Job Description
Job Description
Description : Applicants must be legally authorized to work in the United States. We are unable to provide visa sponsorship now or in the future.
Job Summary
The Clinical Research Coordinator (CRC) is primarily responsible for clinical research activities ensuring compliance with Code of Federal Regulation (CFR) Title 21, The Spine Network (TSN) Quality Program, and Good Clinical Practice (GCPs). The CRC is responsible for the day-to-day management of clinical trials, ensuring research studies run smoothly by consenting eligible participants, collecting accurate data, monitoring participant safety, and upholding compliance with regulatory guidelines, all while working closely with Sponsor and study sites to adhere to the study protocol and ethical standards throughout the research process.
Supervisory Responsibilities : None.
Duties / Responsibilities :
Study Compliance and Coordination
- Ensure all study procedures adhere to protocols, organizational policies, and regulatory guidelines
- Stay updated on and apply GCP standards and Institutional Review Board (IRB) requirements
Participant Management
Identify and screen potential study participants through medical record reviews and interviewsObtain and document informed consent, clearly explaining study procedures and potential risksCoordinate and conduct study visits, including collecting and processing samples, administering questionnairesRecord accurate data from study visits, including patient demographics, medical history, and study-specific measurementsRegulatory and Documentation
Prepare and manage study-related documents, including protocol worksheets, IRB submissions, adverse event reports, and progress updatesMaintain and review the Trial Management File (TMF) and other regulatory documentation as necessaryData and Quality Oversight
Monitor and record study data accurately, ensuring compliance with study protocols and reporting guidelinesPrepare for and participate in quality assurance audits conducted by sponsors, federal agencies, or internal review groupsCollaboration and Communication
Coordinate with investigators, healthcare professionals, and study team members to ensure seamless study executionBuild and maintain relationships with investigators, site staff, vendors, and contractorsReview and address protocol issues, proposing resolutions or updates when requiredAdditional Responsibilities
Participate in continuing education and to maintain professional competencyPerform other duties as assigned to support study successRequirements :
Required Skills / Abilities :
Familiarity with Electronic Medical Record (EMR) and radiology systems (PACS)Strong organizational and time management skillsACRP-CP or CCRC certified or willingness to obtain certificationAttention to detail and accuracy in data collection and documentationProficient in Microsoft Office applications (e.g., WORD, Excel, PowerPoint, Outlook, etc.) and electronic data capture (EDC) platformsExcellent communication, written and organizational skills (i.e., ability to prioritize a number of tasks of varying complexity), along with problem solving, and conflict resolutionAbility to motivate and collaborate with other functional teams and / or departments as necessaryAbility to work independently, take initiative, and meet TSN goals for study projects within timelines and budget requirementsAble to function in an environment where multiple competing tasks occurEducation and Experience :
Bachelor’s degree or equivalent combination of education and / or experience in science or health-related field2 years of experience in clinical research in the medical device and / or pharmaceutical industry with IDE and / or IND experience preferredClinical research experience outside the U.S. is helpful but not requiredWorking knowledge of Food and Drug Administration (FDA) regulations and GCP guidelinesWork Environment :
Prolonged periods of sitting at a desk and working on a computerRequired to use hands / fingers to type and handle materialsMust be able to lift up to 15 pounds at timesWork Authorization :
Applicants must be legally authorized to work in the United States. We are unable to provide visa sponsorship now or in the future.
EEO Statement :
The Spine Network is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.?