Role Overview
Join a medical technology organization in Santa Rosa, CA, as a Clinical Research Specialist on a 5-month contract with possible extension. In this role, you will play a key part in ensuring clinical studies are conducted efficiently and in alignment with regulatory standards. You will work closely with clinical teams, investigators, and external partners to support study operations from initiation through data review.
Key Responsibilities
- Support the execution of clinical studies in compliance with applicable regulations, policies, and internal procedures.
- Prepare and distribute study-related materials, including training documents and start-up packets.
- Coordinate with investigators and site personnel to ensure proper onboarding and training.
- Assist in launching study sites by managing documentation, tracking submissions, and verifying completeness.
- Collaborate with data management teams to review clinical data and support corrections as needed.
- Help coordinate meetings, training sessions, and conference calls involving internal and external stakeholders.
- Support oversight of third-party vendors such as contract research organizations and core labs.
- Follow established Standard Operating Procedures (SOPs) and contribute to their ongoing improvement.
- Engage in professional development activities to maintain and expand clinical research knowledge.
- Perform administrative duties including filing, document tracking, and record maintenance as required.
Qualifications
Candidates must demonstrate prior experience in clinical research and the ability to manage multiple priorities effectively. Strong written and verbal communication skills are essential, along with a consistent focus on accuracy and attention to detail. Familiarity with regulatory guidelines and clinical study workflows is highly valued. The ideal candidate is self-directed, organized, and able to adapt to evolving project needs.
