Clinical Research Associate I

We are hiring for a Research Associate in the Translational Biology ?department to support clinical research of Gene Therapy products. This is a long-term career opportunity and we are looking for someone with a Bachelors Degree in a science and at least 2+ years of experience with hands-on clinical sample management, or clinical research operations in biotech or a healthcare setting. Ideally will have that experience in a GCP/GLP environment.

Candidates with a PhD level education will be considered overqualified and will most likely not be considered for this role. Ideally a candidate will have a Bachelors or Masters and relevant experience as noted above.

INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA AT 330. 397. 1302 TO SET UP AN IMMEDIATE PHONE INTERVIEW!

Job Description

This Research Associate I role in Translational Biology focuses on clinical research support in a GCP/GLP environment, with a strong emphasis on clinical sample management, sample logistics, and coordination across internal teams and external partners. The position supports translational biology efforts for advanced therapeutic programs, including cell and gene therapy, and involves managing clinical and pre-clinical samples, maintaining documentation and databases, and contributing to high-quality laboratory operations and data integrity.

Responsibilities

• Provide research and operational support for translational biology efforts across cell and gene therapy, RNA, siRNA, and gene editing programs.

• Facilitate clinical sample logistics and support clinical sample reconciliation, ensuring accurate paper and electronic record keeping.

• Manage and oversee the clinical sample management process, including the development and implementation of a centralized database for clinical samples and consent tracking.

• Perform day-to-day sample and database management, ensuring data accuracy, completeness, and traceability.

• Assist with coordination, distribution, and tracking of clinical trial supplies to domestic and international biopsy, surgical, and laboratory sites.

• Ensure compliance with GCP and GLP guidelines, as well as FDA regulations and ICH guidelines, in all aspects of sample handling and documentation.

• Maintain training manuals, materials, and resources for clinical trial biopsy sites, and support distribution of training materials related to sample management.

• Collaborate closely with Clinical Operations, Data Management, Biostatistics, and external vendors to support data transfer and analysis needs.

• Support communications and build productive relationships with key stakeholders, including CROs, specialty laboratory vendors, and external collaborators.

• Work with Laboratory Operations and Sample Management teams to track and reconcile incoming sample shipments across various clinical and pre-clinical studies.

• Assist laboratory teams in writing, reviewing, and updating SOPs, reports, and publications related to clinical analyses.

• Assist with tracking and reporting departmental metrics as applicable, contributing to continuous improvement of processes.

• Exercise discretion and sound judgment in handling confidential information and ensure strict adherence to all relevant regulatory and quality standards.

• Contribute to a collaborative, fast-paced team environment and actively participate in problem solving and process optimization.

Qualifications

• Bachelor's degree in Biology, Biochemistry, or a related field.

• At least 2 years of hands-on clinical sample management or clinical research operations experience in a biotech or healthcare setting.

• Demonstrated experience working in a GCP/GLP environment.

Job Type & Location

This is a Contract position based out of Columbus, OH.

Pay and Benefits

The pay range for this position is $25.00 - $27.00/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 fully onsite position in Columbus,OH.

Application Deadline

This position is anticipated to close on Jun 8, 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 process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.