Job Description

Kelly® Science & Clinical is seeking a Clinical Research Lab Coordinator for a fulltime, contract position with a biotech research site client in Fort Collins, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts .

• No C2C
• Initial contract is for 3 months but will most likely extend and/or convert to perm.
• 40 hours per week

Clinical Research Lab Coordinator (Full-Time/Non-Exempt)

The Clinical Research Lab Coordinator supports the conduct of research in carrying out the lab requirements of each study protocol.

Job Description:

The Research Lab Coordinator is responsible for the following operations, as well as other activities that may be necessary for successful completion of a research trial.

General Responsibilities:

• Maintain the highest levels of professionalism and ethics while presenting a positive attitude to all Research clients

• Follow all SOPs unless superseded by sponsor SOPs

• Ensure that all workspaces are kept neat and clean. Maintain and ensure that all equipment is in clean working order. Report any problems to the Site Managers

• Assist with supply management as directed

Study Start-Up Activities:

• Work with CRC and study team to review lab manuals / package inserts provided per study to determine the appropriate laboratory requirements for study

• Ensure lab kits are ordered, received, inventoried, and stored prior to study start

• Perform re-ordering of all lab supplies as needed per study and in a timely manner

• Ensure all ancillary lab supplies are on hand prior to study start

• Ensure lab manual is available before study start

• Review and train on all contents of lab manuals, flow charts, and any applicable package inserts for CLIA waived tests before study start

Study Conduct:

• Collect, process, store, and package biological specimens for shipment as described in the study protocol, lab manual, study flow charts and any package inserts for CLIA waived tests.

(Packaging / shipping requires IATA certification)

• Confirm and document daily that any onsite laboratory samples are maintained at appropriate temperatures per protocol and lab manual and bring any excursions to the attention of the lead CRC and site manager immediately

• Ensure that all packaged samples are scheduled for pick-up by appropriate courier on the day of the collection as stipulated by protocol and lab manuals. If packages are not picked up deliver packages to appropriate courier same day.

• Print all lab reports and route to the appropriate subject binder for Investigator Signature, as applicable

• Maintain access to lab portals for all studies as applicable, resolving any lab queries in a timely fashion as to not delay results

• File all lab reports in the proper section of the subject binder after Investigator has reviewed and signed, as applicable

• Ensure that any repeat labs or other referrals noted on lab reports are brought to the attention of the CRC

• Record accurate and specific study data in the appropriate source documents

• Maintain adequate record / table of all studies with samples onsite and their specific requirements, making sure that the lab is always aware of what samples are currently being stored onsite at all times.

• Assist CRC in any lab-related study close-out procedures

• Assist with other study-related procedures as assigned and are appropriate by delegation of authority log

• Other duties as assigned

Required Skills/Abilities:

• Excellent phlebotomy skills

• Experience with lab processing (preferred)

• Ability to follow exact instructions

• Some knowledge of OSHA requirements

Education and Experience:

• High School Diploma

• Phlebotomy certification and/or experience preferred

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