Clinical Research Coordinator I with Translational Research

Beth Israel Lahey Health•Burlington, VT

2d•$22 - $27

About The Position

The Clinical Research Coordinator I coordinates and administers multiple clinical research studies, working with principal investigators and research staff across assigned trials. The coordinator implements study protocols in accordance with regulatory and institutional requirements; establishes administrative systems to track study progress; and screens, recruits, follows, and collects and reports data for participants with various medical conditions. The role coordinates different phases of studies with varying complexity under moderate oversight, including study start-up, regulatory submissions, participant visits, data management, sponsor communications, monitoring, and closeout. The position also participates in departmental research initiatives and required training and quality-improvement activities. The coordinator works with physicians, senior research staff, collaborating departments, research finance, sponsors, and contract research organizations to support protocol compliance and study operations. The role requires careful handling of confidential information, professional and compassionate interactions with participants and colleagues, and the ability to travel nationally to research sites, investigator meetings, and educational conferences as required.

Requirements

Bachelor’s degree required; in lieu of a bachelor’s degree, 8 years of relevant work experience may be considered in addition to the experience requirement.
0–2+ years of experience in a research or medical setting.
No licensure, certification, or registration required.
Strong organizational, multitasking, attention-to-detail, and communication skills.
Ability to take direction, set priorities, and work somewhat independently.
Ability to work in small teams and interact with professional personnel at all organizational levels.
Ability to work compassionately and respectfully with study participants who have various diseases.
Experience with computer systems, including web-based applications.
Ability to address routine and somewhat repetitive problems by following clear directions and procedures.
Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner.
Ability to travel nationally as required.
If any listed skills are absent, ability to be thoroughly trained to meet organizational standards.
Must be vaccinated against influenza as a condition of employment.

Responsibilities

Complete new coordinator orientation and all required training.
Coordinate assigned research studies and implement protocols in accordance with Research SOPs, FDA, OHRP, GCP, and institutional requirements.
Complete study start-up checklists and plans, create source worksheets, and prepare regulatory and IRB start-up documents with assistance or guidance as needed.
Review study documents for implementation issues and establish appropriate study procedures with collaborating departments.
Ensure study team members have required training and certifications; conduct in-services and coordinate study-related activities with clinical departments.
Work with research finance on clinical trial agreements, budgets, and other applicable financial matters; attend investigator meetings as applicable.
Create and maintain eRegulatory, patient study, and case report form files, and ensure adherence to protocol requirements.
Advise physicians about required tests and procedures and their timing; ensure treating physicians receive relevant study test results as appropriate.
Administer protocol-required questionnaires and assessments, and retrieve or coordinate submission of patient samples.
Prepare and submit IRB materials, including amendments, consent revisions, annual reviews, adverse events, investigator changes, accrual-status changes, and changes in risk; comply with IRB decisions and requirements.
Use current systems to schedule tests and appointments and access patient data and results; establish tools to monitor adherence to study guidelines.
Develop recruitment strategies with physicians and senior staff; create recruitment materials and help review study listings for the Lahey website.
Screen and identify potential participants, evaluate eligibility data, contact and screen candidates, and participate in informed consent procedures.
Register or randomize participants and schedule and attend follow-up visits as applicable.
Prepare for participant visits, ensure study procedures are completed, and ensure visits and tests are billed to the appropriate insurance or research account.
Complete source worksheets and CRFs accurately and on time, support documentation with medical-chart sources, and submit CRFs to sponsors as required.
Ensure consent and related study materials are properly placed in the EMR; maintain and reorder study supplies.
Communicate with sponsors and CROs, support monitoring visits and audits, respond to requests, resolve data queries, and help ensure good clinical practice.
Complete study closeout activities and retain and archive records in accordance with institutional SOPs.
Maintain required continuing education credits, pursue additional training as needed, and participate in other research projects and initiatives as assigned.
Adhere to confidentiality, institutional policies, standards of behavior, and customer-service expectations; participate in quality-improvement activities and mandatory education; perform other duties as needed.
Travel nationally to other research sites, investigator meetings, and educational conferences as required.