Lead impactful clinical trial operations in a dynamic, remote setting. Collaborate with cross-functional teams to advance cardiovascular treatments. Gain valuable experience in vendor oversight and regulatory compliance.
Senior Clinical Trial Associate
in Healthcare + Life Sciences ContractJob Detail
Job Description
Overview
- Support late-stage cardiovascular clinical programs, ensuring compliance with protocols, SOPs, and regulatory guidelines.
- Collaborate with clinical trial teams to meet budget, timeline, and quality standards.
- Assist in managing and executing clinical studies to develop innovative treatments.
- Contribute to vendor oversight and budget management tasks.
- Perform periodic reviews and quality checks of the Trial Master File.
- Coordinate with CROs and other functions for site activation and essential document reviews.
- Prepare and assist with clinical documents, presentations, and reports.
- Participate in user acceptance testing for EDC and IRT systems.
- Support registry updates and system information entries for clinical studies.
Key Responsibilities & Duties
- Coordinate and track trial activities for compliance with protocols and regulatory guidelines.
- Capture and follow up on meeting minutes, decisions, and action items during trial-specific operations meetings.
- Assist in oversight of CROs and third-party vendors to meet study requirements.
- Review vendor invoices and track payments for budget management.
- Prepare and route clinical documents such as protocols, brochures, and informed consents.
- Perform QC reviews on Trial Master Files and ensure compliance with sponsor expectations.
- Coordinate essential document reviews for site activation with CROs and other functions.
- Assist with investigator meeting planning and study-related material production.
- Support user acceptance testing for clinical systems and registry updates.
Job Requirements
- Bachelor’s degree in life sciences or healthcare-related discipline required.
- Minimum 4 years of clinical research support experience in relevant industries.
- Knowledge of GCP and ICH guidelines essential.
- Proficiency in Microsoft PowerPoint, Excel, Word, and Smartsheet.
- Experience with TMFs, including periodic reviews and audits.
- Strong analytical, organizational, and time management skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Experience interacting with CROs and vendors for quality assurance.
- Travel may be required for specific tasks and assignments.
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