Clinical Research Associate (IVD Studies)
The Clinical Research Associate helps to write clinical protocols for beta
site and formal clinical studies; and identifies, sets up and monitors clinical trials for new IVD (in vitro diagnostics and medical devices) investigational products, including instruments and test devices.
Additional responsibilities include:
- Identifies external sources for patient samples needed for product development and/or drafts protocols for external specimen collection.
- Provides guidance to product development teams about requirements for clinical field studies.
- Works closely with product development teams to provide clinical guidance, develop beta site and clinical trial protocols and to obtain clinical specimens needed for product development.
- Works closely with R&D and/or marketing to develop beta
- Site trial protocols and helps fulfill ongoing study product development needs.
- Monitors conduct of clinical studies.
- Prepares, handles, distributes, files, and archives clinical documentation and reports; reviews clinical study files periodically for accuracy and completeness.
- Prepares and distributes clinical trial supplies and maintains related tracking information. Tracks and manages Case Report Forms (CRFs) and Data Report Forms (DRFs).
- Participates in data entry, data auditing, clinical site queries and overall clinical data flow from the various clinical sites in a timely and professional manner.
- Prepares documentation for obtaining IRB/EC (Institutional Review Board or Ethics Committee) approvals.
- Actively participates in the analysis of data, including the drafting of clinical study reports.
Complies with the requirements of Good Clinical Practice (GCP), International Council for Harmonization (ICH), FDA regulations (U.S. CFR, Code of Federal Regulations), Quality System (ISO 13485) and relevant Standard Operating Procedures (SOPs) for clinical research.
- Maintains a high level of professional expertise through familiarity with clinical literature and current regulations.
- Interacts with study coordinators and study participants.
- Travels to clinical trial sites for study initiation, interim monitoring, and closure.
- Assists in identifying clinical trial sites. Initiates clinical studies on site, trains clinical and healthcare personnel, monitors progress of those studies, and engages in formal closure of on site clinical activities.
- Summarizes, analyzes and prepares field clinical trial data for inclusion in regulatory submissions and helps to design and maintain clinical trial databases and clinical files.
- May conduct readability studies to validate ease of use of test materials and reliability of draft procedures.
- Procures, manages and processes clinical specimens in support of development needs.
- Acts with supervision to determine methods and procedures on new assignments.
- The ideal candidate will have at least 2 years of clinical data monitoring experience, both in-house and in the field.
- Experience at a sponsor company is preferred, but not required.
- Strong knowledge of GCP is required.
- Bachelors degree in a science field is preferred, but not required with sufficient experience.
- Motivated, detail-oriented candidates with strong communication and interpersonal skills will be considered favorably.