Mid-Level Clinical Research Laboratory Manager

Mid-Level Clinical Research Laboratory Manager

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Mid-Level Clinical Research Laboratory Manager

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Job Summary:

CenExel is a respected organization specializing in Phase I to IV clinical trials across various medical fields. They are seeking a Clinical Research Laboratory Manager to oversee lab operations, ensure compliance, and manage lab personnel while maintaining high-quality standards in testing and safety protocols.

Responsibilities:

• Ensures all lab processes for studies are carried out properly and accurately by the lab team.

• Ensures all tracking systems are adhered to and all protocol required lab procedures are carried out appropriately.

• Makes appropriate staffing assignments, ensuring delegated tasks are within an employee’s scope of practice.

• Responsible for the day-to-day operations of the medical testing laboratory.

• Ensures the quality and accuracy of test results.

• Oversees the inventory, maintenance, and validation of laboratory equipment.

• Performs regular inventory of supplies and orders as needed to ensure the lab supplies are adequate and available for study visits.

• Develops and implements procedures to ensure the safety and security of the laboratory.

• Reads and understands protocol requirements for blood specimens including blood collection, labeling of samples, processing samples, storage of samples and shipping of samples.

• Notifies the appropriate lab that the shipment has been sent, including the protocol number, site number and PI's name. Communicates required shipment information including protocol number, site number, PI's name, etc. Acts as a contact point for outside inquiries.

• Ensures storage and tracking system is set up prior to starting the study, with a method of storing the samples in appropriate containers. Primary and back-up samples are stored independent of each other.

• Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.

• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Qualifications:

Required:

• Must be a high school graduate or have GED equivalency.

• Must have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc.

• Must be self-motivated, organized and able to perform tasks independently.

• Must be able to effectively communicate verbally and in writing.

Preferred:

• Phlebotomist certification preferred.

Company:

CenExel is a clinical research site network supporting phase I-IV clinical trials. It is a sub-organization of Webster Equity Partners. Founded in 2018, the company is headquartered in Salt Lake City, Utah, USA, with a team of employees. The company is currently Late Stage. CenExel has a track record of offering H1B sponsorships.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Product Management

• Industries

  Software Development

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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