-out visits.
- Contribute to protocol and CRF development as well as progress reports and the final clinical study report at study conclusion to report the study results to the FDA and other regulatory authorities.
- Ensuring data quality by maintaining compliance, reviewing adverse events and device complaints, reviewing audit reports, and implementing corrective actions (when needed).
- Support maintenance of department SOPs and work instructions.
- Support investigational device administration including all documentation for forecasting, shipping, receiving, disposition, complaints, and returned goods.
- Support and maintain documentation of all clinical research activities, e.g. site communications, correspondence, inventory information.
- Assist with site start-up activities, including collection of site personnel documents and with supervision, review of clinical site-specific informed consents.
- Ensure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions.
- Maintain working knowledge of clinical trial regulations for applicable geographies and types of studies. Serves as a resource related to clinical trial regulations.
- Drive trial enrollment and identify and communicate potential and actual obstacles to enrollment.
- Travel requirement: 25-50%
KNOWLEDGE AND SKILL REQUIREMENTS:
- A minimum of 3 years of directly related work experience or equivalent in clinical research, including work on medical device trials
- RN, BSN, or BS/BA in a relevant scientific discipline
- Knowledge of GCPs, CFRs and IRB procedures
- Accuracy, reliability, and high level of attention to detail
- Strong level of professionalism, including verbal and written skills
- Proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint
- Ability and willingness to travel
- Medical, Dental and Vision Benefits
- 18 Days of Paid Time-Off (PTO)
- 11 Paid Holidays
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.