Clinical Research Coordinator

Job Summary A Clinical Research Coordinator (CRC) is responsible for reviewing, processing, and managing clinical research data and documents, including regulatory and patient records. The CRC performs a variety of clinical procedures, assists with daily workload planning, and collects, records, reports, and interprets data on patients enrolled in, or seeking enrollment in, clinical studies according to protocol, SOPs, and GCPs. Responsibilities Provide clinical research support to investigators to prepare for and execute assigned research studies, including: Collect, record, and maintain research subject study data according to study protocols and SOPs, ensuring quality control for content, accuracy, and completeness. Collect and submit regulatory/ethics documentation required by the FDA and other regulatory bodies governing clinical research. Recruit and screen participants for clinical trials and maintain subject screening logs. Assist in the consent process; orient research subjects to the study purpose, procedures, and research process. Maintain source documentation based on protocol requirements. Schedule and execute study visits and perform study procedures. Handle lab testing and analysis, including specimen collection, shipment, and lab logistics. Monitor subject safety and report adverse events or reactions to the Principal Investigator and/or appropriate medical personnel. Correspond with research subjects and troubleshoot study–related questions or issues. Participate in “huddles” to confirm daily study tasks are assigned to team members and executed to expected standards. Assist with study data quality checking and query resolution. Perform a variety of complex clinical research procedures such as ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring as needed. Assist the investigator in verifying that research study objectives are met on time, within budget, and in accordance with applicable protocol requirements, regulations, and quality standards. Provide training to new site staff on study–specific topics and requirements; audit and maintain training records. Prepare for and attend study monitoring visits, audits, and regulatory inspections. Assist the research site with staffing and scheduling coverage for studies. Maintain confidentiality of data and PHI as required. Collaborate with provider offices to deliver research efficiently. Maintain stock of supplies needed for each study per protocol. Perform other duties and projects as assigned. Qualifications Bachelor's degree in a related field. 1–2 years of clinical research experience. Relevant work experience in a clinical environment or medical setting (e.g., medical assistant, assistant nurse, laboratory technician) or equivalent combination of education, training, and experience. Proficient with Microsoft Office applications. Understanding of medical terminology. Working knowledge of clinical trials. Knowledge and ability to apply GCP/ICH and all applicable FDA regulations and guidelines for human subject protection, drug, and device. In‑depth knowledge of departmental, protocol, and study‑specific operating procedures, consent forms, and study schedules. Skilled in required clinical procedures such as phlebotomy and vital signs. Strong written and verbal communication skills with good command of the English language. Ability to apply and modify professional research principles, methods, and techniques for ongoing patient care. Skill in preparing/maintaining records, writing reports, and responding to correspondence. Ability to maintain quality control standards. Ability to react calmly and effectively in all situations. Excellent organizational and problem‑solving skills. Effective time‑management skills with the ability to multitask and manage competing priorities while maintaining exceptional attention to detail. Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients. Practice a high level of integrity, honesty, and confidentiality. Benefits (Full‑Time) Competitive salary Health insurance Dental insurance Disability insurance Life insurance Paid time off Vision insurance Working Conditions This role operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites and clinics. The job routinely uses standard office equipment such as computers, phones, and scanners. Employees will be exposed to communicable diseases, toxic substances, ionising radiation, medicinal preparations, and other common clinic conditions. Tasks include standing, walking, reaching, bending, lifting, and handling patients; hand/finger dexterity and eye‑hand coordination are required. Employees are expected to work in person and are paid on a 40‑hour work week basis; occasional evening and weekend work may be required. This is an exempt position under federal and state wage and hour laws, meaning that employees are not eligible for overtime pay beyond their salary. The following statements describe the general nature and level of work performed by individuals assigned to this position; they are not exhaustive. More detailed information can be found in SOPs, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by applicable laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. Innovo will provide reasonable accommodations for qualified individuals with disabilities. Applicants must be authorized to work for any employer in the United States. Innovo Research is unable to sponsor or take over sponsorship of an employment visa at this time. #J-18808-Ljbffr