Clinical Research Coordinator - Lead Study Operations

Tufts Medical Center, Inc.; United States; On-site; USD 48,000 - 60,000; Full time

Job summary

Tufts Medical Center, Inc. seeks a research assistant to support planning and implementation of clinical studies under the Principal Investigator. The role includes participant recruitment, data collection, and regulatory duties within a clinical research environment.

The ideal candidate will have a bachelor’s degree or equivalent with multiple years in research activities, and may require BLS certification. Strong organizational and communication skills are essential for success.

Qualifications

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

Responsibilities

• Assist in recruitment of study participants.
• Screen and enroll participants for eligibility by phone, clinic, or other settings.
• Complete follow-up with participants per protocol.
• Abstract source documents and complete case report forms per best practices.
• Adhere to institutional policies and government regulations on human subjects protection.
• Assist with IRB requirements and annual reviews as needed.
• Perform basic laboratory activities as required.
• Maintain patient confidentiality per HIPAA and secure study data per FDA GCP.
• Identify protocol compliance issues and communicate with investigator and sponsor as needed.
• Arrange tests and procedures per protocol and report results to the investigator.
• Conduct required tests (e.g., EKGs, Walk tests) as training allows.
• Coordinate site visits with study sponsor to review documentation.
• Maintain inventory of study supplies.
• Assess potential patients for protocol eligibility.
• Review eligibility criteria in patient records.
• Verify information with physician and obtain informed consent signatures.
• QC check CRFs before data entry submission.
• Coordinate resolution of data queries and data entry.
• Maintain regulatory binders, CRFs, and source documents.
• Monitor adverse events and report to PI, sponsor, and IRB.
• Support clinical trial activities as required.

Skills

Organizational skills

Data analysis

Attention to detail

Word processing

Prioritization

Communication skills

Education

Bachelor’s degree

HS Diploma + 4 years related experience

Tools

Microsoft Word

Job description

Tufts Medical Center, Inc. seeks a research assistant to support planning and implementation of clinical studies under the Principal Investigator. The role includes participant recruitment, data collection, and regulatory duties within a clinical research environment.

The ideal candidate will have a bachelor’s degree or equivalent with multiple years in research activities, and may require BLS certification. Strong organizational and communication skills are essential for success.