Clinical Research Coordinator II

Beth Israel Lahey Health - Burlington, MA

Full-time - Mid Level

Burlington, MA

Ambulatory Health Care Services

About the position

Under minimal supervision and direction, the Clinical Research Coordinator II will be responsible for the coordination and administration of multiple research studies. This role involves implementing study protocols in accordance with regulatory and institutional requirements, working closely with principal investigators, research staff, and Research Administration to facilitate all aspects of assigned clinical trials. The coordinator will interact with study participants diagnosed with various medical conditions and diagnoses.

Responsibilities

• Possesses ongoing knowledge of FDA, OHRP and GCP regulations and 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.
• Implements assigned research studies by reviewing study and assessing protocol and institutional requirements.
• Conducts assigned research studies per protocol requirements, departmental and institutional policy.
• Recruits patients to assigned research studies and works closely with physicians to develop recruitment strategies.
• Performs Data Management duties, preparing 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.
• Maintains a professional relationship with sponsors and/or CRO's and related members.
• 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.

Requirements

• Bachelor's degree required; Master's degree preferred.
• 5+ years direct work-related experience in a research setting.
• Ability to demonstrate basic knowledge of fundamental concepts, practices and procedures.
• Ability to make decisions guided by general instructions and practices requiring some interpretation.
• Strong verbal and written communication skills.
• Ability to interact with professional personnel at all levels.
• Working knowledge of medical terminology and medical practice protocols.
• Experience with computer systems, including web-based applications.

Nice-to-haves

• In absence of a Bachelor's degree, will consider 6 years of relevant work experience.
• Ability to travel nationally to other research sites, attend investigator meetings and educational conferences as required.
• Ability to function independently, set priorities, provide clear direction and training, take initiative and work collaboratively in small teams.
• Ability to interact with study participants with various diseases compassionately and respectfully.