Clinical Trial Associate

Kelly Services; City of Rochester (NY); On-site; USD 65,000 - 85,000; Full time

Job summary

Clinical Trials Associate position supporting a biotech client with a temp-to-hire path. You will assist in startup, conduct, and closeout of clinical studies, ensuring alignment with ICH-GCP, FDA regulations, and company procedures, while collaborating with cross-functional teams.

The role is remote with east coast time preference. A health-related bachelor’s degree and at least 3 years of trial experience, plus proficiency in Word, Excel, and Outlook, are required for success.

Qualifications

• Clinical trial experience and knowledge of GCP and FDA regulatory requirements.
• Ability to understand medical terminology and communicate effectively.
• Proficiency with Microsoft Word, Excel, and Outlook.

Responsibilities

• Support start-up activities including protocol and case report form development, IRB submissions, and TMF preparation.
• Coordinate documentation, study materials, training, and communications with trial sites.
• Assist with study conduct, monitoring, follow-up, and closeout processes.
• Maintain compliance with FDA regulations, GCP, study protocols, and SOPs.
• Track study-specific payments and invoices; provide operational workflow support.

Skills

Clinical trial experience

GCP knowledge

FDA regulations

Medical terminology

Communication skills

MS Office

Education

Bachelor’s degree in health-related profession or life science

Job description

Clinical Trials Associate — Open ended contract that could go perm in the future

Kelly® Science & Clinical is seeking a Clinical Trials Associate for a temp-to-hire opportunity supporting a client in the biotech sector. If you’re dedicated to advancing clinical research, maintaining Good Clinical Practice (GCP) standards, and thrive in a fast-paced, professional environment, trust The Experts at Hiring Experts to guide your next career move.

Location: Remote, east coast time zone preferred

Position Overview

In this role, you will support the implementation, conduct, and closeout of clinical studies under the guidance of Clinical Trial Management and Clinical Operations leadership. You will help ensure studies are conducted in alignment with investigational plans, applicable regulations, company procedures, and GCP requirements.

What You’ll Do

• Support clinical trial start-up activities, including clinical planning, protocol and case report form development, IRB submissions, investigator agreements, informed consent forms, site selection, and Trial Master File (TMF) preparation.
• Coordinate administrative documentation, study materials, training support, and communications with clinical trial sites.
• Assist with study conduct, monitoring coordination, follow-up activities, and study closeout processes.
• Help maintain compliance with FDA regulations, applicable international requirements, GCP, study protocols, and standard operating procedures.
• Support the tracking of study-specific payments and invoices.
• Provide operational and workflow support to help ensure clinical operations processes are completed accurately and efficiently.
• Collaborate with cross-functional partners, including Research & Development, Regulatory Affairs, Safety, Quality/Compliance, Data Management, Biostatistics, Legal, Finance, and Clinical Supply.
• Assist with clinical study documentation, TMF maintenance, study start-up activities, and project-related presentations.
• Apply sound judgment, flexibility, and problem-solving skills while managing projects of moderate to high complexity.

Required Qualifications

• Bachelor’s degree in a health-related profession, life science, or related scientific discipline; advanced degree preferred.
• At least 3 years of ongoing clinical trial experience.
• Demonstrated knowledge of Good Clinical Practice (GCP) and FDA regulatory requirements.
• Familiarity with medical terminology.
• Ability to work independently while collaborating effectively with internal teams, clinical sites, and external vendors.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Word, Excel, and Outlook.

If you meet the qualifications and are interested in this Clinical Trials Associate opportunity, apply directly to this job posting. No need to send an email or InMail.