Clinical Research Coordinator II - Lowell General Hospital, Cancer Center - On-site

Hours: 40 hours weekly, Monday-Friday. Flexible schedule options: 7:00 AM–3:30 PM or 8:30 AM–5:00 PM. 4-day work week available.

Location: Lowell General Hospital - Main Campus, 295 Varnum Ave, Lowell, MA 01854 (On-Site and Hybrid). Candidates with direct experience in cancer research and local to Massachusetts are preferred.

About the Role

The Clinical Research Coordinator supports clinical trials by recruiting and screening participants, conducting informed consent, and coordinating all protocol-required visits, procedures, and follow-up. This role ensures accurate data collection, completion and quality review of Case Report Forms, and timely resolution of data queries. The CRC maintains regulatory documentation, assists with IRB submissions, and adheres to institutional, federal, and GCP requirements. Responsibilities also include arranging and performing study-related tests within training scope, monitoring adverse events, managing study supplies, and supporting sponsor site visits. Through strong organizational and communication skills, the CRC ensures protocol compliance, participant safety, and high-quality study execution.

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.

Responsibilities

• Assist in the recruitment of study participants.
• Organize strategies for recruiting and screening study participants for eligibility via telephone, clinic, or other settings.
• Complete follow-up with study participants as required.
• Perform record abstraction of source documents, conduct required study measurements, and complete study Case Report Forms following best practices.
• Comply with all institutional policies and government regulations pertaining to human subjects’ protections.
• Assist with Institutional Review Board (IRB) requirements, including submitting documents for review, adverse event reporting, and annual reviews.
• Perform basic laboratory activities as needed.
• Maintain patient confidentiality per HIPAA regulations and secure study information.
• Adhere to FDA Good Clinical Practice Guidelines.
• Identify and resolve protocol compliance issues by notifying the investigator and, if necessary, the protocol sponsor.
• Arrange necessary tests and procedures in accordance with protocol requirements and report results to the investigator.
• Perform tests as needed and appropriate to level of training, such as EKGs and walk tests.
• Organize and participate in site visits with the study sponsor to review completeness and accuracy of study documentation.
• Maintain inventory of all study supplies.
• Assess potential patients for eligibility based on protocol requirements.
• Review eligibility and ineligibility criteria in patient records and verify information with the physician.
• Interview patients to obtain eligibility information, explain the study, and obtain informed consent.
• Conduct QC checks of completed Case Report Forms (CRFs) prior to submission for data entry.
• Coordinate resolution of all data queries.
• Complete data entry as warranted.
• Maintain regulatory binders, case report forms, source documents, and other study documents.
• Monitor and report clinical adverse events to the Principal Investigator, study sponsor, and Institutional Review Board.

Requirements

• Bachelor’s degree OR High School Diploma or equivalent AND four (4) years of related experience.
• Basic Life Support (BLS) certification may be required based on specific role requirements.
• Two (2) years of experience in research-related activities.

Preferred Qualifications

• Five (5) years of experience in research-related activities.
• Previous experience in clinical trials.
• IATA Hazardous Good Shipping certification.
• CITI Human Research Protection certification.

Skills & Abilities

• High degree of organizational talent and data collection/analysis skills.
• Meticulous attention to detail.
• Excellent computer skills, including word processing.
• Ability to prioritize quickly and appropriately.
• Excellent communication and interpersonal skills.
• Systematic record-keeping.

Physical Requirements

Typical clinical and administrative office setting.

Pay

Tufts Medicine offers competitive pay reflecting the minimum qualifications for the role. Individual offers consider relevant experience, certifications, education, skills, and internal equity. The base pay range for this position is $47,924.24 – $59,894.75.

Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package supporting health, financial security, and career growth.