Clinical Research Coordinator

Company Description

Data Point Clinical LLC is a trusted clinical research partner, dedicated to delivering high-quality data through precise study execution and strong patient engagement. Collaborating with sponsors and CROs, we focus on enhancing operational efficiency, improving recruitment outcomes, and ensuring seamless trial execution. Our experienced, senior-led team emphasizes accuracy, speed, and exceptional patient experience. We are committed to accelerating the development of new therapies while adhering to the highest standards of compliance and care.

Position Summary

The Clinical Research Coordinator (CRC) plays a central role in the planning, implementation, and management of clinical research studies. This position is responsible for ensuring the ethical conduct of research, maintaining regulatory compliance, and providing high-quality patient care throughout the research process. The CRC serves as a key liaison between study participants, investigators, sponsors, and regulatory agencies.

Key Responsibilities

Study Coordination & Operations

• Coordinate and manage day-to-day clinical trial activities in accordance with study protocols, GCP guidelines, and applicable regulations (FDA, ICH, IRB)
• Screen and enroll eligible study participants; obtain and document informed consent
• Schedule and conduct study visits, procedures, and assessments per protocol requirements
• Collect, process, and ship biological specimens including blood draws (phlebotomy required)
• Perform and document study-related procedures such as vital signs, ECGs, and questionnaire administration
• Maintain accurate and complete source documentation and case report forms (CRFs/eCRFs)
• Additional responsibilities may apply

Regulatory & Compliance (in collaboration with Regulatory Staff)

• Partner with the regulatory team on IRB submissions, amendments, renewals, and adverse event reporting
• Assist with maintaining and organizing the Investigator Site File (ISF) and regulatory binders
• Identify and communicate protocol deviations to the PI and regulatory staff in a timely manner
• Support monitoring visits, audits, and sponsor/CRO site visits alongside the regulatory team
• Maintain working knowledge of applicable GCP guidelines, FDA regulations, and institutional policies
• Additional responsibilities may apply

Patient Care & Safety

• Perform phlebotomy and specimen collection following established safety and quality procedures
• Monitor participants for adverse events (AEs) or serious adverse events (SAEs) and report findings to the PI and sponsor per protocol
• Provide participant education and ongoing study-related support throughout the trial
• Coordinate with clinical staff to ensure continuity of participant care
• Additional responsibilities may apply

Data Management & Reporting

• Enter study data accurately and in a timely manner into electronic data capture (EDC) systems
• Resolve data queries from sponsors, monitors, and data managers
• Assist with preparation of study reports, presentations, and publications as needed
• Track enrollment metrics, visit completion, and study milestones
• Additional responsibilities may apply

Communication & Collaboration

• Act as the primary point of contact for study sponsors, CROs, and external collaborators
• Communicate study updates to the research team, investigators, and institutional departments
• Participate in research team meetings, investigator meetings, and training sessions
• Mentor and provide guidance to junior research staff as appropriate

Qualifications

Education

• Associate degree or higher in a health-related field required; Bachelor's degree preferred
• Coursework or training in clinical research, life sciences, nursing, or a related discipline

Experience

• Minimum 2 years of clinical research coordination or directly related clinical experience required
• Demonstrated experience with informed consent processes and human subjects research
• Experience with EDC systems and clinical trial management software preferred
• Familiarity with FDA regulations, ICH-GCP guidelines, and IRB submission processes

Required Licensure (One of the following must be active and in good standing)

• Medical Assistant-Phlebotomist (MA-P) License
• Phlebotomy Technician License/Certification
• Registered Nurse (RN) License

Skills & Competencies

• Proficient phlebotomy skills with demonstrated ability to perform venipuncture and capillary collection
• Strong organizational skills with meticulous attention to detail and accuracy
• Excellent written and verbal communication skills
• Ability to work independently and manage multiple protocols simultaneously
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and database software
• Demonstrated ability to maintain strict confidentiality and handle sensitive information with discretion

Working Conditions

• Clinical and office environment; standard research facility settings
• May require occasional evening or weekend hours to accommodate study visit schedules
• Exposure to biological specimens; adherence to universal precautions and safety protocols required
• Ability to stand, sit, and perform physical tasks associated with clinical procedures for extended periods

Preferred Qualifications

• Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification (CCRC, CRC, or equivalent)
• Bilingual language skills are a plus
• Prior experience with sponsor-initiated or investigator-initiated trials

Benefits

• Paid Time Off (PTO)
• Qualified Small Employer Health Reimbursement Arrangement (QSEHRA)

This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of skills, efforts, duties, or responsibilities associated with it. Job duties may be modified at any time.