Job Title: Supervisor, Clinical Trials Specimen Management

Department: Specimen Processing

Location: Rochester, NY

Hours Per Week: 40

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

SUMMARY

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 qualityCollate and report specimen management related metrics to support forecasting and decision-making, and propose strategies for improvement using these metricsResponsible for timekeeping and approval in KRONOSAssists in the maintenance and coordination of the cold storage units and environmental monitoring systems and processes as directed by ManageParticipates in rotating schedule for “on call” environmental monitoring and response outside of regular hoursDemonstrate initiative in professional self-development to improve relevant working knowledge of other ACM Clinical Trials departments and processesActively participate in CTSM leadership group meetings to develop standardization and process excellence within the departmentManage ad-hoc process improvement/remediation projects as required and perform other duties as assignedPerforms duties with a general working knowledge of CAP, FDA, NYSDOH, GCP, ICH and other pertinent regulations, as pertains to central laboratory functionsIs responsible to ensure quality driven training is provided to all staff, monitors proficiency, and performs yearly competency for all assigned staffDrive daily workflow in all CTSM areas through task rotation, daily team meetings, and directing team membersPromote positive working relationships with internal clients including Project Management, Study Support teams, and other key stakeholdersBe responsible for line management of CTSM personnel including performance appraisals and disciplinary processesActively participate in recruitment and onboarding of new team membersAct as a mentor and coach to CTSM teamServe as a  contact for, and act as departmental SME for the resolution of specimen management related issues and queriesParticipates in Quality Issue Investigations and CAPA, performs root cause analysis, and implement corrective actionsDrive process improvement within the CTSM team by supporting operational excellence and process improvements to improve productivity, service, quality, cost savings, policies and proceduresAssist in  the development and review of Standard Operating Procedures and associated trainingActively 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 studiesInteract with internal clients including attending meetings as a departmental SMEParticipate as directed in Quality Audits and inspections as prescribed by departmental policies and regulatory agenciesGuarantee client satisfaction by providing exceptional service through a consistent customer centric approach, a focus on precision delivery, and flexibility to meet customer expectationsBack up for Manager, Specimen Management as necessaryCourier samples between buildings 150-160 as requestedOther duties as assigned by the manager

REQUIRED QUALIFICATIONS

6+ months supervisory or team lead experience is requiredDocumentation 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 field2 + years supervisory or team lead experience, preferredClinical Trials or Biorepository Sciences experienceExperience within laboratory or highly regulated environmentStrong Microsoft Office and Data Entry skills

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:

$62,000.00 - $68,000.00

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.