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Clinical Research Coordinator
2 months ago
Position Title: Clinical Project Assistant - II
Employment Type: Contract
Location: Foster City, California, USA
Work Arrangement: On-site
Role Summary:As a key member of the Clinical Operations team focusing on Biomarker and Bioanalytical Operations, you will play a vital role in supporting the initiation, management, and conclusion of clinical trials. Your responsibilities will include tracking and organizing study-specific data, participating in the quality assurance of documents, coordinating meetings, and assisting in the creation of essential documentation.
Key Responsibilities:- Maintain and organize study-specific information utilizing various databases and spreadsheets.
- Engage in the quality assurance processes for data and documentation.
- Coordinate logistics for meetings, including agenda preparation and minute-taking.
- Collaborate with cross-functional teams to ensure task completion.
- Assist in the development of standard operating procedures and documentation.
- Ensure compliance with established protocols, policies, and regulatory requirements.
- Support sample tracking and reconciliation for ongoing clinical studies.
- Utilize eTMF/Veeva systems for documentation management.
- Participate in presentations as required.
We value diverse backgrounds and experiences. The following qualifications are preferred:
- Advanced degree (MA/MS/PharmD/PhD) with relevant clinical experience in life sciences.
- Bachelor's degree (BA/BS) or Registered Nurse (RN) with at least one year of related experience.
- Basic understanding of clinical operations and business practices.
- Proficiency in Microsoft Word, PowerPoint, and Excel.
- Strong verbal, written, and interpersonal communication skills.
- Ability to learn quickly and adapt to changing environments.
- Team-oriented mindset with strong collaboration skills.
- Good analytical and organizational capabilities.
- Familiarity with FDA, EMA regulations, ICH guidelines, and GCP is advantageous.
- Effective communication skills with the ability to convey information clearly.
- Willingness to travel as necessary.
Since its inception in 2002, Maxonic has excelled in aligning candidate strengths with client needs. Our award-winning team of recruiting professionals specializes in technology and is dedicated to understanding and fulfilling the long-term career aspirations of our candidates. We take pride in our extensive track record of successful placements and the enduring relationships we build with our clients.