Support planning and execution of clinical trials by coordinating site communication, maintaining TMF and regulatory documents, tracking milestones, assisting data management and study start-up, and ensuring ICH-GCP and SOP compliance.
This is a remote position.
This role offers the opportunity to support the planning and execution of clinical trials while working collaboratively with cross-functional teams in the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
Requirements
Candidates should possess an Associate's or Bachelor's degree in one of the following disciplines:
- Psychology
- Life Sciences
- Biology
- Biomedical Science
- Public Health
- Health Sciences
- Nursing
- Healthcare Administration
- Medical Laboratory Science
- Related scientific or healthcare disciplines
Requirements
- Associate's or Bachelor's degree in a relevant field.
- Clinical research experience preferred
- Strong organizational and time management skills.
- Excellent written and verbal communication skills.
- High attention to detail.
- Proficiency with Microsoft Office (Excel, Word, Outlook, and PowerPoint).
- Ability to manage multiple priorities in a fast-paced environment.
- Working knowledge of ICH-GCP guidelines and clinical research processes is preferred.
- Support the day-to-day coordination of clinical trials.
- Maintain and organize Trial Master File (TMF) documentation.
- Assist with regulatory document collection and tracking.
- Coordinate communication with clinical sites, sponsors, and vendors.
- Track study milestones, deliverables, and timelines.
- Review study documentation for completeness and accuracy.
- Support investigator meetings and study start-up activities.
- Assist with data management and query resolution.
- Ensure compliance with Good Clinical Practice (ICH-GCP), company SOPs, and regulatory requirements.
- Prepare reports and maintain accurate study records.
BenefitsBenefits
- Competitive hourly compensation
- Flexible contract assignment
- Opportunity to gain experience supporting clinical trials
- Potential for contract extension based on business needs and performance
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