Posted : Tuesday, September 03, 2024 02:03 PM
West Virginia University Research Corporation is seeking applications for a Pediatric Clinical Nurse Coordinator
About the Opportunity
The Clinical Nurse Coordinator helps navigate, evaluate, and delegate the clinical operations of Studies and Clinical Trials.
Collaborations with Research Pharmacy, Research Lab, nursing staff, data managers and the physicians who lead the projects.
Laison with the Pharmaceutical companies sponsoring the trials.
Working closing with families and the pediatric patients that are potential patients for the protocol.
At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work.
WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs: • 13 paid holidays (staff holiday calendar) • PTO • 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC) • A range of health insurance and various other benefits • Dependent Education Scholarship • WVU Perks • And More!! What you’ll do: Work with PharmD on dosage and titration of study drug.
Manage drug treatment schedules for members of the CHRC along with the nursing staff.
Responsible for education of floor nurses regarding studies/trials with participating babies and children along with attending physicians.
Coordinate, delegate, and evaluate clinical operations of the WVU proportion of fort initiatives in conjunction with the Principal Investigators.
Collaborate daily with the research nursing staff, data managers, and study coordinators.
Perform protocol procedures to ensure accurate, concise compilation of research data.
Attend study-sponsored clinical coordinator meetings to ensure proper management of protocols.
Assure that patient visits are scheduled in accordance with protocol guidelines.
Collaborate with principal investigators to identify and resolve protocol implementation problems during the design period; use and revise/create data forms to meet study requirements.
Educate patients and/or family members, hospital, and other university research personnel regarding research study requirements to ensure that all relevant individuals adequately understand study intent and procedures.
Participate in organizational audits performed by monitoring and regulatory agencies.
Participate in the recruitment of potential protocols for activation from industry-sponsored and other sponsoring organizations.
Participate in patient recruitment efforts.
Review and discuss clinical procedures and policies within the unit with new CHRC employees to educate during the onboarding process.
Oversee nurse and clinician training in outpatient and inpatient settings on clinical trial elements.
Monitor coordinator activities during the day to ensure all protocol activities are being implemented and designed.
Inform the manager if issues or concerns arise.
Work with coordinators and other unit staff to identify tasks that could be delegated to others for additional support.
For assigned trials, shadow the unit manager/director to learn more about contract and budget negotiations.
With the new integration of the CHRC as the hub for all research involving pediatric subjects, all trials are now evaluated, feasibility performed, and disseminated out to the appropriate department(s) accordingly.
Plan and write materials required for IRB submissions.
Review submission-related documents from clinical research protocols to ensure consistency with institutional compliance guidelines.
Develop and prepare informed consent documents according to institutional guidelines.
Assist with the submission of IND safety reports and adverse event reports to the IRB.
Submit appropriate documents to close or suspend study protocols.
Assist in networking opportunities, and continuing education.
Maintain knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility and adheres to industry and government standards.
Gather anecdotal and raw data, assess situation or program information, consider options, propose resolutions, create reports, and translate data to graphical media or code.
Assist with or complete forms for IRB submissions.
Train users regarding electronic data capture applications.
Adjust, refer, and/or investigate complaints.
Testify before auditors and administrators.
Qualifications Bachelor's degree in an allied health discipline, or related medical field and/or RN degree.
Three (3) years of experience working in a clinical setting and/or experience working in clinical trials, or an equivalent combination of education and experience.
Excellent time and project management skills.
Excellent customer service skills and the ability to communicate effectively with patients and families; pharmaceutical company personnel; regulatory and monitoring agency personnel; and internal staff members and physicians.
Analytical demands - Involves coordinating a wide range of duties associated with the development, implementation, and reporting of clinical research protocols.
Ability to prioritize tasks.
Must possess and apply knowledge of many different and unrelated processes and methods related to Pediatric Clinical Trials.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively before groups.
About Research Corporation The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University.
We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.
The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.
Creating an inclusive, engaged, and dynamic environment is core to WVURC’s mission.
We welcome candidates who can contribute a range of ideas, approaches and experiences.
West Virginia University Research Corporation is proud to be an Equal Opportunity employer.
We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.
