Clinical Research Nurse I - Cancer Center
Lebanon, New Hampshire
Employer: D-H Lebanon-MHMH
Industry: Nurses
Salary: Competitive
Job type: Full-Time
Overview
The Clinical Research Nurse I performs a variety of clinical and non-clinical tasks associated with conducting clinical research, and within the scope of licensure. Working closely with research participants and their families, they provide care, education and support throughout the trial. Under the supervision of the PI or their designee, this position collaborates with research and non-research staff, maintaining involvement throughout the clinical trial process. The role of the Clinical Research Nurse I is introductory, with assignments provided at a task level, and focused on less complex clinical research trials and processes.
Responsibilities Research Operations May arrange/schedule required appointments. Learns and supports all of aspects of the study operations (subject management/regulatory) with substantial oversight from the investigator or their designee. Primarily supports subject management, such as subject visit preparation, performs data entry in the Clinical Trial Management System (CTMS), scans informed consents into Electronic Medical Record (EMR) and supports data entry needs of the study. Regulatory Affairs Assists with compiling and maintaining essential records and documents required by Dartmouth-Hitchcock Medical Center (DHMC) and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations, including timely Institutional Review Board (IRB) submissions meeting sponsor and departmental requirements. Provides support to supervisor and IRB with regard to regulatory and sponsor-related issues. Assists with maintaining accurate and timely sponsor communications regarding status of research studies. Under the direction of the supervisor, assists DMHC investigators with regulatory processes. Maintains basic current understanding of IRB and Dartmouth-Hitchcock Health (D-HH) Institutional processes. Maintains and tracks on-site and off-site storage of required study records and assists with data entry and accurate use of a tracking system for maintaining required essential documents. Assists with local and commercial IRB, including initial submissions, modifications, renewal applications, and study closeout procedures. Assists with scheduling and coordination of site visits, participates in site visits as assigned and tracks and ensures action items noted during site visits are completed and closed. Tracks all required essential regulatory documents according to International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines including but not limited to: investigators' Curriculum Vitae (CVs), medical licenses, Collaborative Institutional Training Initiative (CITI), clinical laboratory certifications, etc. Ethics & Participant Safety Adheres to the principles for the ethical conduct of research, and safeguards for protection of human subjects especially when conducting research with vulnerable populations. Understands and prioritizes the safety of research participants. Data and Informatics Utilizes Electronic Data Capture (EDC) systems, technologies and software necessary for study operations. Completes data entry related to test results and/or measures according to protocol, and appropriate to role. Completes paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Assists with investigating incomplete, inaccurate or missing data and or documents to ensure accuracy and completeness of data; follows Standard Operating Procedures (SOPs) for data quality assurance. Appropriately utilizes standard processes, policies and systems to ensure data integrity, attribution, and security. Leadership and Professionalism Understands and demonstrates the professional guidelines and code of ethics related to the conduct of clinical research. Completes all D-H and project-specific training requirements. Site and Study Management Assists with administrative tasks associated with clinical research studies (e.g. document and supply management). Maintains lab kits and creates and maintains regulatory and subject binders. May participate in manuscript/abstract development. Communication and Team Science Communicates appropriately (written and orally) between stakeholders. Assists with communications between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems.
Performs other duties as required or assigned.
Qualifications
Required Licensure/Certifications
- Basic Life Support (BLS) certification required - Licensed Registered Nurse with NH Eligibility
Dartmouth Health is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The Clinical Research Nurse I performs a variety of clinical and non-clinical tasks associated with conducting clinical research, and within the scope of licensure. Working closely with research participants and their families, they provide care, education and support throughout the trial. Under the supervision of the PI or their designee, this position collaborates with research and non-research staff, maintaining involvement throughout the clinical trial process. The role of the Clinical Research Nurse I is introductory, with assignments provided at a task level, and focused on less complex clinical research trials and processes.
Responsibilities
Performs other duties as required or assigned.
Qualifications
- Graduate from an accredited nursing school required.
- Bachelor of Science in Nursing preferred. Must be obtained within 4 years of hire
- Previous knowledge of research preferred
- Minimum of 2 years clinical nursing experience required
- Excellent interpersonal and communication skills required
- Excellent attention to detail required
Required Licensure/Certifications
- Basic Life Support (BLS) certification required - Licensed Registered Nurse with NH Eligibility
- Area of Interest: Nursing;
- FTE/Hours per pay period: 1.00 - 1.00 - 40 hrs/week;
- Shift: Day;
- Job ID: 26067;
Dartmouth Health is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Created: 2024-08-22
Reference: 26067
Country: United States
State: New Hampshire
City: Lebanon
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