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Clinical Research Associate GastroenterologyJob ID 146358 Date posted 04/22/2018
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:
1) 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.
2) 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.
3) Develops computer systems to conduct study:
-Develops computer tools to track, identify and assist in patient's study progress.
4) 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.
5) 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.
6) Data Management:
-Performs data management duties
7) 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.
8) 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.
9) Participates and assist in other research projects as assigned:
-Is a team player within the department
-Is flexible with time when applicable.
10) Participates in Continuing Education:
-Maintains CEUs if applicable.
-Attends Data Management class when possible.
-Seeks out information when needed.
11) Incorporates Lahey Clinic Guiding Principles , Mission Statement and Goals into daily activities.
12) Complies with all Lahey Clinic Policies.
13) Complies with behavioral expectations of the department and Lahey Clinic.
14) Maintains courteous and effective interactions with colleagues and patients.
15) Demonstrates an understanding of the job description, performance expectations, and competency assessment.
16) Demonstrates a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.
17) Participates in departmental and/or interdepartmental quality improvement activities.
18) Participates in and successfully completes Mandatory Education.
19) 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 independently and to interact with professional personnel at all levels of an organization. Working knowledge of medical terminology and medical practice protocols. Working knowledge of computer databases and word processing systems.
Experience: Minimum of 2 years experience working in an inpatient or outpatient clinical setting.
About Lahey Health
At Lahey Hospital & Medical Center, as one of the world's premier health care organizations, we provide superior health care leading to the best possible outcome for every patient. We exceed our patients' high expectations for service each day. We also help advance medicine through research and the education of tomorrow's health care leaders
We care for our patients with compassion and openness, unsurpassed expertise, a drive for continuous learning improvement, and with respect, caring, teamwork, excellence and commitment to doing our personal best.
Join our team and our mission of excellence by applying today!
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