Clinical Study Associate

Clinical Study Associate

12+ Months Contract (Possible Extension or Conversion)

Basking Ridge, NJ (Hybrid)

Position Summary

The Clinical Study Associate I provides clinical and administrative support for the planning and execution of clinical studies under the close supervision of a Senior Manager or above within Clinical Operations. This role supports study teams, Contract Research Organizations (CROs), and vendors to ensure compliance with protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines. The position plays a key role in Trial Master File (TMF) support, study tracking, and quality oversight activities.

Key Responsibilities

Clinical Operations Support

• Assist in the planning and execution of clinical studies in compliance with protocols, GCPs, SOPs, FDA regulations, EU Directives, and ICH guidelines
• Provide day-to-day clinical administrative support to study teams
• Support interactions with CROs, Academic Research Organizations (AROs), and other vendors to help monitor compliance with Quality Oversight measures

Trial Master File (TMF) & Documentation

• Support the transmittal of trial- and site-level documents to the DS Document Control Center (DCC)
• Reconcile TMF document trackers generated by CROs with the DS document archive
• Identify and escalate TMF discrepancies or issues to the supervisor

Study Coordination & Communication

• Prepare meeting logistics, agendas, and minutes for:
• Study team meetings
• CRO and Investigator Meetings
• Meetings with AROs
• Coordinate with DS Regulatory Operations to collect and submit required information for public trial postings (e.g., )

Metrics & Tracking

• Track study metrics including:
• Site start-up
• Investigator and site performance
• Recruitment
• Regulatory documentation
• TMF filing and QC activities
• Analyze site metrics reports under supervision to identify potential risks or issues and escalate concerns
• Create and maintain tracking tools and spreadsheets (e.g., vendor invoices, study metrics, documentation status)

Additional Responsibilities

• Work with insurance brokers to obtain study site insurance under supervisor guidance
• Perform other administrative and operational tasks as required to support clinical studies

Required Qualifications

Education

• Bachelor's degree required

Experience

• Minimum of 1 year of relevant experience required
• Relevant experience may include:
• Pharmaceutical, biotech, or medical device/diagnostic companies
• Contract Research Organizations (CROs)
• Academic Research Organizations (AROs)
• Clinical research site experience (e.g., Study Site Coordinator)
• Time spent directly in a medical or clinical research environment

Skills & Competencies

• Basic knowledge of clinical research processes and regulations
• Working proficiency in:
• Microsoft Word
• Excel
• PowerPoint
• Outlook
• Basic oral and written communication skills
• Strong organizational and tracking skills with attention to detail

Job Type: Contract

Pay: $ $42.00 per hour

Expected hours: No less than 40 per week

Application Question(s):

• Do you have experience in any of them (Pharmaceutical, biotech, or medical device/diagnostic companies)?

Education:

• Bachelor's (Required)

Experience:

• Clinical research site (e.g., Study Site Coordinator): 1 year (Required)
• CRO/ARO: 1 year (Preferred)

Work Location: Hybrid remote in Basking Ridge, NJ 07920