The Role
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.
Summary Generated by Built In
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
Skills Required
- Associate's or Bachelor's degree in a relevant field (psychology, life sciences, biology, biomedical science, public health, nursing, healthcare administration, medical laboratory science, or related)
- Clinical research experience
- Strong organizational and time management skills
- Excellent written and verbal communication skills
- High attention to detail
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint)
- Ability to manage multiple priorities in a fast-paced environment
- Working knowledge of ICH-GCP guidelines and clinical research processes
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The Company
What We Do
Allen Spolden specializes in clinical research operations management and provides tailored workforce solutions for clinical research organizations, pharmaceutical, biotech, and healthcare sectors. They offer services in clinical research, data management, regulatory affairs, and talent acquisition.
