Clinical Research Coordinator I with Translational Research

About the Role

Clinical Research Coordinator I with Translational Research

Key Responsibilities

• Coordinate and administer multiple research studies.
• Work closely with principal investigators and research staff facilitating all aspects of assigned clinical trials.
• Implement study protocols in accordance with regulatory and institutional requirements.
• Set up administrative systems to manage study progress, screen, recruit and follow study participants, and collect/report study data.
• Interact with study participants diagnosed with various medical conditions and diagnoses.
• Complete new coordinator orientation and all required trainings.
• Coordinate research studies with varying degrees of complexity with moderate oversight.
• Implement assigned research studies by reviewing study protocols and assessing protocol and institutional requirements.
• Implement all study protocols in accordance with Research SOPs, FDA, OHRP, and GCP regulations.
• Develop coordinator/sponsor relationships.
• Complete start-up checklists and implement study start-up plans, including source worksheet creation.
• Prepare, complete, and submit regulatory documents in a timely manner with some assistance and/or guidance from senior research staff.
• Prepare, complete, and submit start-up IRB documents (e.g., informed consents) in a timely manner with some assistance/guidance from senior staff.
• Review all pertinent study documents for potential implementation issues under the guidance of senior research staff and implement plans accordingly.
• Ensure appropriate training and certification for all members of the study team involved in the research protocol.
• Establish and communicate study procedures with collaborating departments to ensure compliance with all study requirements; conduct in-services.
• Work collaboratively with research finance to process clinical trial agreements, study budget development, and other finance issues, as applicable.
• Attend Investigator Meetings, as applicable.
• Conduct assigned research studies per protocol requirements, departmental and institutional policy.
• Create and/or maintain eRegulatory, patient study, and CRF files.
• Ensure protocol adherence by understanding, communicating, and ensuring study parameters are ordered and carried out per protocol requirements.
• Advise physicians on required tests, timing of tests, and procedures; ensure appropriate treating physicians receive study test results, as appropriate.
• Administer questionnaires and assessments as mandated by the protocol and delegated by the PI.
• Directly retrieve and/or coordinate the retrieval and submission of patient samples (e.g., blood samples, urine samples, tissue, etc.).
• Submit all IRB submission documents such as protocol amendments, consent form revisions, annual reviews, adverse events, investigator changes, accrual status changes, and changes in risk to the IRB in a timely manner with moderate assistance/guidance from senior staff; comply with IRB decisions, conditions, and requirements.
• Utilize current systems to schedule tests and appointments and to access patient data and test results.
• Establish monitoring tools to ensure adherence to study guidelines (e.g., patient enrollment tracking).
• Recruit patients to assigned research studies.
• Work closely with physicians and senior staff to develop recruitment strategies.
• Create research brochures and other related recruitment materials; create and/or review study trial listings for the Lahey website in collaboration with senior staff.
• Actively screen for and identify eligible patients through various means (e.g., physician schedules, clinical or research databases, website response).
• Under moderate supervision, evaluate patient data, including reviewing screening eligibility tests, to determine if a patient meets study eligibility.
• Contact and screen potential subjects for the study with guidance from senior staff.
• Participate in the informed consent process; obtain subject signatures and process appropriately per research policies.
• Register or randomize study participants to assigned research study and treatment/arm; schedule and attend follow-up visits, as applicable.
• Perform Data Management duties.
• Prepare for each study participant visit to ensure all appropriate study procedures are done per protocol; ensure patient visit/test is billed correctly to either insurance or the research account per schema.
• Complete source worksheets and CRFs as dictated by the assigned research study; ensure CRFs and source documentation are complete and correct.
• Provide source documentation from the medical chart for all information recorded.
• Submit CRFs to the sponsor as dictated by the study; maintain sufficient files in the department to document submission and maintain source documentation.
• Ensure proper placement of consent and related study materials in the EMR system.
• Maintain study supplies and reorder as necessary.
• Maintain a professional relationship with sponsors and/or CROs and related members.
• Maintain regular and appropriate communication.
• Work with sponsor monitors during monitoring visits; promptly respond to sponsor requests for additional, clarifying, or missing material.
• Work cooperatively with sponsors to ensure good clinical practice is followed.
• Resolve data queries timely and appropriately.
• Schedule sponsor audits, as requested, and be available during audits to review study records and procedures with sponsor personnel, as necessary.
• Complete study close-out activities at the end of the study.
• Retain records and archive documents according to institutional SOPs.
• Complete and maintain all required trainings.
• Participate in and actively seek continuing education opportunities.
• Maintain required continuing education credits per institutional and departmental SOPs.
• Seek additional training or guidance when necessitated; utilize available research tools and resources.
• Participate and assist in other research projects and initiatives as assigned.
• Be a team player within the department.
• Be flexible with time when applicable.

Organizational Requirements

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

Requirements & Tech Stack

• Bachelor’s degree required. In absence of a Bachelor’s degree, 8 years of relevant work experience will be considered in addition to the experience noted below.
• None required for Licensure, Certification & Registration.
• 0-2+ years experience in a research or medical setting.
• Skills, Knowledge & Abilities:
• 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 requests 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, demonstrate the ability to be thoroughly trained to meet organizational standards.

Qualifications

• 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.
• Licensure, Certification & Registration: None required.
• Experience: 0-2+ years experience in a research or medical setting.
• Skills, Knowledge & Abilities:
• 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 requests 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.