Job Posting: Feb 8, 2024 Posting Classification: Research Corporation Exemption Status: Exempt Benefits Eligible: Yes Schedule: Full-time
Collaborations with Research Pharmacy, Research Lab, nursing staff, data managers and the physicians who lead the projects.
Laison with the Pharmaceutical companies sponsoring the trials.
Working closing with families and the pediatric patients that are potential patients for the protocol.
At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work.
WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs: • 13 paid holidays (staff holiday calendar) • PTO • 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC) • A range of health insurance and various other benefits • Dependent Education Scholarship • WVU Perks • And More!! What you’ll do: Work with PharmD on dosage and titration of study drug.
Manage drug treatment schedules for members of the CHRC along with the nursing staff.
Responsible for education of floor nurses regarding studies/trials with participating babies and children along with attending physicians.
Coordinate, delegate, and evaluate clinical operations of the WVU proportion of fort initiatives in conjunction with the Principal Investigators.
Collaborate daily with the research nursing staff, data managers, and study coordinators.
Perform protocol procedures to ensure accurate, concise compilation of research data.
Attend study-sponsored clinical coordinator meetings to ensure proper management of protocols.
Assure that patient visits are scheduled in accordance with protocol guidelines.
Collaborate with principal investigators to identify and resolve protocol implementation problems during the design period; use and revise/create data forms to meet study requirements.
Educate patients and/or family members, hospital, and other university research personnel regarding research study requirements to ensure that all relevant individuals adequately understand study intent and procedures.
Participate in organizational audits performed by monitoring and regulatory agencies.
Participate in the recruitment of potential protocols for activation from industry-sponsored and other sponsoring organizations.
Participate in patient recruitment efforts.
Review and discuss clinical procedures and policies within the unit with new CHRC employees to educate during the onboarding process.
Oversee nurse and clinician training in outpatient and inpatient settings on clinical trial elements.
Monitor coordinator activities during the day to ensure all protocol activities are being implemented and designed.
Inform the manager if issues or concerns arise.
Work with coordinators and other unit staff to identify tasks that could be delegated to others for additional support.
For assigned trials, shadow the unit manager/director to learn more about contract and budget negotiations.
With the new integration of the CHRC as the hub for all research involving pediatric subjects, all trials are now evaluated, feasibility performed, and disseminated out to the appropriate department(s) accordingly.
Plan and write materials required for IRB submissions.
Review submission-related documents from clinical research protocols to ensure consistency with institutional compliance guidelines.
Develop and prepare informed consent documents according to institutional guidelines.
Assist with the submission of IND safety reports and adverse event reports to the IRB.
Submit appropriate documents to close or suspend study protocols.
Assist in networking opportunities, and continuing education.
Maintain knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility and adheres to industry and government standards.
Gather anecdotal and raw data, assess situation or program information, consider options, propose resolutions, create reports, and translate data to graphical media or code.
Assist with or complete forms for IRB submissions.
Train users regarding electronic data capture applications.
Adjust, refer, and/or investigate complaints.
Testify before auditors and administrators.
Qualifications Bachelor's degree in an allied health discipline, or related medical field and/or RN degree.
Three (3) years of experience working in a clinical setting and/or experience working in clinical trials, or an equivalent combination of education and experience.
Excellent time and project management skills.
Excellent customer service skills and the ability to communicate effectively with patients and families; pharmaceutical company personnel; regulatory and monitoring agency personnel; and internal staff members and physicians.
Analytical demands - Involves coordinating a wide range of duties associated with the development, implementation, and reporting of clinical research protocols.
Ability to prioritize tasks.
Must possess and apply knowledge of many different and unrelated processes and methods related to Pediatric Clinical Trials.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively before groups.
About Research Corporation The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University.
We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.
The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.
Creating an inclusive, engaged, and dynamic environment is core to WVURC’s mission.
We welcome candidates who can contribute a range of ideas, approaches and experiences.
West Virginia University Research Corporation is proud to be an Equal Opportunity employer.
We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.
Job Posting: Feb 8, 2024 Posting Classification: Research Corporation Exemption Status: Exempt Benefits Eligible: Yes Schedule: Full-time
• Phone : NA
• Location : Stewart Hall, 1500 University Avenue, Morgantown, WV
• Post ID: 9078079219