Project Coordinator I, Phase I Clinical Trials

About the Role

We are seeking a Project Coordinator I to join our Phase I clinical trials team, supporting first-in-human studies and the advancement of new therapeutics. This position is remote within the United States and involves working closely with project managers and cross-functional teams to maintain study organization and readiness for audits.

Responsibilities

• Coordinate and facilitate delivery of Phase I clinical trials, including studies at external sites.
• Develop and regularly update essential study documents such as project plans, communication plans, and risk registers.
• Monitor study timelines, milestones, and progress to ensure successful trial execution.
• Organize and lead study meetings by preparing agendas, documenting minutes, and ensuring follow-up on action items.
• Manage clinical trial management systems (CTMS) and electronic trial master files (eTMF), maintaining data accuracy and compliance.
• Serve as a key contact point for internal teams and external site personnel.
• Support feasibility assessments, start-up activities, and coordination with vendors.
• Participate in continuous improvement efforts and provide mentorship to junior staff members.

Requirements

• Bachelor's degree in life sciences or related field, or comparable experience.
• 2 to 3 years of clinical research experience, preferably with early phase clinical trials.
• Experience in project management support or study coordination within clinical research.
• Familiarity with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and overall clinical trial processes.
• Excellent organizational capabilities combined with strong communication and problem-solving skills.

Work Environment & Physical Demands

• The role is primarily office-based, with regular use of electrical office equipment.
• Occasional travel is expected, including domestic and some international trips, as well as site visits by car.
• Daily work involves prolonged sitting of 6-8 hours and repetitive hand movements.
• Some bending, crouching, twisting, and stooping are required.
• The position involves handling and occasionally lifting objects like laptops and luggage weighing up to 15-20 pounds.
• Regular attendance and flexible hours are necessary.

Compensation and Additional Information

The target hourly pay range is $28 to $30 USD. This role does not offer sponsorship and is open only to candidates residing in the United States. Candidates will have ongoing application opportunities.

Equal Employment Opportunity and Accommodations
We are committed to providing equal employment opportunities and reasonable accommodations as necessary.