- Creates and maintains eRegulatory, patient study, and CRF files.
- Thoroughly learns assigned protocols and serves as resource for all study team members.
- Responsible for ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
- Advises physicians on required tests, timing of tests and procedures.
- Ensures that all appropriate treating physicians receive the results of study tests, as appropriate.
- Administers questionnaires and assessments as mandated by the protocol and delegated by the PI.
- Directly retrieves and/or coordinates the retrieval and submission of patient samples or tests (e.g., blood samples, urine samples, tissue, ECG, etc.).
- Submits all IRB submission documents such as protocol amendments and consent form revisions, annual reviews, adverse events, investigator changes, accrual status change and change in risk to the IRB in a timely manner with minimal assistance/guidance from senior staff; Complies with IRB decisions, conditions and requirements.
- Utilizes current systems to schedule tests and appointments and to access patient data and test results.
- Establishes monitoring tools to ensure the adherence to study guidelines (e.g. patient enrollment tracking).
- May assist with the coordination of preparing summary reports, study results, poster presentations and manuscripts for publication.
- Works closely with physicians to develop recruitment strategies.
- Creates research brochures and other related recruitment materials.
- Actively screens for and identifies eligible patients through various means (e.g. physician schedules, clinical or research databases, website response).
- Contacts and screens potential subjects for the study.
- Participates in the informed consent process; obtains subjects signatures and processes appropriately per research policies.
- Registers or randomizes study participants to assigned research study and treatment/arm; schedules and attends study follow-up visits, as applicable.
- Prepares for each study participant visit to ensure all appropriate study procedures are done per protocol; ensures patient visit/test is billed correctly to either insurance or the research account per schema.
- Completes source worksheets and case report forms (CRFs) as dictated by the assigned research study (i.e. required forms in the required format in the required time interval); Ensures CRF's and source are complete and done correctly.
- 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.
- Ensures proper placement of consent and related study materials in EMR system.
- Documents data in accordance with ALCOA-C principles
- Maintains study supplies and reorders as necessary.
- Works with sponsor monitors during monitoring visits; promptly responds to sponsor requests for additional material, clarifying material or missing material.
- Resolves data queries timely and appropriately.
- Schedules sponsor audits, as requested, and is available during audit to review CRFs and procedures with sponsor personnel, as necessary.
- Completes study close out activities at the end of the study.
- Retains records and archives documents according to institutional SOPs.
- Implements all study protocols in accordance with research SOPs, FDA, OHRP, and GCP regulations.
- Completes start- up checklists and organizes study start-up plan, including source worksheet creation.
- Prepares, completes and submits regulatory documents in a timely manner.
- Prepares, completes and submits start up IRB documents in a timely manner.
- Reviews all pertinent study documents for potential implementation issues and implements plan accordingly.
- Ensures appropriate training and certification for all members of the study team involved in the research protocol.
- Establishes and communicates study procedures with collaborating departments to ensure compliance with all study requirements; conducts in-services (e.g. arranges special blood draws with phlebotomy, special blood processing with specimen processing, ordering and receiving of drug with the pharmacy and infusion team, and copying and submission of MRI with Radiology).
- Works collaboratively with research finance to process clinical trial agreements, study budget development and other finance issues, as applicable.
- Attends Investigator Meetings as applicable.
- Bachelor's degree with science/research related study required
- In absence of a Bachelor's degree, will consider 8 years of relevant work experience in addition to the experience noted below.
- None required
- 2-5+ years direct work related experience in a research setting.
- Familiarity with electronic medical record platform (Epic) & HIPAA compliant data capture platform (REDCap) preferred.
- Experience with phlebotomy preferred.
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Registered Nurse - Burlington, MA, United States - Beth Israel Lahey Health
Description
Job Type:
Regular
Time Type:
Full time
Work Shift:
Day (United States of America)
FLSA Status:
Non-Exempt
When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.
Job Type:
Regular
Scheduled Hours:
40
Work Shift:
Day (United States of America)
The Hypertrophic Cardiomyopathy (HCM) team at Lahey Hospital and Medical Center is currently seeking an experienced clinical research coordinator to join our research team.
HCM is the most common inherited heart condition with a prevalence of 1:500 globally and remains the most common cause of sudden death in young patients and a major cause of heart failure in patients of all ages.
The HCM center at Lahey Hospital & Medical Center is one of the most experienced and comprehensive in the world.
Recognized as an international Center of Excellence, the Lahey HCM Center is at the leading edge of research on this disease.
The successful candidate must be able to interact positively with all members of a multidisciplinary HCM care team and work collaboratively in an environment where quality, collegiality and caring come first.
Job Description:
Essential Duties & Responsibilities including but not limited to:
Minimum Qualifications:
Education:
Licensure, Certification & Registration:
Experience:
FLSA Status:
Non-Exempt
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities.
Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment.
