"Alerted.org

Job Summary

RN's with experience working in Oncology, Clinical Research or Acute Care preferred! This position offers hybrid work opportunities!

***Only Registered Nurses will be considered for this position.

The Clinical Research Coordinator (CRC) is a professional working under the direction of their Novant Health leader in conjunction with study investigators. Clinical Research Coordinators facilitate and coordinate daily clinical trial activities and play a critical role in the conduct of the study.

Our Clinical Research Coordinators are dedicated to excellence in all aspects of clinical research with a keen focus on ethics, safety, qualify and compliance. They demonstrate knowledge of complex clinical research concepts gained through education and experience and work with a high degree of independence, using discretion and independent judgement in the executions of tasks. Human relations and interpersonal skills are necessary for interacting with patients and team members. Attention to detail and accuracy is necessary as is scheduling flexibility to accommodate protocol-required activity.

Our Clinical Research Coordinators possess excellent verbal and written communication skills, including telephone diplomacy. They have a working knowledge of information systems and database management functions as well as analytical and time management skills. Clinical Research Coordinators are self-motivated and able to work independently and on a team. They are able to prioritize and possess problem-solving skills, with demonstrated competency in applying clinical knowledge to patient management. Clinical Research Coordinators must be able to meet multiple deadlines for concurrent projects and have the knowledge and assessment skills to provide age-appropriate care and protocol requirement. While most Clinical Research Coordinators operate from a central location, there may be a need to travel within the healthcare system footprint for research patient care at regional clinics, or for training. No overnight travel is typically required.

Responsibilities

+ Sets up and performs routine clinical trial related activities. Collects, enters and summarizes clinical trial data. Monitor patients, their results, detects and reports all events per protocol, applicable policies and applicable regulations.

+ Participate in or lead the day-to-day operations for all clinical research activity and study subject care

+ 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. Troubleshoots 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 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

Candidates who meet any qualification level outlined below are encouraged to apply!

Nursing Levels: Must have current or compact RN licensure in the state of North Carolina.

Clinical Research Coordinator I RN

Clinical Research Coordinator II RN

Clinical Research Coordinator III RN

Clinical Research Coordinator IV RN

Minimum 1 year* of nursing or clinical research experience required (CRA, Regulatory, clinic, floor, CRO, pharma/biotech/device company, or other related).

Minimum 5 years* of clinical research experience required.

Minimum 10 years* of clinical research experience required. Certification in Clinical Research required.**

Minimum 15 years* of clinical research experience required. Certification in Clinical Research required.**

* Education may count toward years of experience.

** Accepted certifications in Clinical Research include the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Associates (SOCRA), Regulatory Affairs Professionals Society (RAPS) or Public Responsibility in Medicine and Research (PRIM&R).

+ Additional Skills (required):

+ Requires demonstrated knowledge of complex financial research concepts gained through education and experience. Works with a high degree of independence, using direction and independent judgement in the execution of tasks.

+ Human relations and interpersonal skills necessary for interacting patients and team members.

+ 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

Job Opening ID

100499