Clinical Study Associate I

Assist in planning and execution of clinical studies, under the supervision of the Study Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and ICH guidelines. Provide clinical trial management support to study teams and track CRO and vendor performance to ensure compliance with the Clinical Study Oversight Plan (CSOP).

• Reconcile TMF document trackers generated by the CRO with the document archive and propose remediation plans for issues.
• Distribute key study documents to the CRO and vendors.
• Provide clinical administrative support, including preparing meeting logistics, distributing agendas, and minutes for study meetings.
• Coordinate with Regulatory Operations to post trial information on public forums.
• Support the Fair Market Value process in evaluating study budgets.
• Review and document CRO-generated reports and elevate issues to the supervisor.
• Compile and maintain monitoring review spreadsheets and track study metrics.
• Analyze study site metrics reports to identify concerns and inform the supervisor.
• Create and maintain spreadsheets to track items such as vendor invoices.

• Experience managing an eTMF, preferably in Veeva Vault.
• Experience with meeting agendas and completing system access requests.
• Experience with CTMS systems and SharePoint site management.
• Familiarity with maintaining study team lists and study-specific trackers.
• Knowledge of clinical studies, regulatory issues, and compliance practices.
• Ability to interact appropriately with internal and external stakeholders.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

• Bachelor's degree (preferred in Life Sciences) with relevant clinical development experience.
• Experience in clinical or basic research in a Pharmaceutical company, Medical device/Diagnostic company, ARO, or CRO.
• Time spent directly in a medical environment, such as a Study Site Coordinator, is considered relevant.

This role requires 1-4 days onsite in Basking Ridge, NJ. The position is set in a dynamic environment where the team collaborates closely to manage and execute clinical studies, leveraging cutting-edge technologies and adhering to rigorous compliance standards.

This is a Contract position based out of Basking Ridge, NJ.

The pay range for this position is $35.00 - $42.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Basking Ridge,NJ.

This position is anticipated to close on Jan 23, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $35 - $42