A Commonwealth of Virginia Website
Virginia Mountain View

Clinical Research Coordinator 3 or 4, Department of Pediatrics UVA Intensive Care (NICU, PICU)

Charlottesville

Clinical Research Coordinator 3 or 4, Department of Pediatrics UVA Intensive Care (NICU, PICU)

  • R0043944
  • Charlottesville, Virginia, United States
  • Research
  • The University of Virginia
The Department of Pediatrics at the University of Virginia (UVA) School of Medicine seeks a candidate for a Clinical Research Coordinator 3 or 4, non-licensed or licensed, to assist with oversight of intensive care clinical trials. The successful applicant will work primarily on clinical trials conducted in the Neonatal Intensive Care Unit (NICU) and will assist Investigators in Pediatric Intensive Care Unit (PICU) to support and expand the current PICU clinical research program. A Clinical Research Coordinator - 3 or 4 will be expected to plan, organize, lead, and perform comprehensive and advanced-level clinical research duties for multiple and/or complex clinical trials. Our preferred candidate for this position will have the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate. The CRC in this role will be able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective department or division to meet the needs of a given study in collaboration with the manager of the team. As a key member of the research team, you will work closely with the Clinical Research Operations Manager as well as physicians in both the NICU and the PICU. This position requires the ability to work rotating weekends and on-call shifts, alternating with others within the department, as needed for study requirements. The successful candidate will be required to manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain all study documentation in a manner that is ‘audit ready’.

The successful candidate will be expected to:
  • Screen electronic medical records (EMR) for potential study candidates and track screening efforts.
  • Recruit and obtain informed consent from study participants and maintain telephone and in-person contact.
  • Manage ongoing study conduct activities such as: coordinate study treatment, maintain concomitant medication records, track and report adverse events, organize subject study payments.
  • Work closely with Principal Investigators (PI) and other study team members on clinical research projects assigned.
  • Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
  • Work well with minimal supervision
  • Facilitate and / or complete activities required for study start-up including: regulatory submissions and all communications with the study Sponsor.
  • Coordinate multiple clinical trials or research projects simultaneously or manage large individual clinical trials that may be multicenter and complex in nature.
  • Manage all aspects of ongoing clinical trial conduct from enrollment to off-study visits, data management, safety reporting and compliance oversight.
  • Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, and unanticipated events.
  • Support investigator initiated research activity including: study feasibility assessment, clinical trial protocol development, compliance oversight and study conduct.
  • Reconcile study billing, identify study charges, versus payments to the subject or third-party vendor
  • Orient, train and mentor to new study team members.
  • Ensure Sponsor is invoiced for study activity and reconcile payments received.
  • Notify PI and/or Clinical Research Operations Manager of potential issues with the study or subject status.
  • Communicate effectively with study Sponsor(s).
  • Liaise with the other Departments within the institution to support clinical research activities.
  • Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.
  • Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.
  • Process, prepare and ship study research samples
  • Ability to work a flexible schedule, when needed, given the nature of the studies open to enrollment
  • Ability to work on weekends, when needed, given the nature of the studies open to enrollment
  • Support and providing guidance to faculty and trainees with clinical research projects in the department.
  • In addition to the above job responsibilities, other duties may be assigned.


Qualified candidates must have:

Clinical Research Coordinator 3, Non-Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
Experience: Minimum of three years of clinical research experience required. Master’s degree may substitute for one year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Clinical Research Coordinator 3, Licensed

Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse.
Experience: A minimum of three years of clinical research experience required. Master’s or advanced degree may substitute for one year of clinical research experience.
Licensure: Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy.

Clinical Research Coordinator 4, Non-Licensed

Education: Bachelor's degree required, Master’s or other advanced degree preferred.

Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master’s or other advanced degree may substitute for one year of clinical research experience.

Licensure : Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Clinical Research Coordinator 4, Licensed

Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse.
Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master’s or other advanced degree may substitute for one year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required. Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy.

Preferred experience:
  • Previous experience with EPIC EMR, collection and processing of blood draws for research.
  • Previous experience with OnCore, Advarra, and WCG IRB.
  • Previous experience managing several open clinical trials at the same time.


Required knowledge, skills and abilities:
  • Excellent interpersonal and communication skills.
  • Ability to work independently and as part of a team.
  • Ability to prioritize competing tasks and take initiative.
  • Ability to plan and execute project and keep the study team up to date.
  • Effective use of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
  • Previous experience with EPIC EMR, collection of biomarkers such as blood draws, and experience in a clinical environment.
  • Strong analytical skills.


Physical demands: This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.

The Clinical Research Coordinator 3 or 4 will report to the Clinical Research Operations Manager. For additional information about the position, please contact Monika Thielen, ART, BComm, CCRP at mjt3c@virginia.edu .

