Clinical Research Coordinator I with Translational Research

3M HEALTHCARE; Burlington (MA); On-site; USD 26,491 - 42,388; Full time

Job summary

Lahey Clinic is seeking a Clinical Research Coordinator to coordinate and administer multiple studies, working with principal investigators and staff to ensure regulatory compliance and quality data collection.

Responsibilities include preparing regulatory submissions, maintaining study documents, recruiting participants, and coordinating with sponsors and CROs. A Bachelor’s degree (or 0–2 years) and strong organizational skills are required; travel nationwide may be required.

Qualifications

• Bachelor’s degree required or 8 years of relevant work experience.
• 0–2+ years in a research or medical setting.
• Strong organizational and communication skills; ability to work independently with moderate oversight.

Responsibilities

• 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.

Skills

Organizational skills

Multitasking

Attention to detail

Communication skills

Travel nationally

Web-based applications

Education

Bachelor’s degree or 8 years relevant work experience

Job description

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.

Responsibilities

• 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.

Minimum Qualifications

• 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.

Pay Range

$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.