The Supervisor, Clinical Trials Specimen Management (CTSM) supervises a team dedicated to the timely receipt, processing, storage and shipping of Clinical Trials client specimens. The supervisor monitors employees' performance, supports the CTSM process and ensures department turnaround times (TAT). The supervisor is also responsible for supporting regulatory compliance, quality assurance/performance improvement, and continuous improvement of CTSM processes.
RESPONSIBILITIES
Perform all Specimen Management processes to a high level of quality
Collate and report specimen management related metrics to support forecasting and decision-making, and propose strategies for improvement using these metrics
Responsible for timekeeping and approval in KRONOS
Assists in the maintenance and coordination of the cold storage units and environmental monitoring systems and processes as directed by Manage
Participates in rotating schedule for "on call" environmental monitoring and response outside of regular hours
Demonstrate initiative in professional self-development to improve relevant working knowledge of other ACM Clinical Trials departments and processes
Actively participate in CTSM leadership group meetings to develop standardization and process excellence within the department
Manage ad-hoc process improvement/remediation projects as required and perform other duties as assigned
Performs duties with a general working knowledge of CAP, FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functions
Is responsible to ensure quality driven training is provided to all staff, monitors proficiency, and performs yearly competency for all assigned staff
Drive daily workflow in all CTSM areas through task rotation, daily team meetings, and directing team members
Promote positive working relationships with internal clients including Project Management, Study Support teams, and other key stakeholders
Be responsible for line management of CTSM personnel including performance appraisals and disciplinary processes
Actively participate in recruitment and onboarding of new team members
Act as a mentor and coach to CTSM team
Serve as a contact for, and act as departmental SME for the resolution of specimen management related issues and queries
Participates in Quality Issue Investigations and CAPA, performs root cause analysis, and implement corrective actions
Drive process improvement within the CTSM team by supporting operational excellence and process improvements to improve productivity, service, quality, cost savings, policies and procedures
Assist in the development and review of Standard Operating Procedures and associated training
Actively work with appropriate stakeholders on the generation of study documentation including GLSDs, requisition forms, and study protocols on behalf of CTSM to support optimal set up and running of clinical trials studies
Interact with internal clients including attending meetings as a departmental SME
Participate as directed in Quality Audits and inspections as prescribed by departmental policies and regulatory agencies
Guarantee client satisfaction by providing exceptional service through a consistent customer centric approach, a focus on precision delivery, and flexibility to meet customer expectations
Back up for Manager, Specimen Management as necessary
Courier samples between buildings 150-160 as requested
Other duties as assigned by the manager
REQUIRED QUALIFICATIONS
6+ months supervisory or team lead experience is required
Documentation of completion in training of IATA shipping practices within 30 days of hire
PREFERRED QUALIFICATIONS
Associates Degree with concentration in Biology, Biomedical Sciences or related field
2 + years supervisory or team lead experience, preferred
Clinical Trials or Biorepository Sciences experience
Experience within laboratory or highly regulated environment
Strong Microsoft Office and Data Entry skills
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.
PAY RANGE: $62,000.00 - $68,000.00
The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. 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/Veteran
