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
Similar Jobs
Biotech
Hunt and qualify biotech opportunities for clinical supply services, perform targeted outreach, support RFP submissions in Salesforce, coordinate CDAs and account setups, act as commercial lead for a small portfolio, and use BI tools to advance business (remote West Coast, ~25% travel).
Top Skills:
Business Intelligence PlatformsCRMSalesforce
Biotech
Lead design and delivery of clinical trial operational strategy, chair Study Management Teams, manage CRO partners to ensure on-time, on-budget, and compliant execution across trial phases, drive risk mitigation and cross-study synergies, and establish efficient team operations to support patient-focused drug development.
Top Skills:
CroGCPGlobal Clinical Operations (Gco)Ich Guidelines
Biotech
Lead global clinical trial disclosure and transparency strategy ensuring timely, compliant registrations, results disclosure and lay summaries. Oversee redaction/anonymization of CCI, guide cross-functional stakeholders, manage vendors and disclosure systems, track metrics, and implement process improvements aligned with international regulations and company policy.
Top Skills:
Clinicaltrials.GovCtisTrialscope Disclose
What you need to know about the NYC Tech Scene
As the undisputed financial capital of the world, New York City is an epicenter of startup funding activity. The city has a thriving fintech scene and is a major player in verticals ranging from AI to biotech, cybersecurity and digital media. It also has universities like NYU, Columbia and Cornell Tech attracting students and researchers from across the globe, providing the ecosystem with a constant influx of world-class talent. And its East Coast location and three international airports make it a perfect spot for European companies establishing a foothold in the United States.
Key Facts About NYC Tech
- Number of Tech Workers: 549,200; 6% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Capgemini, Bloomberg, IBM, Spotify
- Key Industries: Artificial intelligence, Fintech
- Funding Landscape: $25.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Greycroft, Thrive Capital, Union Square Ventures, FirstMark Capital, Tiger Global Management, Tribeca Venture Partners, Insight Partners, Two Sigma Ventures
- Research Centers and Universities: Columbia University, New York University, Fordham University, CUNY, AI Now Institute, Flatiron Institute, C.N. Yang Institute for Theoretical Physics, NASA Space Radiation Laboratory
