Clinical Research Coordinator II

Department

BSD SRF - cGMP

About the Department

The primary mission of the Cellular and Tissue Based Processing cGMP Facility is to manufacture cell-based products and clinical grade reagents for treatment of patients on Phase I, II and III clinical trials. This core was developed in 2001 to accommodate the growing number of clinical trials that require highly manipulated cellular products for patient treatment. The cGMP facility is registered with the FDA in accordance with 21 CFR part 1271. This registration complies with federal regulations that require clinical facilities engaged in production of cellular products follow strict guidelines to minimize microbial contamination and manufacture cellular-based products that are sterile and potent for their intended purpose. The facility is capable of providing a range of services dedicated for supporting cellular based therapies including vaccines for patient treatments.

Job Summary

The job compiles, documents, analyzes, and reports on moderately complex clinical studies. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University.

The job compiles, documents, analyzes, and reports on clinical research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. Under the supervision of the Technical Director of the cGMP Core, this position requires the candidate to collaborate within a team atmosphere that prepares/process and compound clinical grade vaccines and cell therapy products in the Cellular and Tissue Based Processing cGMP Facility, including tasks related to maintaining the facility operations. This position requires the candidate to adhere to clinical trial protocols and standard operating procedures as well as working off hours at times. The ideal candidate will need to be a self-starter and be responsible for maintaining strict compliance under various regulatory agencies and detailed record keeping. This candidate will be required to juggle multiple/competing priorities and also be assigned back up duties to support facility operations. The candidate must be open to undergoing and pass rigorous training with respect to cGMP and USP standards as well as various technical assays and procedures specific for various cellular manipulation techniques.

Responsibilities

• Perform a variety of cellular product processing procedures under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.

• Perform a variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy.

• Perform a variety of special manufacturing projects under cGMP guidelines as directed with speed and accuracy.

• Provide backup support to a variety of cellular product projects to the Advanced Cellular Therapeutics Facility.

• Transport prepared vaccines/cell therapy products to the clinic or pharmacy.

• Perform various assays including but not limited to CAP proficiency and competency assays as needed for Cell Therapy processes.

• Perform various assays as needed for Cellular Therapy product processes to standard best practices.

• Perform various standard operating procedures as needed for facility operations.

• Assist in the set-up of new equipment and assist with upkeep such as temperature monitoring, daily verification with QC, instrument/operation/performance qualifications (IQ/OQ/PQ), routine maintenance, troubleshooting.

• Support cGMP compliance through validation and qualification of processes, material and supplies, equipment and facility processes, perform vendor qualification of manufacturing supplies and material.

• Ensure all materials and samples are stored correctly at the right temperature.

• Help monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.

• Assist in instrumentation error reports and deviations.

• Perform room change-over in facility after campaigns with specialized cleaning to maintain cGMP compliance.

• Attend all required training and comply with all safety and operations procedures.

• Perform all other duties as requested by the Technical Director or QA/QC Manager.

• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.

• Solves a range of straightforward problems relat