Clinical Research Laboratory Manager

Clinical & Support Options Inc; Englewood (CO); On-site; USD 79,000 - 100,000; Full time

Job summary

CenExel Clinical Research in Englewood, CO seeks a Lab Operations Manager to oversee all lab areas and personnel, ensuring study completion and adherence to procedures. You will supervise daily lab activities, maintain safety, and ensure test quality and equipment integrity in a fast-paced clinical research environment.

Responsibilities include staffing, compliance with FDA/ICH/GCP, and coordinating with sponsors to deliver accurate results, while maintaining an emphasis on teamwork and

Qualifications

• Must have high school diploma or GED.
• Experience processing samples.
• Experience supervising lab technicians.
• Good interpersonal skills.
• Effective communication in writing and speaking.

Responsibilities

• Ensure all lab processes for studies are carried out properly and accurately by the lab team.
• Oversee tracking systems and ensure protocol-required lab procedures are followed.
• Staffing assignments within each employee's scope of practice.
• Manage day-to-day operations of the medical testing laboratory.
• Ensure the quality and accuracy of test results.
• Oversee inventory, maintenance, and validation of lab equipment.
• Develop and implement procedures to ensure safety and security of the laboratory.
• Read and interpret protocol requirements for blood specimens, labeling, processing, storage, and shipping.
• Notify shipment details to the appropriate lab and act as contact for inquiries.
• Ensure storage/tracking systems before starting studies, with independent primary/back-up samples.
• Hire, train, supervise, and evaluate personnel; enforce FDA, ICH, GCP, CenExel SOPs.

Skills

Interpersonal skills

Supervising lab staff

Verbal & written communication

Education

High School Diploma or GED

Job description

Description

About Us:

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

Manages all lab areas and personnel by overseeing daily operational and technical functions with a focus on project completion and resource management. Responsible for ensuring compliance with policies and procedures. Other responsibilities include supervising daily responsibilities of lab personnel, safety of participants, and study conduct.

Compensation

$78,642 - $100,000 annually depending on experience, education, and skillset.

Essential Responsibilities and Duties:

• 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.

Education/Experience/Skills:

• Must be a high school graduate or have GED equivalency.
• Must have experience processing samples.
• Must have experience supervising lab technicians.
• 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.

Working Conditions

• Indoor, Clinic environment.
• Essential physical requirements include sitting, typing, standing, and walking.
• Lightly active position, occasional lifting of up to 20 pounds.
• Reporting to work, as scheduled, is essential.
• This is an on-site work arrangement.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.