Clinical Research Coordinator I - Colon and Rectal Surgery

About the role

Under general supervision and direction 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.

Responsibilities

• Completes new coordinator orientation and all required trainings.
• Responsible for coordinating different phases of research studies with varying degrees of complexity with moderate oversight.
• 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.
• Prepares, completes and submits regulatory documents in a timely manner with some assistance and/or guidance from senior research staff.
• Prepares, completes and submits start up IRB documents (e.g. informed consents) in a timely manner with some assistance/guidance from senior staff.
• Reviews all pertinent study documents for potential implementation issues under the guidance of senior research staff 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/or maintains eRegulatory, patient study and CRF files.
• 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 (e.g., blood samples, urine samples, tissue, etc.).
• Sets up and maintains study supplies and reorders as necessary.
• Maintains study supplies and reorders as necessary.
• Maintains a professional relationship with sponsors and/or CRO’s and related members.
• Maintains 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.
• Participate in departmental and/or interdepartmental quality improvement activities.
• Perform all other duties as needed or directed to meet the needs of the department.

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 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.

Pay

$21.64 - $26.50