Clinical Research Coordinator II - Lowell General Hospital, Cancer Center - Hybrid

Tufts Medicine•Lowell, MA

14d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience.
Basic Life Support (BLS) certification may be based on specific role requirements.
Two (2) years in research related activities.
High degree of organizational talents, data collection and 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.

Nice To Haves

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

Responsibilities

Assisting in the recruitment of study participants.
Organizing strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings.
Completing follow up with study participants in prescribed settings.
Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.
Complying with all institutional policies and government regulations pertaining to human subjects’ protections.
Assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.
Performing basic laboratory activities as needed.
Maintaining patient confidentiality per HIPAA regulations and keeping study information in a safe and secure location.
Adhering to FDA Good Clinical Practice Guidelines.
Identifying and resolving problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
Arranging necessary tests and procedures in accordance with protocol requirements and reporting results to the investigator.
Performing necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.
Organizing and participating in site visits with the study sponsor to review completeness and accuracy of study documentation.
Maintaining inventory of all study supplies.
Assessing potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.
Reviewing all eligibility and ineligibility criteria in the patient’s record.
Verifying information with the physician.
Interviewing patients to obtain information for eligibility assessment, explaining the study, and obtaining signature for the informed consent form.
Conducting a QC check of completed CRFs prior to submission for data entry.
Coordinating resolution of all data queries.
Completing data entry as warranted.
Maintaining regulatory binders, case report forms, source documents, and other study documents.
Monitoring the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.