Clinical Research Coordinator II with Transplantation

About the role

The Clinical Research Coordinator II plays a crucial role in the coordination and administration of multiple research studies. They are responsible for implementing study protocols in accordance with regulatory and institutional requirements, interacting with study participants, and working closely with principal investigators and research staff.

Responsibilities

• Possesses ongoing knowledge of FDA, OHRP and GCP regulations: Ensures adherence to regulations.
• Educates and mentors other study staff as applicable.
• 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.
• Reviews all pertinent study documents for potential implementation issues and implements plan accordingly.
• Establishes and communicates study procedures with collaborating departments to ensure compliance with all study requirements; conducts in-services.
• 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.
• 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; 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.

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: 2-5+ years direct work related experience in a research setting.
• Skills, Knowledge & Abilities: 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.

Benefits

Compliance with Lahey Hospital and Medical Center Confidentiality policy. Incorporation of Lahey Hospital and Medical Center Standards of Behavior and Guiding Principles into daily activities. Compliance with Lahey Hospital and Medical Center Policies. Compliance with behavioral expectations of the department and Lahey Hospital and Medical Center. Maintenance of courteous and effective interactions with colleagues and patients. Demonstration of an understanding of the job description, performance expectations, and competency assessment. Demonstration of a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards. Participation in departmental and/or interdepartmental quality improvement activities. Participation and successful completion of Mandatory Education. Performance of all other duties as needed or directed to meet the needs of the department.

Pay

$23.08 - $28.85