Molecular Diagnostics Coordinator - Pathology Lab

HHC•Indianapolis, IN

About The Position

The Molecular Diagnostics Coordinator provides direct assistance to the Manager and Section Pathologist by being the primary resource for technical expertise and operations of molecular diagnostic development, modeling a commitment to providing exemplary care in laboratory testing and customer service. The Molecular Diagnostics Coordinator is responsible for providing technical oversight and quality control over all validations and verifications in the Division of Clinical Microbiology & Serology, playing a proactive role in improving good clinical practice (GCP), good document practice (GDP), QA/QC review, while being available to others for help and information in problem solving and troubleshooting. In addition to the roles described above, the Molecular Diagnostics Coordinator also performs all the functions of a Medical Technologist.

Requirements

Bachelor’s degree in Medical Technology/Clinical Laboratory Science or related science (e.g. Biology or Chemistry) from an accredited U.S. college or university; foreign degrees must be officially assessed to determine U.S. equivalency
ASCP or equivalent certification
Minimum 5 years’ experience in high complexity laboratory testing with molecular assays is required
Strong knowledge of CLIA and CAP regulations related to Microbiology, Immunology, and Molecular Pathology
Extensive experience with the development of laboratory-developed tests, molecular validations, and verifications
Thorough knowledge of molecular diagnostics, clinical microbiology, serology, and infectious disease testing principles and workflows
Working knowledge of CLIA, CAP, ACGME, and other applicable regulatory and accreditation requirements
Demonstrated ability to design, execute, and document assay validations, verifications, and performance studies
Strong quality management skills, including QC/QA monitoring, trend analysis, root cause analysis, and corrective and preventive action (CAPA)
Proficiency in developing, reviewing, and maintaining SOPs, IQCPs, competency assessments, and training documentation
Ability to coordinate and deliver clinical education for fellows, residents, and MLS students across multiple laboratory sections
Strong organizational and time-management skills, with the ability to prioritize tasks and meet regulatory deadlines in a high-throughput environment
Effective communication skills for interacting with laboratory staff, trainees, clinicians, vendors, and leadership
Ability to troubleshoot molecular instrumentation, assays, and workflow issues and escalate concerns appropriately
Proficiency with EPIC Beaker, data review, and report validation
Demonstrated leadership skills, including staff support, mentorship, and decision-making in the absence of laboratory management
Ability to work independently and collaboratively, including availability for consultative support as required

Responsibilities

Follows policies and procedures (SOPs) to ensure minimal errors during all phases of testing as defined in the Medical Technologist job description
Responsible for technical oversight and quality control of validations, verifications, and implementation of new molecular testing assays; monitors quality control and quality assurance in Microbiology, Serology, and Molecular Infectious Disease Testing
Assists with schedules, managing PTO requests, competency assessments, new employee orientation and training, writing and providing input into section-specific SOPs and IQCPs as manager requests
Ensures that proficiency testing is assigned and ordered, completed in a timely manner, and accurately reported; if there are deficiencies, ensures that the investigation is completed and documented according to SOPs
Act as a clinical education coordinator: Instructor for CPEP Clinical Microbiology Fellows, scheduling Pathology Residents, ACGME Fellows, and MLS students for their clinical rotations through microbiology, serology, and molecular infectious disease testing, and keeping training materials up-to-date
Responsible for inventory and ordering supplies, maintenance of instruments and equipment (may include instrument comparisons, linearities, etc.), monitoring quality control, and following up with any issues
Completes assignments/mandatories according to policies and procedures, with complete documentation and within designated time frames, including, but not limited to: policy and procedure reviews, read and signs, annual TB testing and flu shots, section competencies, proficiency testing, Eskenazi Health annual education
Assists manager in change requests and EPIC builds, checking final results, providing reports in Epic, giving input for employees’ performance appraisals, helping interview job applicants, and filling in for department specific meetings as needed
Assumes supervisory responsibilities in the absence of the manager/section pathologist; must be available to staff and providers for consults outside of work (24/7) in coordination with the manager and section pathologist; ensures lab is both inspection ready and prepared for any downtime that may occur
Performs other job-related duties as assigned