(Hybrid) Clinical Research Coordinator - Department of Pediatrics

The Department of Pediatrics at West Virginia University is currently accepting applications for a (Hybrid) Clinical Research Coordinator. About the Opportunity West Virginia University is seeking applications for a Pediatric Clinical Research Coordinator in the Department of Pediatrics. This position is responsible for participating in the development, coordination, monitoring, and implementation of research strategies essential to the successful management of clinical trials research conducted by principal investigators. Performs a variety of independent and collaborative duties involved in clinical trials including, but not limited to, documentation, tracking, data abstraction and collection and compilation/entry of clinical research data. We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including: 37.5-hour work week 13 paid holidays ( staff holiday calendar ) 24 annual leave (vacation) days per year ( employee leave ) 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof) WVU offers a range of health insurance and other benefits 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information ? Check out retirement health insurance benefits, retirement income, and FAQ’s. Wellness programs What You%27ll Do Working with Pharm D on dosage and titration of study drug. Manages 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. Coordinates, delegates, and evaluates clinical operations of the WVU proportion of fort initiatives in conjunction with the Principal Investigators. Collaborates daily with the research nursing staff, data managers, and study coordinators. Performs protocol procedures to ensure accurate, concise compilation of research data. Attends study-sponsored clinical coordinator meetings to ensure proper management of protocols. Assures that patient visits are scheduled in accordance with protocol guidelines. Collaborates with principal investigators to identify and resolve protocol implementation problems during The design period; uses and revises/creates data forms to meet study requirements. Educates 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. Participates in organizational audits performed by monitoring and regulatory agencies. Participates in the recruitment of potential protocols for activation from industry-sponsored and other sponsoring organizations. Participates 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 a 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. The Department of Pediatrics at West Virginia University is currently accepting applications for a (Hybrid) Clinical Research Coordinator. About the Opportunity West Virginia University is seeking applications for a Pediatric Clinical Research Coordinator in the Department of Pediatrics. This position is responsible for participating in the development, coordination, monitoring, and implementation of research strategies essential to the successful management of clinical trials research conducted by principal investigators. Performs a variety of independent and collaborative duties involved in clinical trials including, but not limited to, documentation, tracking, data abstraction and collection and compilation/entry of clinical research data. We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including: 37.5-hour work week 13 paid holidays ( staff holiday calendar ) 24 annual leave (vacation) days per year ( employee leave ) 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof) WVU offers a range of health insurance and other benefits 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information ? Check out retirement health insurance benefits, retirement income, and FAQ’s. Wellness programs What You%27ll Do Working with Pharm D on dosage and titration of study drug. Manages 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. Coordinates, delegates, and evaluates clinical operations of the WVU proportion of fort initiatives in conjunction with the Principal Investigators. Collaborates daily with the research nursing staff, data managers, and study coordinators. Performs protocol procedures to ensure accurate, concise compilation of research data. Attends study-sponsored clinical coordinator meetings to ensure proper management of protocols. Assures that patient visits are scheduled in accordance with protocol guidelines. Collaborates with principal investigators to identify and resolve protocol implementation problems during The design period; uses and revises/creates data forms to meet study requirements. Educates 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. Participates in organizational audits performed by monitoring and regulatory agencies. Participates in the recruitment of potential protocols for activation from industry-sponsored and other sponsoring organizations. Participates 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 a 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. Bachelor's Degree in an allied health discipline, or related medical field. A minimum of three (3) years of experience working in a clinical setting and/or experience working in clinical trials. Any combination of related education and/or experience will be considered. All qualifications must be met by the time of employment. Knowledge, Skills and Abilities 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. 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. Assist and/or follow the direction of specialists for professional development and to determine a course of customer service. Contact investigators, coordinators, and sponsors to establish rapport, understanding, and/or inform, as well as to facilitate the use of the organization's programs, services, and/or products. 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. Bachelor's Degree in an allied health discipline, or related medical field. A minimum of three (3) years of experience working in a clinical setting and/or experience working in clinical trials. Any combination of related education and/or experience will be considered. All qualifications must be met by the time of employment. Knowledge, Skills and Abilities 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. 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. Assist and/or follow the direction of specialists for professional development and to determine a course of customer service. Contact investigators, coordinators, and sponsors to establish rapport, understanding, and/or inform, as well as to facilitate the use of the organization's programs, services, and/or products. 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. West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees. From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures. At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values — service, curiosity, respect, accountability and appreciation — unite us as Mountaineers. Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu. West Virginia University is an Equal Opportunity Employer. We invite all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or Veteran status. West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees. From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures. At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values — service, curiosity, respect, accountability and appreciation — unite us as Mountaineers. Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu. West Virginia University is an Equal Opportunity Employer. We invite all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or Veteran status.

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