Clinical Research Coordinator I With Transplantation

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)

Summary

The Clinical Research Coordinator I will be responsible for the coordination and administration of multiple research studies. Works closely with principal investigators and research staff facilitating all aspects of assigned clinical trials. Implements study protocols in accordance to regulatory and institutional requirements. Sets up administrative systems to manage the progress of each study while screening, recruiting and following study participants and collecting and reporting study data. Interacts with study participants diagnosed with various medical conditions and diagnoses.

:

Essential Duties & Responsibilities including but not limited to:

• Recruits patients to assigned research studies:
• Retains records and archives documents according to institutional SOPs.
• Is a team player within the department.
• Reviews all pertinent study documents for potential implementation issues under the guidance of senior research staff and implements plan accordingly.
• Establishes monitoring tools to ensure the adherence to study guidelines (e.g. patient enrollment tracking).
• Maintain regular and appropriate communication.
• Creates and/or maintains eRegulatory, patient study and CRF files.
• Administers questionnaires and assessments as mandated by the protocol and delegated by the PI.
• Immediately develops coordinator/sponsor relationship.
• Maintains a professional relationship with sponsors and/or CRO’s and related members:
• Advises physicians on required tests, timing of tests and procedures; Ensures that all appropriate treating physicians receive the results of study tests, as appropriate.
• Contacts and screens potential subjects for the study with guidance from senior staff.
• 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.
• 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.
• Responsible for coordinating different phases of research studies with varying degrees of complexity with moderate oversight.
• Provides source documentation from the medical chart for all information that is recorded.
• Schedules sponsor audits, as requested, and is available during audit to review study records and procedures with sponsor personnel, as necessary.
• Performs Data Management duties.
• Completes new coordinator orientation and all required trainings.
• 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).
• 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 moderate assistance/guidance from senior staff; Complies with IRB decisions, conditions and requirements.
• 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.
• Prepares, completes and submits start up IRB documents (e.g. informed consents) in a timely manner with some assistance/guidance from senior staff.
• Implements assigned research studies by reviewing study and assessing protocol and institutional requirements:
• Registers or randomizes study participants to assigned research study and treatment/arm; schedules and attends follow-up visits, as applicable.
• Attends Investigator Meetings, as applicable.
• Is flexible with time when applicable.
• Ensures appropriate training and certification for all members of the study team involved in the research protocol.
• Resolves data queries timely and appropriately.
• Completes study close out activities at the end of the study.
• Participates in the informed consent process; obtains subjects signatures and processes appropriately per research policies.
• Responsible for ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
• Participates and assists in other research projects and initiatives as assigned:
• Prepares, completes and submits regulatory documents in a timely manner with some assistance and/or guidance from senior research staff.
• Actively screens for and identifies eligible patients through various means (e.g. physician schedules, clinical or research databases, website response).
• Maintains required continuing education credits per institutional and departmental SOPs.
• Utilizes current systems to schedule tests and appointments and to access patient data and test results.
• Implements all study protocols in accordance with Research SOPs, FDA, OHRP, and GCP regulations.
• Maintains study supplies and reorders as necessary.
• Under moderate supervision, evaluates patient data including reviewing screening eligibility tests to determine if patient meets study eligibility.
• Completes start-up checklists and implements study start-up plan, including source worksheet creation.
• Seeks additional training or guidance when necessitated; utilizes available research tools and resources.
• Directly retrieves and/or coordinates the retrieval and submission of patient samples (e.g., blood samples, urine samples, tissue, etc.).
• Submits CRFs to the sponsor as dictated by the study; Maintains sufficient files in the department to document submission and maintain source documentation.
• Conducts assigned research studies per protocol requirements, departmental and institutional policy:
• Works closely with physicians and senior staff to develop recruitment strategies.
• Ensures proper placement of consent and related study materials in EMR system.
• Participates in and actively seeks continuing education opportunities.
• Creates research brochures and other related recruitment materials; creates and/or reviews study trial listing for the Lahey website in collaboration with senior staff.
• Completes and maintains all required trainings:
• Works collaboratively with research finance to process clinical trial agreements, study budget development and other finance issues, as applicable.

Organizational Requirements:

• Maintain courteous and effective interactions with colleagues and patients.
• Participate in and successfully completes Mandatory Education.
• Perform all other duties as needed or directed to meet the needs of the department.
• Maintain strict adherence to the Lahey Hospital and Medical Center Confidentiality policy.
• Participate in departmental and/or interdepartmental quality improvement activities.
• Incorporate Lahey Hospital and Medical Center Standards of Behavior and Guiding Principles into daily activities.
• Demonstrate a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.
• Demonstrate an understanding of the job description, performance expectations, and competency assessment.
• Comply with all Lahey Hospital and Medical Center Policies.
• Comply with behavioral expectations of the department and Lahey Hospital and Medical Center.

Minimum Qualifications:

• Ability to address problems that are routine, somewhat repetitive and generally solved by following clear directions and procedures; Ability to travel nationally to other research sites, attend investigator meetings and educational conferences as required; Strong organizational, multi-tasking, attention to detail and communication skills; Ability to take direction, set priorities and work somewhat independently; Ability to demonstrate a positive attitude and respond to request in a timely and respectful manner; Ability to work in small teams, interact with professional personnel at all levels of an organization, and work with study participants of various diseases compassionately and respectfully; 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.
• Skills, Knowledge & Abilities:
• Education: 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.
• Experience: 0-2+ years experience in a research or medical setting
• Licensure, Certification & Registration: None required

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. Learn more about this requirement.

More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.

Equal Opportunity Employer/Veterans/Disabled