Clinical Trial Associate

Clinical Trial Assistant

The Clinical Trial Assistant plays a crucial role in supporting clinical trial coordination and implementing clinical operational plans in line with regulatory guidelines and ICH/GCP standards. This individual contributor position involves managing study-specific reports, as well as site and vendor management activities throughout the entire study lifecycle, from start-up to database archive. Collaboration with CROs and cross-functional teams is essential.

Responsibilities

• Provide clinical operations support for study-specific reports.
• Manage site and vendor activities throughout the study lifecycle.
• Collaborate with CROs and cross-functional teams.
• Ensure adherence to regulatory guidelines and ICH/GCP standards.
• Maintain detailed and precise records and resolve issues promptly.
• Prioritize tasks and resources to meet deadlines.

Essential Skills

• Bachelor's degree required.
• 3-5 years of experience in the biotech industry and clinical drug development or trial execution.
• Advanced skills in Microsoft Office and knowledge of electronic data systems.
• Strong communication, organizational, and interpersonal skills.
• Independent decision-making and analytical skills.

Additional Skills & Qualifications

• Experience with TMF, preferably Veeva Vault.
• Global experience in clinical research.
• Experience in small biotech or startup environments is strongly preferred.
• 3+ years of clinical research experience, preferably with a sponsor or CRO.

Work Environment

The position offers flexibility with options for remote or hybrid work, with a preference for candidates in the Eastern Standard Time zone. Local candidates are preferred, as they may need to attend important team meetings on-site. The company is focused on precision genetic medicine targeting rare neuromuscular and cardiac diseases, with an emphasis on patient care and innovative genetic technologies.

Pay and Benefits

The pay range for this position is $45.00 - $55.00/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)

Workplace Type

This is a hybrid position in Parsippany-Troy Hills, NJ.

Application Deadline

This position is anticipated to close on Oct 15, 2025.