Research Associate, Clinical Research

Position: URGENTLY HIRING: Research Associate I
Research associate i

Interested candidates can send updated resumes to mamcdonough @actalentservices .com or text marisa . 1302 to set up an immediate phone interview!

Job description

The research associate i plays a key role in clinical research support within a gcp/glp environment, focusing on sample logistics, preparation, and documentation for clinical and pre-clinical studies. This position collaborates closely with internal teams and external partners to manage biopsy samples, harmonize documents, maintain training records, and oversee a centralized site and sample tracking database. The role supports domestic and international surgical and laboratory sites and contributes to vendor management for specialty laboratories, ensuring accurate tracking and reconciliation of incoming sample shipments across a range of therapeutic programs.

Responsibilities

+ support translational biology efforts across cell and gene therapy, rna, sirna, and gene editing programs by managing clinical and pre-clinical samples.

+ facilitate end-to-end sample logistics, including coordination of shipments, tracking, and reconciliation of clinical samples using both paper and electronic record-keeping systems.

+ develop, manage, and oversee sample management processes, including the implementation and maintenance of a centralized database for clinical samples and consent tracking.

+ perform ongoing sample and database management to ensure data integrity, accuracy, and timely updates for all clinical and pre-clinical studies.

+ assist with coordination, tracking, and inventory oversight of clinical trial supplies to support biopsy surgical and laboratory sites.

+ ensure strict compliance with gcp and glp guidelines, fda regulations, ich guidelines, and applicable sops in all sample handling and documentation activities.

+ maintain, update, and distribute training manuals, materials, and resources related to sample management for clinical trial biopsy sites, and keep training documentation records current.

+ collaborate with clinical operations, data management, biostatistics, and external vendors to support data transfer, data reconciliation, and analysis needs for clinical studies.

+ build and maintain effective communications and strong working relationships with key stakeholders, including contract research organizations (cros), specialty lab vendors, and external collaborators.

+ assist laboratory teams with writing and reviewing standard operating procedures (sops), study reports, and publications related to clinical analyses, ensuring technical accuracy and clarity.

+ support the tracking and reporting of departmental metrics and operational performance indicators, as applicable.

+ exercise discretion and sound judgment in handling confidential information, ensuring compliance with all relevant regulatory and ethical standards.

+ contribute to a collaborative, fast-paced team environment by actively participating in cross-functional projects and problem-solving initiatives.

Essential skills

+ bachelor's degree in biology, biochemistry, or a related scientific field.

+ minimum of 2 years of hands-on clinical sample management or clinical research operations experience in a biotech or healthcare setting.

+ proven experience working in a gcp/glp environment with strict adherence to regulatory and quality standards.

+ strong bg in biology, including familiarity with virology, molecular biology techniques such as pcr, and immunoassays such as elisa.

+ experience with rna and gene therapy-related research and sample handling.

+ demonstrated technical proficiency in sample handling and processing, with consistent adherence to laboratory sops.

+ ability to exercise discretion and judgment in handling confidential and sensitive information.

+ strong organizational skills with the ability to balance changing priorities and manage multiple tasks simultaneously.

+ track record of effective teamwork and collaboration in a cross-functional setting.

+ ability to communicate clearly with multiple parties and stakeholders, both internally and externally.

+ excellent technical writing and communication skills, with the ability to articulate complex technical concepts to diverse functional groups and external stakeholders.

+ demonstrated ability to problem-solve complex issues related to sample management, logistics, and process improvements.

Additional skills & qualifications

+ experience with animal research in a laboratory setting.

+ familiarity with clinical trial operations, including coordination of clinical trial supplies and interactions with biopsy surgical and laboratory sites.

+ experience supporting translational biology activities in cell and gene therapy programs.

+ ability to develop new training materials, procedures, and documentation to support evolving study and operational needs.

+ comfort working in a dynamic, fast-paced environment with a strong desire to contribute to innovative medicines that improve patients' lives.

+ ability to build and maintain…