Location: Burlington, MA
Job ID: 153000-1A
Date Posted: Feb 8, 2019
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: 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 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.
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 tools to track, identify and assist in patient's study progress.
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.
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.
Performs data management duties
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.
Actively screens for patient enrollment.
Educates appropriate departments of Inclusion/Exclusion Criteria and contact information.
Maintains Patient Roster with Consent Form Information.
Is a team player within the department
Is flexible with time when applicable.
Maintains CEUs if applicable.
Attends Data Management class when possible.
Seeks out information when needed.
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.
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.