Clinical Research Coordinator I RN
Novant Health, Wilmington, NC, United States
What We Offer
Only Registered Nurses will be considered for this position. RN's with experience working in Oncology, Clinical Research or Acute Care preferred. The position offers hybrid work opportunities.
About the Role
The Clinical Research Coordinator (CRC) works under the direction of their Novant Health leader and study investigators. CRCs facilitate and coordinate daily clinical trial activities and play a critical role in the conduct of the study.
Our CRCs are dedicated to excellence in all aspects of clinical research with a keen focus on ethics, safety, quality 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 judgment when executing tasks. Human relations and interpersonal skills are necessary for interacting with patients and team members. Attention to detail and accuracy, as well as scheduling flexibility to accommodate protocol‑required activity, are essential.
CRC’s 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. CRC’s are self‑motivated and able to work independently and on a team, prioritize, and possess problem‑solving skills. They must be able to meet multiple deadlines for concurrent projects and provide age‑appropriate care and protocol requirements. While most CRCs 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.
What You’ll Do
Set up and perform routine clinical trial related activities, collect, enter, and summarize clinical trial data.
Monitor patients, their results, detect and report 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.
Comply with all regulatory requirements related to the conduct of research (FDA, GCP, IRB, ICH). Assure regulatory submissions for all protocols, adverse events, revisions, renewals, and terminations.
Communicate protocol information (through meetings, presentations, etc.) to physicians and staff. Read and understand clinical research protocols, informed consent documents and related materials. Assist in verifying patient history and medical information to assure appropriate enrollment in clinical trials. Confer with prospective study subjects to obtain informed consent as delegated by principal investigator. Schedule and attend patient visits. Perform protocol‑driven procedures as required and per licensure. Troubleshoot enrollment and study conduct issues. Maintain clinical and professional competency standards.
Generate study‑specific source documents (paper and/or electronic) for use in clinical trial data collection. Collect blood samples, cultures, tissues and other samples for processing, shipping and or analysis. Collect and process information from patient charts, medical records, interviews and appropriate forms. Assess and report adverse events in a timely manner. Maintain protocol‑defined timelines and department guidelines. Complete study‑specific case report forms, electronic data capture systems and assure appropriate communication with study sponsors. Arrange and attend monitoring visits. Work with senior team members to prepare for and attend sponsor and/or FDA audits. Develop knowledge to understand protocol feasibility. Coordinate scheduling of pre‑site, initiation, monitoring and closeout visits. Assure drug and device accountability is up to date and available at all times.
What We’re Looking For
Nursing Levels and Experience Requirements
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.
Human relations and interpersonal skills necessary for interacting with 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 part of a team.
Ability to prioritize and problem‑solve, 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.
Why Choose Novant Health?
At Novant Health, we believe remarkable care starts with compassion for our patients, our communities, and each other. We value belonging, courage, personal growth, and teamwork, creating a space where everyone is respected, supported, and safe to show up as their full selves.
Job Opening ID: 100499
#J-18808-Ljbffr
Only Registered Nurses will be considered for this position. RN's with experience working in Oncology, Clinical Research or Acute Care preferred. The position offers hybrid work opportunities.
About the Role
The Clinical Research Coordinator (CRC) works under the direction of their Novant Health leader and study investigators. CRCs facilitate and coordinate daily clinical trial activities and play a critical role in the conduct of the study.
Our CRCs are dedicated to excellence in all aspects of clinical research with a keen focus on ethics, safety, quality 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 judgment when executing tasks. Human relations and interpersonal skills are necessary for interacting with patients and team members. Attention to detail and accuracy, as well as scheduling flexibility to accommodate protocol‑required activity, are essential.
CRC’s 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. CRC’s are self‑motivated and able to work independently and on a team, prioritize, and possess problem‑solving skills. They must be able to meet multiple deadlines for concurrent projects and provide age‑appropriate care and protocol requirements. While most CRCs 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.
What You’ll Do
Set up and perform routine clinical trial related activities, collect, enter, and summarize clinical trial data.
Monitor patients, their results, detect and report 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.
Comply with all regulatory requirements related to the conduct of research (FDA, GCP, IRB, ICH). Assure regulatory submissions for all protocols, adverse events, revisions, renewals, and terminations.
Communicate protocol information (through meetings, presentations, etc.) to physicians and staff. Read and understand clinical research protocols, informed consent documents and related materials. Assist in verifying patient history and medical information to assure appropriate enrollment in clinical trials. Confer with prospective study subjects to obtain informed consent as delegated by principal investigator. Schedule and attend patient visits. Perform protocol‑driven procedures as required and per licensure. Troubleshoot enrollment and study conduct issues. Maintain clinical and professional competency standards.
Generate study‑specific source documents (paper and/or electronic) for use in clinical trial data collection. Collect blood samples, cultures, tissues and other samples for processing, shipping and or analysis. Collect and process information from patient charts, medical records, interviews and appropriate forms. Assess and report adverse events in a timely manner. Maintain protocol‑defined timelines and department guidelines. Complete study‑specific case report forms, electronic data capture systems and assure appropriate communication with study sponsors. Arrange and attend monitoring visits. Work with senior team members to prepare for and attend sponsor and/or FDA audits. Develop knowledge to understand protocol feasibility. Coordinate scheduling of pre‑site, initiation, monitoring and closeout visits. Assure drug and device accountability is up to date and available at all times.
What We’re Looking For
Nursing Levels and Experience Requirements
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.
Human relations and interpersonal skills necessary for interacting with 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 part of a team.
Ability to prioritize and problem‑solve, 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.
Why Choose Novant Health?
At Novant Health, we believe remarkable care starts with compassion for our patients, our communities, and each other. We value belonging, courage, personal growth, and teamwork, creating a space where everyone is respected, supported, and safe to show up as their full selves.
Job Opening ID: 100499
#J-18808-Ljbffr