Clinical Research Associate
22 hours ago
This Clinical Research Specialist role is a key position within the Clinical R&D Department, responsible for supporting the execution of company-sponsored clinical trials. The successful candidate will ensure compliance with timelines and study milestones, working under general direction and in accordance with all applicable federal, state, and local laws/regulations, procedures, and guidelines.
Key Responsibilities- Support the execution of clinical trials, ensuring compliance with timelines and study milestones.
- Participate in the feasibility, selection, set up, conduct, and closure of clinical trials within allocated countries, in accordance with ICH-GCP, applicable legislation, and Company Standard Operating Procedures.
- Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
- Assist in the development of clinical trial documents, including study protocols, informed consents, CRFs, monitoring plans, study manuals, investigator brochures, and annual reports.
- Coordinate and execute the ordering, tracking, and managing of investigational products and trial materials.
- Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures.
- Minimum of a Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science.
- BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.
- Previous experience in clinical research or equivalent is desired.
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
- Clinical/medical background a plus.
- Medical device experience a plus.
- Connect - Develop collaborative relationships with key internal and external stakeholders.
- Shape - Actively participate in departmental process improvement activities.
- Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
- Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget, and in compliance to SOPs and regulations.
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