Job Details:

• 28-32 hours/week
• This job is onsite in South Carolina.
• Remote work is not available for this position.
• Must be able to draw lab samples via venipuncture.

Position Overview:

The Research Center of the Upstate(TRCU) seeks an enthusiastic Clinical Research Coordinator (CRC) to join our dynamic clinical trials team.

• The CRC will plan, coordinate, and manage all activities associated with the initiation, conduct and completion of assigned clinical trials.
• The CRC supports multiple Phase II-IV clinical trials across a variety of disciplines and investigators which may be sponsored by pharmaceutical sponsors or CRO’s.
• The CRC maintains compliance with all regulatory bodies associated with human subject research.

Duties and Responsibilities:

• Works collaboratively with Principal Investigator and clinical staff to identify eligible participants for clinical trials.
• Educates patients and their families to assure that they are informed prior to obtaining written consent.
• Required, to administer and document informed consent prior to initiation of any study-related activities.
• Prepare patient information for registration/randomization.
• Responsible for follow-up and active patient monitoring per study protocol.
• Obtain/coordinate, process and ship subject blood, cultures, tissues, and other specimens for laboratory analysis as described in the study protocol(s).
• Maintain accurate records of subject drug accountability with the receipt, inventory, and dispensation of study drugs and materials as necessary. Work with the clinical staff to administer study drugs to research subjects when applicable.
• Inspect CRFs, source documentation, and study files to ensure completeness.
• Review CRFs, source documentation, and study files with representatives from the sponsor, Clinical Research Organization (CRO), or Food and Drug Administration (FDA) at each visit. Make necessary corrections to CRFs and submit requested documentation in a timely manner.
• Comply with standard operating procedures of the sponsor, institutional review board (IRB), and CRO involved with the trial.
• Collects, maintains, and stores all relevant clinical data and case report forms, in accordance with the study sponsor and all regulatory bodies.
• Collaborate closely with the investigator and clinic staff in scheduling future appointments and explaining patient questionnaires.
• Schedule and attend all Site Initiation Visits, Monitoring Visits, Close-Out Visits etc. for all assigned studies/or when asked to attend by the Lead Clinical Coordinator.
• Responsible for preparing the research chart for internal audits.
• Responsible for evaluation and reporting serious adverse events and expedited reporting of such events if required.
• Responsible for ensuring protocol adherence by understanding, communicating, and making sure the study parameters are ordered and carried out per protocol requirements.
• Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Report any evidence of research non-compliance in a timely fashion.
• Present information and respond to questions from physicians, staff, and patients.
• Obtain all required source documentation.
• Minimal travel is required, CRC will attend management-approved educational conferences and study meetings when available.
• May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities.
• Maintain accurate and timely documentation.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
• Collaborate closely with the investigator and clinic staff in scheduling future appointments, explaining patient questionnaires.
• Assist the research team in preparation for external audits.
• Any protocol violation/deviation will be reported to the appropriate persons/departments, as needed.

Qualifications:

• Certification, Associate, or Bachelor's degree preferred, AND a minimum of two years’ experience in a clinical research setting,
• Experience coordinating different types of clinical trials.
• Phlebotomy and triage skills are a must.
• Must have intermediate knowledge of FDA and ICH/GCP guidelines.
• Experienced in IRB processes, federal research regulations and a basic understanding of funding programs and human subjects research practices.
• Clinical Research Certification (e.g., CCRC or CCRP) is highly desired.
• Proficient in the use of electronic medical records and with medical terminology.
• Proficient with Microsoft applications and databases including Outlook, Teams, Word, and Excel.
• Excellent interpersonal and customer service skills are required.
• Required Knowledge and understanding of GCP guidelines and regulatory requirements to maintain patient safety, confidentiality, and the integrity of the clinical trial process.
• Required Knowledge of the principles of research design.
• Required ability to write, edit and review progress notes. Demonstrated organization and time management/prioritization skills with the ability to work independently with minimal supervision as well as perform and follow up with multiple projects.
• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment, and have attention to detail and follow-through skills.
• Comfortable with simultaneously managing a variety of technologies across various platforms.
• The incumbent must be able to perform this job safely, without endangering the health or safety of themselves or others.