Job Title: MRO Assistant Department: Client Services Location: Remote Hours Per Week: 40 Schedule: Monday - Friday; 9:00 AM - 5:00 PM Summary The Medical Review Officer (MRO) Assistant is responsible for the preparation and processing of drug test result files requiring review by the MRO. This includes extensive contact with collection sites, testing laboratories, physicians and clients to ensure timely turnaround of all results. Responsibilities Receive results from laboratories, resolve ‘exceptions’ incompliance with 49 CFR Part 40, provide administrative review for MRO of all negative results, and post to DSI website. Maintain Federal Motor Carrier Safety Administration clearinghouse in compliance with 49 CFR Part 382 Subpart G reporting and recording results as required. Review all related documentation, highlighting compliance elements before releasing to MRO for review and ruling of non-negative drug test results. Receive and review MRO reports of Donor interviews. Check for accuracy, completeness, and Part 40 compliance before updating Drug test result in customer facing DSI data portal. File all related documentation electronically for retrieval and maintaining for five-year compliance. Contact client’s DER to release positive result(s) prior to posting on DSI web portal. Maintain detailed call log of disposition for defensibility. Coordinate communication with client and donor to call MRO for review of laboratory findings; monitor MRO telephone line for donor calls and document messages. Send Donor Contact Sheet to client for all DOT tests and track receipt of completed documentation. Generate Reconciliation Reports to identify test results not received from labs and to verify MRO overturned results. Update and maintain MRO reported “Refusals to Test” and obtain documentation from collection facilities for all atypical collections and maintain electronic files. Initiate and maintain documentation for donor request for information and/or services such as split specimen requests, levels of detection, grievance information and litigation issues. Maintain file of Safety Sensitive concerns issued and monitor time limit for documentation to be received by MRO. Notify client of any change in employee status and document in call log. Review all CCFs with “Remarks” and resolve or follow up as needed Update client, donor, and data entry information as required. Coordinate Chain of Custody Forms to be separated, dated and signature stamped per DOT regulations. Send required amount each quarter to each MRO for signature. Add location codes in system for client billing. Maintain customer MRO relationships. Support the entire DSI Medical Team by providing back-up support to Client Service Associates, Data Entry, Random Administrator and Manager of Client Services in their absence and in periods of high volume. Remain current on all federal regulatory updates and changes and update SOP as required. Other duties may be assigned. Required Qualifications 2 year degree or combination of education and experience. + years of customer or client service experience working in a highly regulated environment required. Preferred Qualifications Excellent verbal and written communication skills. Ability to understand and comprehend technical language in federal regulations 49 CFR Parts 40 & 382 Completion of MRO Assistant Training Course and MRO Assistant Certification preferred. Breath Alcohol Testing Certification preferred. Urine Drug Collection Certification preferred. Physical Requirements S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 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. Show more Show less
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.
Job Title: Clinical Trials Specimen Management Technician Department: Specimen Processing Location: Rochester, NY Hours Per Week: 40 Schedule: Tuesday - Saturday; 8:00AM - 4:30PM Summary The Clinical Trials Specimen Management Technician I performs the daily operations of specified area within the Clinical Trials Specimen Management (CTSM) Laboratory (routine, shipping, storage). They perform all daily functions in accordance to company policies and procedures. Responsibilities Perform all processes in accordance with SOP’s and appropriate regulatory guidelines Perform receipt, QC checks and onward processing for Clinical Trials specimens Perform accurate data entry into various laboratory information management systems Prepare samples for onward shipment Work with samples under varying temperature conditions including ultra-cold (-80°C) and liquid nitrogen (-196°C) Handle deliveries of packages including lifting and carrying of boxes filled with dry ice Perform housekeeping as required to maintain a clean and tidy working environment including frozen storage unit maintenance and emptying waste ice receptacles Utilize study documentation to aid in problem solving and escalate to senior staff as required Manage specimen related study documentation including preparation for archiving Guarantee client satisfaction by providing exceptional service to internal customers Adapt to changing priorities with guidance from senior team members Perform specimen receipt/accessioning/shipping activities depending on your main area of work (Routine, storage or batched shipping) including but not limited to Routine team: Receive process and accession routine specimens Storage Team: Receive, process, store and accession stored specimen Shipping Team: Prepare stored samples for batched shipment Utilize Environmental monitoring software to monitor all specimen storage units to ensure integrity of all specimens at all times Walk samples between building 150 & 160, as needed Perform other duties as assigned Required Qualifications N/A Preferred Qualifications Bachelor’s Degree in Biology, Biomedical Sciences or related field Experience from laboratory and/or highly regulated environments Strong Microsoft Office and data entry skills Strong attention to detail Works well in group setting as well as individually 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 $16.75 - $18.75 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.
