Clinical Research Coordinator

INNOVO RESEARCH INC•Pinehurst, NC

10d•$42,241 - $58,082•Onsite

About The Position

The Clinical Research Coordinator (CRC) reviews, processes, and manages clinical research data and documents, including regulatory and patient records. The role performs clinical procedures and helps plan daily workloads by collecting, recording, reporting, and interpreting data for patients enrolled in or seeking enrollment in clinical studies. Work must follow study protocols, standard operating procedures (SOPs), and Good Clinical Practice (GCP) requirements. The CRC supports investigators in preparing for and conducting research studies, coordinates study visits and procedures, maintains research and regulatory documentation, and helps protect participant safety and data quality. The position works with research subjects, provider offices, investigators, site staff, and regulatory bodies. It is an in-person role based in a professional clinical environment, with occasional visits to partner sites or clinics. Employees are expected to work 40 hours per week; occasional evening and weekend work may be required. This exempt position is not eligible for overtime pay.

Requirements

Bachelor's degree in a related field.
1–2 years of clinical research experience.
Relevant experience in a clinical or medical setting, such as medical assistant, assistant nurse, or laboratory technician, or an equivalent combination of education, training, and experience.
Proficiency with Microsoft Office applications.
Understanding of medical terminology.
Working knowledge of clinical trials.
Knowledge of and ability to apply GCP/ICH and applicable FDA regulations and guidelines concerning human-subject protection, drugs, and devices.
In-depth knowledge of departmental, protocol, and study-specific procedures, consent forms, and study schedules.
Ability to perform required clinical procedures such as phlebotomy and vital signs.
Strong written and verbal communication skills and good command of English.
Ability to apply and adapt professional research principles, methods, and techniques to provide ongoing patient care.
Skill in preparing and maintaining records, writing reports, and responding to correspondence.
Ability to maintain quality-control standards and react calmly and effectively in all situations.
Excellent organizational and problem-solving skills.
Effective time-management skills, ability to multitask and manage competing priorities, and exceptional attention to detail.
Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients.
High level of integrity and honesty, including maintaining confidentiality.
Must be authorized to work for any U.S. employer; the company cannot sponsor or take over sponsorship of an employment visa.

Responsibilities

Collect, record, and maintain research subject study data according to study protocols and SOPs, ensuring content quality, accuracy, and completeness.
Collect and submit regulatory and ethics documentation required by the FDA and other regulatory bodies.
Recruit and screen clinical trial participants and maintain screening logs.
Assist with initial and ongoing informed consent, and orient research subjects to the study, its purpose, procedures, and research process.
Maintain source documentation according to protocol requirements.
Schedule and conduct study visits and perform study procedures.
Handle laboratory testing and analysis, including preparing specimen collection tubes and coordinating shipment and laboratory logistics.
Monitor participant safety and report adverse events or reactions to the Principal Investigator and appropriate medical personnel.
Communicate with research subjects and troubleshoot study-related questions or issues.
Participate in team huddles to confirm daily study tasks are assigned and completed to expected standards.
Assist with study data quality checks and query resolution.
Perform clinical research procedures, including ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring when needed.
Assist investigators in ensuring study objectives are met on time, within budget, and in accordance with protocols, regulations, and quality standards.
Train new investigator site staff on study-specific topics and requirements.
Help maintain staff training compliance by auditing and maintaining training records.
Prepare for and attend study monitoring visits, audits, and regulatory inspections.
Assist with research-site staffing and scheduling coverage planning.
Maintain confidentiality of data and protected health information (PHI).
Collaborate with provider offices to support efficient research workflows.
Maintain supplies required to conduct each study according to protocol.
Perform other assigned duties and projects.