Overview:
The clinical research coordinator (CRC) is a clinical research professional working under the direction of their Novant Health leader and the principal investigator. Clinical research coordinators facilitate and coordinate the daily clinical trial activities and play a critical role in the conduct of the study. Dedicated to excellence in all aspects of clinical research with a keen focus on ethics, safety, qualify and compliance.
**This is a hybrid position. Candidates must be located in the Wilmington, NC area.
Only considering candidates with experience in Clinical Research.
Responsibilities:
* Sets up and performs routine clinical trial related activities. Collects, enters and summarizes clinical trial data. Monitors patients, their results, detects and reports all events per protocol, applicable policies and applicable regulations.
* Complies with all regulatory requirements related to the conduct of research (FDA, GCP, IRB, ICH). Assures regulatory submissions for all protocols, adverse events, revisions, renewals, and terminations.
* Communicates protocol information (through meetings, presentations, etc.) to physicians and staff. Read and understand clinical research protocols, informed consent documents and related materials. Assists in verifying patient history and medical information to assure appropriate enrollment in clinical trials. Confers with prospective study subjects to obtain informed consent as delegated by principal investigator. Schedules and attends patient visits. Perform protocol driven procedures as required and per licensure. Troubleshoot enrollment and study conduct issues. Maintains clinical and professional competency standards.
* Generates study specific source documents (paper and/or electronic) for use in clinical trial data collection. Collects blood samples, cultures, tissues and other samples for processing, shipping and or analysis. Collects and process information from patient charts, medical records, interviews and appropriate forms. Assesses and reports adverse events in a timely manner. Maintains protocol defined timelines and department guidelines. Completes study specific case report forms, electronic data capture systems and assures appropriate communication with study sponsors. Arranges and attends monitoring visits. Works with Sr. team members to prepare for and attend sponsor and/or FDA audits. Develop knowledge to understand protocol Screens incoming research proposals for feasibility. With leader or senior team member guidance, Coordinates scheduling of pre-site, initiation, monitoring and closeout visits. Assures drug and device accountability is up to date and available at all times.
Qualifications:
* Education: High School Diploma or GED, required. 4 Year / Bachelors Degree, preferred.
* Experience: Two years experience in clinical research and/or relevant clinical field, preferred.
* Licensure/Certification: Two years in a healthcare setting or clinical research (CRA, Regulatory, clinic, CRO, pharma/biotech/device company, or other related experience), preferred.
* Additional Skills (required): Requires demonstrated knowledge of complex clinical research concepts gained through education and experience. Works with a high degree of independence, using discretion and independent judgement in the executions of tasks. Human relations and interpersonal skills necessary for interacting with patients and staff. Attention to detail and accuracy necessary. Ability and willingness to work irregular hours as necessitated by research protocols. Excellent verbal and written communication skills. Excellent telephone diplomacy. Working knowledge of Information Systems and database management. Excellent analytical and time management skills. Self-motivated and able to work independently as well as a team. Ability to prioritize and problem solving skills, with demonstrated competency in applying clinical knowledge to patient management. Able to meet multiple deadlines for concurrent projects. Knowledge and assessment skills to provide age appropriate care and protocol requirements.
* Additional Skills (preferred): Good Clinical Practice (GCP), Human Subjects Training, and International Air Transportation Association (IATA) certification for shipping hazardous and biological substances. Certification in research.
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