Research Associate II

Actalent; Columbus (OH); Presencial; USD 39 000 - 47 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave

Resumo da oferta

Actalent in Columbus, OH is seeking Research Associate I and II to join a fast-paced biologics and gene therapy environment. The roles focus on clinical sample management, documentation, and support for translational biology programs in a GCP/GLP setting.

You will collaborate with Clinical Operations, Data Management, and external partners to track samples, manage biospecimens, maintain databases, and ensure compliance across studies.

Qualificações

• Experience in clinical sample management within a biotech/healthcare setting.
• Familiarity with GCP/GLP environments and regulatory standards.
• Strong written and verbal communication for cross-functional collaboration.

Responsabilidades

• Support translational biology efforts for RNA, siRNA, gene therapy, and genome editing.
• Organize and maintain clinical sample documentation across studies.
• Develop and implement a centralized database for samples and consent tracking.
• Ensure adherence to GCP/GLP guidelines and quality standards.
• Collaborate with Clinical Operations, Data Management, Biostatistics, and CROs.

Conhecimentos

Clinical sample management

GCP/GLP compliance

Documentation & data entry

Cross-functional teamwork

Scientific writing

Formação académica

B.S. in Biology or related field

Descrição da oferta de emprego

Research Associate I and II

We are currently hiring multiple Research Associate I and II roles in Columbus. These are 1st shift positions and will be supporting a biologics/cell & gene therapy company.

The Research Associate II provides critical clinical research support within a GCP/GLP environment, focusing on clinical sample management, logistics, and documentation for translational biology programs. This role collaborates closely with internal teams and external partners to manage biopsy and laboratory site needs, oversee sample tracking across multiple studies, and maintain centralized databases and training records. The position plays a key role in supporting RNA, siRNA, gene therapy, and genome editing programs by ensuring high-quality sample handling, accurate documentation, and compliant operations in a dynamic, fast-paced setting.

Responsibilities

• Support translational biology efforts for RNA, siRNA, gene therapy, and genome editing programs by ensuring accurate and compliant clinical sample management.
• Facilitate sample logistics and assist with clinical sample reconciliation, including both paper-based and electronic record keeping.
• Organize, harmonize, and maintain clinical sample documentation to ensure consistency and completeness across studies.
• Manage and oversee the sample management process, including development and implementation of a centralized database for clinical samples and consent tracking.
• Perform data entry, tracking, and database management related to clinical samples and associated documentation.
• Assist with coordination and tracking of clinical trial supplies to ensure timely availability for biopsy and laboratory sites.
• Ensure adherence to GCP and GLP guidelines in all aspects of clinical sample handling, documentation, and operations.
• Maintain training manuals, resources, and documentation records for clinical trial biopsy and laboratory sites.
• Review, edit, and upload clinical and operational documents into a central database, ensuring accuracy and version control.
• Collaborate 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 contract research organizations, vendors, and external collaborators.
• Assist laboratory teams with writing and reviewing standard operating procedures (SOPs), reports, and publications related to clinical analyses.
• Contribute to the tracking and reporting of departmental metrics, helping to monitor performance and operational efficiency.
• Assist with vendor management for specialty laboratory vendors, including support for budget projections and forecasting related to sample management activities.
• Work closely with Laboratory Operations and Sample Management teams to track and reconcile incoming sample shipments across clinical and pre-clinical studies.

Essential Skills

• B.S. degree in Biology, Biochemistry, or a related field.
• At least 1-3 years of hands‑on clinical sample management or clinical research operations experience in a biotech or healthcare setting.
• Experience working in a GCP/GLP environment with strict adherence to regulatory and quality standards.
• Ability to exercise discretion and judgment in handling confidential information while following FDA regulations, ICH guidelines, and GCP in all tasks.
• Strong organizational skills with the ability to balance changing priorities and manage multiple concurrent activities.
• Demonstrated technical proficiency and high‑quality sample handling with strict adherence to laboratory SOPs.
• Proven track record of effective teamwork and collaboration across multidisciplinary groups.
• Ability and desire to work in a dynamic, fast‑paced team environment focused on advancing innovative medicines.
• Demonstrated ability to communicate clearly with multiple parties, solve complex issues, and develop new training materials and procedures.
• Excellent technical writing and communication skills, with the ability to articulate complex technical concepts to diverse functional groups and external stakeholders.
• Hands‑on experience with biology, virology, PCR, and molecular biology techniques.
• Experience with RNA‑related work and gene therapy approaches, including AAV‑based methods.
• Comfort working in an animal research environment and following appropriate procedures and standards.
• Willingness and ability to perform on‑site activities as required.

Additional Skills & Qualifications

• Experience supporting translational biology programs involving RNA, siRNA, gene therapy, and genome editing.
• Familiarity with clinical trial supply management and logistics for biopsy and laboratory sites.
• Experience maintaining and using centralized databases for clinical samples, consent tracking, and documentation.
• Ability to develop, maintain, and improve training manuals and resources for clinical and laboratory sites.
• Experience collaborating with Clinical Operations, Data Management, Biostatistics, CROs, and specialty laboratory vendors.
• Background in writing and reviewing SOPs, technical reports, and publications related to clinical analyses.
• Strong problem-solving skills, with the ability to address complex operational and data-related issues.
• Motivation to contribute to innovative therapies that aim to improve patients lives.
• Comfort working in a growing, state‑of‑the‑art cell and gene therapy manufacturing environment.

Work Environment

Work Environment This position is primarily based in a laboratory environment within a new, state‑of‑the‑art facility focused on cell and gene therapy manufacturing. The Research Associate II will spend most of the day working in an animal research setting, handling samples and performing laboratory‑related activities that require adherence to GCP/GLP and laboratory SOPs. Some time will be spent at a desk performing documentation, data entry, database management, and communication with internal teams and external partners. The environment is dynamic and fast‑paced, with close collaboration across scientific, clinical, and operational groups, offering the opportunity to contribute to cutting‑edge gene therapy and translational biology programs.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $28.00 - $34.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors. 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.

• 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)

Application Deadline

This position is anticipated to close on Oct 26, 2026.

Workplace Type

This is a fully onsite position in Columbus,OH.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News‑Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [e-mail] 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)

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