- 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 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.
- 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.
- 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.
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Clinical Research Coordinator 2, 3 or 4, Department of Pediatrics UVA - Charlottesville, United States - University of Virginia
Description
The Department of Pediatrics at the University of Virginia (UVA) School of Medicine seeks a candidate for a Clinical Research Coordinator (CRC) 2, 3 or 4, non-licensed or licensed, to work in Developmental Pediatrics.
The successful applicant will work primarily on clinical trials focused on Autism.The CRC in this role will be expected to plan, organize, lead, and perform comprehensive and advanced-level clinical research duties for multiple and/or complex clinical trials.
A CRC 3 or 4 hired in this role will be able to work well independently, while a CRC 2 may require guidance and mentorship.
The CRC will 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.
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'.
As a key member of this research team, you will work closely with the Investigators and staff in Developmental Pediatrics as well as Investigators and staff from other Departments or organizations involved autism research.
The division of Development Pediatrics is a member of the Autism Care Network which is an important platform that connects people with autism to accelerate research and improve care.
For more information:
The UVA Department of Pediatrics and the UVA Children's Hospital share a common goal to enhance the health and well-being of children and families through collaborative medical care, education of professionals dedicated to pediatric healthcare, breakthrough research that improves lives, leadership, and community service.
The successful candidate will be expected to:
Qualified candidates must have:
Clinical Research Coordinator 2, Non-Licensed
Education:
Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
Experience:
At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
Clinical Research Coordinator 2, 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 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 3, Non-LicensedEducation:
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:
Licensure:
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.
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:
Licensure:
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Licensed to Practice as a Registered Nurse.
Clinical Research Coordinator 4, Non-Licensed
Education:
Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
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:
Licensure:
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.
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:
Licensure:
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.
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:
Required knowledge, skills and abilities:
Physical demands:
This is primarily a sedentary job involving extensive use of desktop computers. The job occasionally requires traveling some distance to attend meetings, and programs.
The Clinical Research Coordinator will report to the Clinical Research Operations Manager.
For additional information about the position, please contact Monika Thielen, ART, BComm, CCRP at:
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 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 "R0045336".
Complete an application online with the following documents:
Process for External Applicants:
Please visit UVA job board at and search for "R0045336".
Complete an application online with the following documents:
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 ; please reference R
For more information about UVA and the Charlottesville community please see and
The University of Virginia, including 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.
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.
