Lahey Hospital & Medical Center is part of a vibrant and growing health care system, recognized as a trailblazer in medicine and a standard bearer in patient experience. It includes an award-winning academic medical center, a superb constellation of community hospitals, home care services, rehabilitation facilities and more.
We are committed to attracting, developing and retaining top talent in a market long recognized and revered as a global leader in health. With a team approach to care, we encourage learning and growth at all levels, and we offer competitive salaries and benefits. We adhere to the principles of a just and fair work environment for all colleagues, where respect is foundational and performance is rewarded.
About the Job
Position Summary: Under the general supervision and direction of Research Coordinator, will be responsible for coordinating research studies for the CRA. He/she will also be responsible for generating reports and statistical information relating to these assigned research studies, as well as general research administration duties. He or she will also provide a variety of support to the professional and support staff of the Lahey Clinic in the conduct of Clinical Trials.
Essential Duties & Responsibilities including but not limited to:
- Coordinating Research Trials:
- Implements assigned research studies at Lahey Clinic.
- Reviews assigned research study and assesses institutional requirements.
- Establishes procedures with the necessary departments for processing the study requirements. For example, arranges special blood draws with phlebotomy, special blood processing with specimen processing, ordering and receiving of drug with the pharmacy, copying and submission of x-rays with Radiology, retrieval and submission of pathology samples with Pathology, etc.
- Prepares internal "paper" checklists/tracking systems to monitor the conduct of the study.
- Programs automated computer systems to conduct the study or uses established department systems. For example, automated data entry system which prints internal letters required upon entry of a patient on study.
- Conducts Inservices to departments in which special procedures have been set up to conduct the study at Lahey Clinc.
- Submits study to Research Office for review by the Institutional Review Board (IRB).
- Completes Research Office forms for the review of the study by the IRB.
- Conducts assigned research studies at Lahey Clinic.
- Advises physicians on required tests, timing of tests, procedures to be followed with suspicious test results, etc. Assures that all appropriate treating physicians receive the results of study tests, as appropriate.
- Utilizes Lahey Clinic's mainframe computer to schedule tests and appointments, and to access patient data and test results.
- Acquires detailed knowledge of assigned studies so as to serve as a specialist for the assigned research study and triage calls from the physicians and support staff. Contacts the sponsor when unsure of the answers to any of the calls being triaged.
- Establishes monitoring tools to ensure the adherence to study guidelines. For example, monthly drug audits to ensure proper receipt, logging and dispensing of drug according to NCI guidelines.
- Completion of yearly progress reports for submission to and review by the IRB, Submission of amendments and all other regulatory documentation requiring review by the IRB.
- Performs Data Management duties.
- Evaluates patient data to determine if patient meets study eligibility and registers or randomizes the patients to assigned research study.
- Completes Case Report Forms (CRFs) as dictated by the assigned research study (i.e., required forms in the required format in the required time interval). Provides source documentation from the medical chart for all information that is recorded.
- Submits CRFs to the sponsor as dictated by the study. Maintains sufficient files in the department to document submission and maintain source documentation.
- Schedules sponsor audits, as requested, and is available during audit to review CRFs and procedures with sponsor personnel, as necessary. Responds to sponsor requests for additional material, clarifying material or missing material. Works cooperatively with sponsor to ensure that good clinical practice are being followed.
- Directly retrieves or coordinates the retrieval and submission of patient samples (i.e., blood, tissue, radiology films, etc.)
- Recruits patients to assigned research studies at Lahey Clinic.
- Works closely with physicians to develop recruitment strategies.
- Identifies eligible patients through many means (i.e., reviews pathology reports in specific disease categories, reviews consultation request logs review reasons for patient visits).
- Approaches and assists in other research project as assigned.
- Designs abstraction forms for purposes of medical chart abstraction.
- Abstracts medical records to gather data for assigned research projects.
- Uses Lahey Clinic's Mainframe Computer to gather test results for data entry for assigned research projects.
Education and Training: College desirable or work equivalent. Strong organizational and communication skills. Ability to function independently and to devise creative ways of obtaining information. Knowledge of medical terminology and medical practice. Ability to interact with professional personnel at all levels. Knowledge of computer databases. Knowledge of computer word processing systems.
Licensure, Certification, Registration:
Skills, Knowledge & Abilities: Strong orginizational and communication skill, ability to function independtly and to devise creative ways of obtaining information, knowledge of medical terminology and medical practice, ability to interact with professional personnel at all levels, knowledge of computer databases and knowledge of computer word processing systems. In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.
Experience: At least six months clinical/hospital operations experience. Can demonstrate the following experience: Report preparation; able to locate, organize and prepare medically related information for study purposes.
The Lahey Model of Care—right care, right time, right place—is exactly what patients, providers and payers need and deserve. Identifying and delivering on this convergence of interests has positioned Lahey Health for further growth. Our model ensures care is highly coordinated and locally delivered, with lower costs and exceptional quality.
Lahey Health is a robust, regional system including a teaching hospital, community hospitals, primary care providers, specialists, behavioral and home health services, skilled nursing and rehabilitation facilities, and senior care resources throughout northeastern Massachusetts and southern New Hampshire. The system has a global presence with programs in Canada, Jordan and Bermuda.
Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.