Beth Israel Lahey Health · 5 months ago
Clinical Research Coordinator II, Clinical Research Support Center
Lahey Hospital and Medical Center
Full-time
Onsite
Entry, Mid Level
2+ years expBeth Israel Lahey Health is a growing healthcare organization dedicated to making a difference in people's lives. The Clinical Research Coordinator II will be responsible for coordinating and administering multiple research studies, ensuring compliance with regulatory requirements, and working closely with principal investigators and research staff.
Elder CareHealth CareHospitalPrimary and Urgent CareProfessional ServicesTraining
Responsibilities
Possesses ongoing knowledge of FDA, OHRP and GCP regulations:
Ensures adherence to regulations
Educates and mentors other study staff as applicable
Responsible for coordinating different phases of research studies with varying degrees of complexity with minimal oversight:
Completes and submits trial feasibility forms; coordinates and obtains non-disclosure agreements
Arranges and conducts pre-study qualification and site visits
Acts as the main liaison of communication between sponsors and investigators in all aspects of study start up
Implements assigned research studies by reviewing study and assessing protocol and institutional requirements:
Implements all study protocols in accordance with research SOPs, FDA, OHRP, and GCP regulations
Immediately develops coordinator/sponsor relationship
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
Conducts assigned research studies per protocol requirements, departmental and institutional policy:
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
Recruits patients to assigned research studies:
Works closely with physicians to develop recruitment strategies
Creates research brochures and other related recruitment materials; creates and/or reviews study trial listing for the Lahey website
Actively screens for and identifies eligible patients through various means (e.g. physician schedules, clinical or research databases, website response)
Evaluates patient data to determine if patient meets study eligibility, including reviewing screening eligibility tests, under minimal supervision
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
Performs Data Management duties:
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
Maintains study supplies and reorders as necessary
Maintains a professional relationship with sponsors and/or CRO’s and related members:
Maintains regular and appropriate communication
Works with sponsor monitors during monitoring visits; promptly responds to sponsor requests for additional material, clarifying material or missing material
Works cooperatively with sponsor to ensure that good clinical practice are being followed
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
Works in collaboration with research finance on all study related finances including clinical trial agreements, budget preparation, patient related study visits, invoicing and helping to resolve study subject billing issues
Seeks additional training or guidance when necessitated; utilizes available research tools and resources
Completes and maintains all required trainings:
Participates in and actively seeks continuing education opportunities
Maintains required continuing education credits per institutional and departmental SOPs
Participates and assists in other research projects and initiatives as assigned:
Is a team player within the department
Is flexible with time when applicable
Qualification
Required
Bachelor's degree required
In absence of a Bachelor's degree, will consider 8 years of relevant work experience in addition to the experience noted below
2-5+ years direct work related experience in a research setting
Ability to demonstrate basic knowledge of fundamental concepts, practices and procedures with the ability to use them in varied situations
Ability to make decisions that are guided by general instructions and practices requiring some interpretation
Seeks assistance when confronted with difficult and/or unpredictable situations
Ability to travel nationally to other research sites, attend investigator meetings and educational conferences as required
Strong verbal and written communication, multi-tasking, attention to detail and organizational skills
Ability to interact with professional personnel at all levels
Ability to communicate clearly and effectively
Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner
Ability to function independently, set priorities, provide clear direction and training, take initiative and work collaboratively in small teams
Ability to interact with study participant with various diseases compassionately and respectfully
Working knowledge of medical terminology and medical practice protocols
Experience with computer systems, including web based applications
In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards
Company
Beth Israel Lahey Health
Beth Israel Lahey Health Center offers patient care, urgent care, assisted living, and research and education services.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Robert Fields
Chief Clinical Officer and Executive Vice President
Recent News
Boston Globe
2025-11-24
Morningstar.com
2025-11-07
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