Contract, Research Associate II, Translational Biology - Columbus, OH

Orbis Clinical is seeking a Contract, Research Associate II, Translational Biology located in Columbus, OH for 12 months.

Job Title: Contract, Research Associate II, Translational Biology

Location: Columbus, OH

Contract: 12 months

Job Summary:

Seeking a motivated Research Associate II with experience working in a GCP/GLP environment for a clinical research support role. The team member will collaborate with both internal and external parties in assisting with the execution and management of sample logistics and day-to-day operations including sample preparation and document harmonization as well as document review and upload into a central database. The team member will support the needs of domestic and international biopsy surgical and laboratory sites, distribution of training materials related to sample management and maintain training documentation records. Additionally, they will maintain a site and sample tracking database system to track samples of multiple matrices. This team member will assist with vendor management for specialty lab vendors, associated budget projections and forecasting. The Research Associate II will work closely with the Laboratory Operations and Sample Management teams on tracking and reconciling incoming sample shipments across various clinical and pre-clinical studies.

Primary Responsibilities Include:

Provide support for translational biology efforts in support of Gene Therapy, RNA, siRNA and Gene Editing programs.

Facilitate sample logistics and assist with clinical sample reconciliation efforts including paper and electronic record keeping.

Organize and harmonize clinical sample documentation.

Manage and oversee sample management process development and implementation of centralized database for clinical samples and consent tracking.

Sample and database management.

Assist with coordination and tracking of clinical trial supplies.

Ensure compliance with GCP/ GLP guidelines.

Maintain training manuals and resources for clinical trial biopsy sites.

Assist in the review, editing, and uploading of documents to a central database.

Collaborate with Clinical Operations, Data Management, Biostatistics and vendors for data transfer and analysis needs.

Support communications and build relationships with key stakeholders including CROs, vendors and external collaborators.

Assist laboratory teams with writing and reviewing SOPs, reports and publications related to clinical analyses.

Assist with tracking of departmental metrics as applicable.

Desired Education and Skills:

B.S. degree in Biology, Biochemistry, or related field and 3+ years hands-on clinical sample management or clinical research operations experience in biotech or healthcare setting working in a GCP/GLP environment.

Ability to exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks

Strong organizational skills are required, as well as the ability to balance changing priorities

Demonstrated technical proficiency and quality of sample handling with strict adherence to laboratory SOPs

Track record of solid teamwork and collaboration

Desire to work in a dynamic, fast-paced team environment and to make a difference in the lives of people through our innovative medicines

Demonstrates the ability to communicate clearly across multiple parties, problem solve complex issues, and develop new training material and/or procedures

Excellent technical writing and communication skills; able to articulate complex technical concepts to diverse functional groups and external stakeholders.

This position will require on-site activities.

Compensation Details:

Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.

The Pay Range for this position is $25.80 - $37.93 per hour, can vary depending on employment status.

Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.