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Clinical Trials Coordinator
2 months ago
Position: Clinical Trial Associate
Company: ACL Digital
Overview:
The Clinical Operations team at ACL Digital is pivotal in executing Phase I - IV clinical trials across various therapeutic areas. This role is essential in ensuring that all clinical studies are conducted in compliance with established protocols, company policies, and regulatory standards, ultimately delivering high-quality clinical data to support product registration and commercialization.
Key Responsibilities:
- Act as the primary operational contact for biomarker and bioanalytical strategies, collaborating with both internal and external stakeholders.
- Participate in multiple clinical study teams, contributing to the planning and coordination of operational activities related to biological specimen management.
- Provide expertise in sample management to various study management teams, ensuring the integrity and quality of biological samples collected.
- Serve as the main liaison between study management teams and laboratory vendors, overseeing day-to-day operations to meet project deliverables.
- Evaluate scientific proposals and protocols, assessing feasibility for clinical operations.
- Foster strong relationships across functional teams to ensure effective execution of biomarker strategies.
- Identify potential operational challenges proactively and collaborate with senior team members to develop resolution plans.
- Organize and lead operational meetings with study functional groups and vendors.
- Maintain internal databases and document repositories related to biomarker and bioanalytical operations.
- Review and interpret relevant study documents, including protocols and informed consent forms.
- Contribute to the development of requests for proposals (RFPs) and assist in the selection of contract research organizations (CROs) and vendors.
- Participate in project meetings and conference calls with vendors and cross-functional teams.
Qualifications:
The ideal candidate will possess a strong educational background in life sciences, with a minimum of:
- PharmD / PhD with 2+ years of relevant clinical experience.
- MA / MS with 3+ years of relevant clinical experience.
- BA / BS / RN with 5+ years of relevant clinical experience.
Skills and Knowledge:
- Demonstrated ability to learn quickly and adapt to changing project needs.
- Proficient in managing all aspects of study management from initiation to completion.
- Thorough understanding of regulatory requirements and clinical study best practices.
- Familiarity with medical and scientific terminology.
This position offers a unique opportunity to contribute to impactful clinical research initiatives within a dynamic and collaborative environment.
