Manager, Research Tissue

OneOncology•Nashville, TN

About The Position

This management position will play an essential role in providing technical support and expertise to the Research Lab and Clinical Trial Specialists in the preparation and procurement of human research materials in coordination with appropriate clinical trials and research studies. This position will be responsible for overseeing the collection, processing, storage, and distribution of tissue samples for research purposes and will adhere to Tennessee Oncology mission, vision, and values.

Requirements

Ability to make independent decisions, process information accurately, manage multiple projects simultaneously and be organized.
Ability to communicate with a diverse group of individuals with various degrees of training and education.
Knowledge of FDA Code of Federal Regulation and GCP.
High level of customer service ethics with courteous demeanor and the ability to process inquiries and respond with poise and efficacy.
Ability to recognize, evaluate and solve problems.
Ability to accurately pipette and maintain sterile conditions as required.
Strong computer skills especially with Excel and Word spreadsheets.
Bachelor’s degree in health or science related field required
Valid Driver’s License required.
Minimum of 3 years’ relevant experience

Nice To Haves

Two years of supervisory experience preferred.
Certification in clinical research coordination from ACRP or SOCRA preferred.

Responsibilities

Administrative Assignments Review proposed protocols for feasibility.
If necessary, create and implement new processes to accommodate feasibility questionnaires or sponsor guidelines.
Gather information pertaining to tissue from new protocols and documents into appropriate study review assignments.
Create appropriate SOPs and training documents pertaining to processes in order to satisfy sponsor protocol specifications.
Attends sponsor Site Initiation Visits to review any tissue requirements for our site locations.
Assist with reviewing protocol and internal budgets.
Oversees the scheduling of fresh tissue biopsies in accordance with protocol specifics and will coordinate with the processing lab for collection, processing, and shipment of specimens.
Continuously monitors and updates the tissue tracking grid to keep the research team aware of patient’s specimen status.
Scheduling and payroll of Research tissue team.
Processing Human Biological Specimens May serve as an assistant to investigator during dissections or surgery.
Oversees research support of tissue collection, processing and specimen distribution for research studies and clinical trials in outpatient clinics.
Maintains laboratory and surgical areas with proper aseptic techniques.
Will require travel to location where specimen is being collected to obtain specimens from various sites in. Travel mileage to be reimbursed with properly filled out expense form.
Label, receive and process samples (blood, urine, tissue etc.) for clinical trials per specific protocol guidelines to include logging samples into and out of the department.
Data and Outside Specimen Management Request, receive and return tissue samples from outside pathology facilities.
Send tissue blocks to vendor to have slides cut and ship slides to the appropriate study’s lab.
Record all data in specified forms per clinical trial, both written and electronic, with accuracy and responsibility.
Maintain clear and accurate records, both written and electronic, of laboratory data. Data must be readily accessible by Research Laboratory Manager
Laboratory Operations: Ship or store samples as per protocol before the end of the shift.
Carry out lab duties that include purchasing, organization, compliance and lab safety.
Manage inventory of clinical trials supplies and kits as well as departmental supplies so that workflow is not negatively affected.
Participates and contributes to institutional and external compliance efforts necessary for the clinical trials and laboratory processes.
Communicate with Clinical Trials Specialists (CTSs), Research Laboratory Manager, or clinical staff on any questions prior to specimen collection.
Assist in training new team members in the collection, procurement, receipt, and distribution of research tissue samples.
Other duties as assigned.