This position is located in Charlottesville, VA. This position is a restricted position and is dependent upon project need, availability of funding and performance. This is an exempt-level, full-time, benefited position. For more information on the benefits at UVA, visit www.hr.virginia.edu/benefits.

The position will remain open until filled. This position will not sponsor applicants for work visas. The anticipated hiring range is commensurate with education and experience.

The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen and drug screening are required for this position prior to employment.

To Apply:
Process for Internal UVA Applicants: Please apply through your Workday Home page, search “Find Jobs”, and search for R0043944.
Complete an application online with the following documents:
• CV
• Cover letter
Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

Process for External Applicants: Please visit UVA job board at https://uva.wd1.myworkdayjobs.com/UVAJobs and search for R0043944.
Complete an application online with the following documents:
• CV
• Cover letter
Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

References will be completed via UVA’s standardized process Skill Survey. A total of five references will be requested via SkillSurvey during the final phase of the interview process.

For questions about the application process, please contact Christi Maguire Recruiting Specialist, at clm8sd@virginia.edu , please reference job requisition R0043944.

For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/ .

The University of Virginia School of Medicine and affiliated UVA Health form the premier medical and research institution in the Commonwealth of Virginia and have a rich tradition of discovery, translational, clinical and health services/outcomes-based research grounded in a culture of collaboration and service. Three Nobel laureates have called UVA their home. The University is located in Charlottesville, VA, situated in the Blue Ridge Mountains and picturesque Shenandoah Valley just 100 miles from Washington, DC. Our region boasts outstanding opportunities for outdoor recreation year-round, including hiking, water-based activities and skiing. Virginia Beach and other types of costal recreation are also accessible. For more information about the Department of Pediatrics, please see: https://med.virginia.edu/pediatrics/ .

Employee benefits package highlights include:
  • 22 days of paid time off, increasing with service; 13+ paid holidays each year, in addition to paid time off; Parental and Community Service Leave
  • Health plan with options to meet healthcare and financial needs
  • Retirement through the Virginia Retirement System
  • Tuition and professional development benefits
  • Employee wellness program featuring activities to earn up to $500/year


COVID Vaccination Requirement and Guidelines

Please visitthe UVA COVID-19 Job Requirements and Guidelines webpageprior to applying for current information regarding vaccination requirementsandguidelines for employment at UVA.

The University of Virginia, i ncluding the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician’s Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.

 

Each agency within the Commonwealth of Virginia is dedicated to recruiting, supporting, and maintaining a competent and diverse work force. Equal Opportunity Employer

Sign up for job alerts

Not You?

Thank you

Share this job

Not You?

Thank you for sharing this job

Similar Jobs

Judicial Assistant to the Deputy Commissioner

VA Workers' Compensation Comm 495751 HARRISONBURG Virginia United States 136 W ELIZABETH ST SUITE 101, HARRISONBURG, Virginia, United States, 22802 VA Workers' Compensation Comm Administrative Services
Led by a Senior Leadership team consisting of three Commissioners, an Executive Director and a Chief Deputy Commissioner, Virginia Workers’ Compensation Commission was recently recognized as a Top Workplace for 2021 in the Richmond region! Our mis...

Probation Officer Senior

Dept of Corr - Central Admin 495367 MANASSAS Virginia United States 9309 CENTER STREET , MANASSAS, Virginia, United States, 20110 Div of Community Corrections Public Safety
WHY VADOC? WHY NOT? ***Sign on Bonus Info. Here if Applicable** Job stability, 13 paid state holidays in addition to generous vacation, sick, personal leave and military leave incentive. Public Student Loan Forgiveness Program, Affordable health...

Probation Officer Senior

Dept of Corr - Central Admin 495150 MANASSAS Virginia United States 9309 CENTER STREET , MANASSAS, Virginia, United States, 20110 Div of Community Corrections Public Safety
WHY VADOC? WHY NOT? ***Sign on Bonus Info. Here if Applicable** Job stability, 13 paid state holidays in addition to generous vacation, sick, personal leave and military leave incentive. Public Student Loan Forgiveness Program, Affordable health...

Advancement Associate - College of Architecture, Arts, and Design (AAD)

Virginia Tech University 524515 Blackstone Virginia United States Virginia, United States. Blackstone, Virginia, United States, 23824 Dean - Architecture Administrative / Clerical, Advancement
Help us build the future! Join the College of Architecture, Arts, and Design's advancement team and provide fundamental support in the areas of administrative and stewardship management

Attorney - Assistant Public Defender I/II - Prince William

Indigent Defense Commission 495760 MANASSAS Virginia United States 7900 SUDLEY RD 7TH FL, MANASSAS, Virginia, United States, 20109 Indigent Defense Commission Administrative Services
The IDC is committed to inclusive hiring and dedicated to diversity in our workforce. We encourage and welcome qualified applicants of all identities, cultures, backgrounds, and experiences. Join the team!

Apply Now

Not You?

Thank you