Clinical Research Coordinator II: Lead Study Operations

Tufts Medical Center, Inc.; Boston (MA); On-site; USD 48,000 - 60,000; Full time

Job summary

Tufts Medical Center, Inc. is seeking a research professional to assist the Principal Investigator in planning and implementing clinical research studies as assigned, supporting development of new therapies and evidence generation.

You will perform duties across recruitment, data collection, regulatory adherence, and study coordination, requiring strong organizational skills, attention to detail, and good communication. This role involves adhering to GCP guidelines and IRB requirements.

Qualifications

• Bachelor's degree OR High School Diploma or equivalent with four years of related experience.
• BLS certification may be required depending on role.
• Two years in research related activities.

Responsibilities

• Assist in recruitment of study participants.
• Screen participants for eligibility by phone, in clinic, and other settings.
• Complete follow-up with study participants as required.
• Abstract source documents and complete CRFs per best practices.
• Ensure compliance with institutional policies and regulations for human subjects.
• Assist IRB requirements: educational, document submissions, adverse event reporting, annual reviews.
• Perform basic laboratory activities as needed.
• Maintain patient confidentiality per HIPAA and secure study information; follow FDA GCP guidelines.
• Identify and resolve protocol compliance issues with investigators and sponsors.
• Coordinate tests/procedures per protocol; report results to investigators.
• Conduct tests as needed (e.g., EKGs, Walk tests).
• Organize site visits with study sponsor to review documentation.
• Maintain inventory of study supplies.
• Assess potential patients for eligibility per protocol requirements.
• Review eligibility criteria in patient records.
• Verify information with physicians; obtain informed consent signatures.
• QC check of CRFs before data entry submission.
• Coordinate resolution of data queries.
• Enter data as warranted.
• Maintain regulatory binders and study documents.
• Monitor adverse events and report to PI, sponsor, and IRB.

Skills

Organizational talents

Data collection & analysis

Attention to detail

Computer skills

Prioritization

Communication & interpersonal skills

Record-keeping

Education

Bachelor's degree OR High School Diploma with 4 years experience

Tools

None

Job description

Tufts Medical Center, Inc. is seeking a research professional to assist the Principal Investigator in planning and implementing clinical research studies as assigned, supporting development of new therapies and evidence generation.

You will perform duties across recruitment, data collection, regulatory adherence, and study coordination, requiring strong organizational skills, attention to detail, and good communication. This role involves adhering to GCP guidelines and IRB requirements.