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
Coordinates multiple research studies by implementing study protocols in accordance regulatory and institutional requirements. Sets up administrative systems to manage the progress of each study while screening, recruiting and educating patients and collecting and reporting study data. Maintains interdisciplinary relationship with participating physicians and clinical departments.
Essential Duties & Responsibilities including but not limited to:
- Implements assigned research studies by reviewing study and assessing institutional requirements:
- Implements all study protocols in accordance with FDA, DHHS, and GCP regulations and guidance
- Immediately develops coordinator/sponsor relationship.
- Prepares regulatory documents with some assistance/guidance from the Sr Clinical Research Associate
- Submits DR-1, study protocol, study consent form, Investigator's Brochure, IDI, IDE, CVs and Medical Licenses and all associated articles of information to the IRB in a timely manner.
- Submits all protocol amendments / consent form revisions, adverse events, notification of change in risk to the IRB in a timely manner.
- Attends Investigator's Meetings.
- Reviews study content for potential implementation issues under the guidance of the Sr Clinical Research Associate.
- Maintains Regulatory Binder.
- Prepares tracking system to monitor the study:
- Schedule/participates in sponsor monitoring visits
- Maintains patient's medical record recording to study outline.
- Maintains list of outstanding regulatory documents.
- Develops appropriate tracking mechanism with the pharmacy and lab.
- Uses computer to help track patients.
- Maintains appropriate calendars i.e.: study and sponsor appointments for physician, department and patient.
- Develops computer systems to conduct study:
- Develops computer tools to track, identify and assist in patient's study progress.
- Under the guidance of the Senior Clinical Research Conducts in-services to departments:
- Communicates with and develops interdisciplinary relationship for all departments contributing to the implementation of the study protocol;
- Develops tools to assist all departments per study procedures.
- Develops tools to help laboratory and pharmacy perform all study procedures.
- Assures that all department members are aware of study coordinator contract numbers and Inclusive/Exclusion Criteria prior to start of the study.
- Assists physicians with implementing study protocol treatment of patients.
- Completes all necessary paperwork associated with study:
- Prepares source document i.e. lab forms, pharmacy reqs., prescriptions, x-rays reqs., etc.
- Processes Regulatory Documents in a timely manner.
- Accurately completes and maintains CRFs.
- Data Management:
- Performs data management duties
- Evaluates and revises practices and procedures:
- Updates study according to amendments.
- Reviews study for problems and revises study as necessary.
- Identifies data management issues with PI / sponsor
- Revises source documents as needed and notifies all associated departments of change.
- Recruits patients to research studies:
- Actively screens for patient enrollment.
- Educates appropriate departments of Inclusion/Exclusion Criteria and contact information.
- Maintains Patient Roster with Consent Form Information.
- Participates and assist in other research projects as assigned:
- Is a team player within the department
- Is flexible with time when applicable.
- Participates in Continuing Education:
- Maintains CEUs if applicable.
- Attends Data Management class when possible.
- Seeks out information when needed.
- 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: Associates degree or equivalent work experience.
Licensure, Certification, Registration: none required.
Skills, Knowledge & Abilities: Strong organization and communication skills. The ability to function independtly and to interact with professional personnel at all levels of an orgainzation. Working knowledge of medical terminology and medical practice protocols. Working knowledge knowledge of computer databases and word processing systems.
Experience: Minimum of 2 years experience working in an inpatient or outpatient clinical setting.
Key Words: IRB, Research, Inpatient, Outpatient, Medical Terminology, Study Protocol, CRF, Burlington, MA
40 Hours / Day
Beth Israel Lahey Health is an integrated system providing patients with better care wherever they are. Care informed by world-class research and education. We are doctors and nurses, technicians and social workers, innovators and educators, and so many others. All with a shared vision for what healthcare can and should be. We are committed to attracting, developing and retaining top talent. We strive to create a diverse and inclusive workplace that reflects the communities in which we work and serve. With a team approach to care, we encourage learning and growth at all levels and offer competitive salaries and benefits.
Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.