Team Lead, Clinical Trials Specimen Management

Job Title: Team Lead, Clinical Trials Specimen Management

Department: Specimen Processing

Location: Rochester, NY

Hours Per Week: 40

Schedule: Tuesday - Saturday; 8:00AM - 4:30PM

Summary

The Clinical Trials Specimen Management Team Lead supports the supervisor in overseeing, directing and assigning staff to work within Specimen Management. The Team Lead will help with training, inventory, compliance, and quality assurance. The Team Lead will be responsible for supporting departmental metrics, equipment monitoring and process improvements.

Responsibilities

• Oversees the daily management of incoming specimens and delegates specimen management tasks to department processors
• Performs Specimen Management processes at a high level of quality
• Responsible for all bench-work laboratory tasks as assigned by the department Supervisor and/or Manager
• Meet defined turnaround times and metrics set by department, escalate issues and roadblocks, and collects data required for Quality Assurance monitoring.
• Support freezer monitoring, during regularly scheduled hours
• Collects data required for Quality Assurance monitoring and audits
• Collects metrics for departmental volumes and turnaround times
• Communicates and trains employees on compliance procedures and policy requirements
• Assist in the review and provide feedback on study documentation including, freezerworks for new studies, GLSDs, New study requisition forms, and study protocols on behalf of CTSM to support optimal set up and running of clinical trials studies
• Works with Supervisors to monitors inventory and ordering of departmental supplies communicates reorder needs as necessary
• Investigates departmental “Quality Events” and “Clinical Trials Actions or Action Items”; Suggests and implements corrective action as needed
• Participates in meetings and discussions when requested by departmental management
• Communicates and trains employees on compliance procedures and policy requirements
• Is responsible for follow up on pending actions on pending log
• Participates with departmental management in the initial and ongoing training of employees.
• Provide feedback to supervisor on employee performance and training opportunities
• Assist in the monitoring and updating of SOP’s
• Act as a mentor and trainer for more junior staff
• Back up to Supervisor, Specimen Management as necessary
• Courier samples between buildings 150 & 160, as needed
• Act as a point of contact for more complex specimen management related inquiries
• Responsible for reviewing and initiating updates to the departmental Procedure Manual in compliance with ACM, New York State, FDA and federal OSHA and client specifications
• Support the management of ad-hoc process improvements/ remediation projects as required
• Maintain positive working relationships with internal customers
• Perform other duties as assigned
  
  

Required Qualifications

• 6+ months specimen processing experience
  
  

Preferred Qualifications

• Associates or Bachelor Degree in science preferred
• Driver’s License
• Fully trained and competent in all tasks within specialized area (shipping, routine, storage)
  
  

Education

LICENSES / CERTIFICATIONS:

Physical Requirements

M - Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects; Requires frequent walking, standing or squatting.

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

Pay Range

$23.75 - $26.00

City

Rochester

Postal Code

14624

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer.

Minority/Female/Disability/Veterans by a prospective employee and/or employee’s Physician or delegate will be considered for accommodations.