Welcome to Lahey Hospital & Medical Center, part of Beth Israel Lahey Health. Lahey Hospital & Medical Center is a world-renowned tertiary medical center known for its innovative technology, pioneering medical treatment and leading-edge research. A teaching hospital of Tufts University School of Medicine, the hospital provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation. It is a national leader in a number of health care areas, including stroke, weight management and lung screenings, among many others. Lahey also helps to advance medicine through research and the education of tomorrow's health care leaders.
About the Job
Under the supervision of the Research Administration and in collaboration with the Principle Investigator, Has knowledge of and complies with FDA, DHHS, GCP regulations. Develops new research initiatives in collaboration with Lahey staff and sponsors. The Clinical Research Specialist will assist with study design, data collection, and statistical analysis. Directs the coordination/ implementation of research protocols. Assists in developing appropriate budget for research protocols. As part of their functions as an interdepartmental liaison, evaluating, coordinating, and facilitating diverse clinical research projects conducted by Clinic staff. This individual will function both as a resource person and educator. Responsible for other research staff when applicable.
Essential Duties & Responsibilities including but not limited to:
- Clinical practice evaluations:
- Assists in designing/implementation of phase I-IV pharmaceutical and class I-III device trials. Designs and implements improvement projects based on study results.
- Prepares and submits study applications to the Institutional Review Board and assists in applications for funding.
- Designs data abstraction forms development of computer databases and programs.
- Review patient medical records, laboratory and radiologic data, pharmacy data, operative reports, and other resource utilization data, performs data entry.
- Assists in preparing summary reports and manuscripts for publication.
- Supervises Sr. Clinical Research Associate, Clinical Research Associate and Study Coordinator.
- Conducts assigned research studies:
- Has knowledge of and conducts all research protocols according to FDA/DHHA(OHRP) and GCP regulations and guidance
- 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 protocol. For example, monthly drug audits to ensure proper receipt, logging and dispensing of drug according to NCI guidelines.
- Completion of yearly continuation reports for submission to and review by the IRB, Submission of amendments and all other regulatory documentation requiring review by the IRB.
- Data Management:
- 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 per designated protocol schedule (i.e., required forms, required format in the required time interval). Provides source documentation from the medical record 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 monitor visits, as requested, and is available during monitor visit to review CRFs/ study 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 guidelines are being followed.
- Directly obtains for submission or coordinates the submission of patient samples to the sponsor or appropriate recipient (i.e., blood, tissue, radiology films, etc.)
- Patient recruitment for assigned research studies:
- Works closely with physicians to develop recruitment strategies.
- Identifies eligible patients (i.e., reviews pathology reports in disease specific categories, reviews consultation request logs review reasons for patient visits).
- Assists with 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.
- Participates in Continuing Professional Education.
- Incorporates Lahey Clinic Guiding Principles , Mission Statement and Goals into daily activities.
- Complies with all Lahey Clinic Policies.
- Complies with behavioral expectations of the department and Lahey Clinic.
- Maintains courteous and effective interactions with colleagues and patients.
- Demonstrates an understanding of the job description, performance expectations, and competency assessment.
- Demonstrates a commitment toward meeting and exceeding the needs of our customers and consistently adheres to customer service standards.
- Participates in departmental and/or interdepartmental quality improvement activities.
- Participates in and successfully completes Mandatory Education.
- Performs all other duties as needed or directed to meet the needs of the department.
Education and Training: Bachelors Degree in Life Science, Public Health, or Biostatistics desirable, or college with significant research experience.
Licensure, Certification, Registration: N/A
Skills, Knowledge & Abilities: Strong orginizational and communication skill, ability to function independently, 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 and statistics programs (SPSS, BMDP, or SAS) helpful but not required. In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.
Experience: Two years experience in clinical research.
40 hours, Day shift
Beth Israel Lahey Health is dedicated to improving health and wellness and making a difference in the lives of our patients, their families and all members of the communities we serve. Formed in March 2019, Beth Israel Lahey Health is a patient-centered, integrated care delivery system providing a continuum of services spanning academic, tertiary and community hospitals, dedicated orthopedic and psychiatric hospitals, primary and specialty care, community acute care, ambulatory care, behavioral services and home health. Beth Israel Lahey Health Performance Network is a unified joint contracting and population health management organization, jointly governed by participating physicians and hospitals.
Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.