As a Supervisor, Clinical Trials Specimen Management at Rochester Regional Health in Rochester, NY, you will be leading a dedicated team responsible for the timely receipt, processing, storage, and shipping of Clinical Trials client specimens. Your role involves supervising employees" performance, supporting the Clinical Trials Specimen Management (CTSM) process, ensuring department turnaround times (TAT), and promoting regulatory compliance, quality assurance, and continuous improvement of CTSM processes. Your responsibilities will include performing all Specimen Management processes with high quality standards, reporting specimen management metrics to support decision-making, supporting timekeeping and approval in KRONOS, maintaining cold storage units and environmental monitoring systems, and participating in on-call environmental monitoring outside regular hours. You will be expected to demonstrate initiative in professional self-development, actively participate in CTSM leadership group meetings, manage process improvement projects, ensure quality training for staff, and drive daily workflow through task rotation and team meetings. Additionally, you will be responsible for managing CTSM personnel, participating in recruitment and onboarding processes, acting as a mentor and coach to the team, resolving specimen management related issues, and driving process improvement within the CTSM team. Your role will also involve collaborating with stakeholders on study documentation, participating in Quality Audits and inspections, ensuring client satisfaction, and providing exceptional service to meet customer expectations. To be successful in this role, you should have at least 6 months of supervisory or team lead experience, completion of training in IATA shipping practices, and preferably an Associates Degree with a concentration in Biology, Biomedical Sciences, or a related field. Experience in Clinical Trials or Biorepository Sciences, within a laboratory or regulated environment, and strong Microsoft Office and Data Entry skills are preferred. You will be expected to exert physical effort in this role, categorized as Medium Work, including occasional force exertion of 20 to 50 pounds, frequent walking, standing, or squatting. The salary range for this position is $62,000.00 to $68,000.00. Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer, committed to diversity and inclusion in the workplace.,
Job Title: Supervisor, Clinical Trials Specimen Management Department: Specimen Processing Location: Rochester, NY Hours Per Week: 40 Schedule: Monday - Friday; 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 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 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 - $70,000.00 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 Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.
As an MRO Assistant in the Compliance department, your role involves preparing and processing drug test result files for review by the Medical Review Officer (MRO). You will have extensive communication with collection sites, testing laboratories, physicians, and clients to ensure timely delivery of all results. **Key Responsibilities:** - Receive results from laboratories, resolve exceptions in compliance with 49 CFR Part 40, provide administrative review of all negative results for the MRO, and post them to the DSI website. - Maintain the Federal Motor Carrier Safety Administration clearinghouse in compliance with 49 CFR Part 382 Subpart G, reporting, and recording results as required. - Review all related documentation, highlighting compliance elements before releasing them to the MRO for review and ruling of non-negative drug test results. - Receive and review MRO reports of Donor interviews, ensuring accuracy, completeness, and Part 40 compliance before updating Drug test results in the customer-facing DSI data portal. - Contact clients DER to release positive results prior to posting on the DSI web portal and maintain a detailed call log of disposition for defensibility. - Coordinate communication with clients and donors for MRO review of laboratory findings, monitor MRO telephone line for donor calls, and document messages. - Generate Reconciliation Reports to identify test results not received from labs and to verify MRO overturned results. - Update and maintain MRO reported Refusals to Test and obtain documentation from collection facilities for all atypical collections. - Initiate and maintain documentation for donor requests for information and/or services such as split specimen requests, levels of detection, grievance information, and litigation issues. - Review all CCFs with Remarks and resolve or follow up as needed. - Update client, donor, and data entry information as required. - Coordinate Chain of Custody Forms as per DOT regulations. - Add location codes in the system for client billing. - Maintain customer MRO relationships and provide back-up support to various roles within the DSI Medical Team. - Stay informed on federal regulatory updates and changes, updating SOP as required. **Qualifications Required:** - 2-year degree or a combination of education and experience. - Customer or client service experience in a highly regulated environment. **Additional Details:** Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer, providing accommodations for prospective employees or employees with disabilities.,