Clinical Research Coordinator I with Translational Research

Job Overview

Join the growing BILH team as a Clinical Research Coordinator. You will coordinate and administer multiple research studies, working closely with principal investigators and research staff to facilitate all aspects of clinical trials and ensure compliance with regulatory and institutional requirements.

• Complete orientation and required training courses.
• Coordinate different phases of research studies with moderate oversight and implement study protocols in accordance with FDA, OHRP, and GCP regulations.
• Prepare and submit regulatory documents, including IRB submissions such as informed consents, amendments, and adverse event reports.
• Develop and maintain study documentation, including source worksheets, case report forms (CRFs), and eRegulatory files.
• Ensure protocol adherence and communicate study requirements to investigators, physicians, and study teams.
• Recruit and screen patients, develop recruitment strategies, create study brochures, and maintain trial listings on the Lahey website.
• Obtain informed consent, register or randomize study participants, and schedule follow‑up visits.
• Administer questionnaires, perform data collection, and maintain accurate data entry into the database.
• Maintain study supplies, communicate with sponsors and CROs, and respond promptly to sponsor monitoring and audit requests.
• Assist with budget development and process clinical trial agreements with research finance.
• Coordinate study close out activities, including data queries resolution and final reporting.
• Attend investigator meetings and sponsor audits as required.
• Complete and maintain all required continuing education and training credits.
• Participate in quality improvement activities and other research projects as assigned.

• Education:
  
  Bachelor’s degree required; otherwise 8 years of relevant work experience will be considered.
• Experience:
  
  0–2+ years in a research or medical setting.
• Skills:
  
  Strong organizational, multi‑tasking, attention to detail, and communication skills; ability to work independently with moderate oversight; ability to travel nationally; familiarity with web‑based applications.
• Knowledge & Abilities:
  Ability to address routine problems, manage study protocols, collaborate with cross‑functional teams, and interact compassionately with study participants.

$19.23 – $30.77 per hour. Compensation may exceed the base rate based on seniority, experience, and applicable differential pay.

Equal Opportunity Employer / Veterans / Disabled.