Research Project Associate
Job location: Charlottesville, VA
Employment Type: Full-time
Posted data: 2019-07-26
The Clinical Trials Office (CTO), at the University of Virginia School of Medicine, is seeking a Research Project Associate. The CTO offers a variety of services to clinical research staff at UVA including CRC mentoring, protocol development and preparation, continuing education, and multi-center study management. These services are made available to SOM investigators and coordinators to promote the smooth and efficient conduct of their research studies.
The Research Project Associate is a member of the multi-center study management team who supervises, monitors and supports the administration, conduct, and progress of clinical trials at multiple participating institutions on behalf of the lead investigator at UVA. The incumbent is responsible for monitoring the regulatory activities and documents, data, and timelines/milestones of assigned clinical studies and developing strategies for staying on track. The incumbent is responsible for ensuring that study personnel at all study sites conduct the applicable studies according to the clinical protocol, current Good Clinical Practices governing clinical research, and all applicable regulatory requirements.
The Research Project Associate will ensure that major milestones are achieved, under the oversight of a Project Manager. The Research Project Associate will work with a degree of independence, but under supervision.
The successful candidate will have a Bachelor's Degree in a relevant discipline. Significant relevant experience may be considered in lieu of a degree. A Bachelor's Degree in a science-related field is preferred. A minimum of 2 years of clinical research experience is required. Additional experience may be required in lieu of Bachelor’s Degree. Prefer 2-4 years of experience as a Clinical Research Coordinator (CRC), Clinical Research Associate (CRA) and/or Research Project Associate. Prefer Registered Nurse (RN).
Salary will be commensurate with experience and education.
This is a restricted position. This continuation of this position is contingent upon the availability of funding.
For more information regarding this position, please contact Lori Elder, Director, SOM Clinical Trials Office, at [email protected] .
EXTERNAL APPLICANTS: please apply through Workday at the following URL, https://uva.wd1.myworkdayjobs.com/UVAJobs , and search for requisition # R0008343. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, address).
INTERNAL UVA APPLICANTS: please apply through your Workday Home page, search “Find Jobs”, and search for requisition # R0008343. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, address).
Research Project Associate Responsibilities will include:
1. Project Management [approximately 50% of time]:
- Assist PI in incorporating multi-center requirements/aspects into a developing protocol.
- Assist in identifying potential sites. Perform feasibility assessments.
- Work with Database Manager, as applicable, to develop protocol calendar and data forms. Modify forms when necessary as study evolves.
- Develop Trial Master File (sponsor files and investigator files).
- Develop project timelines and provide study metrics to assist in the management of the study. Track, measure and report progress to overall and participating PIs.
- Receive and report SAE/DLT information to the study sponsor. Prepare and submit reports to the FDA, drug manufacturer and/ or participating sites, as applicable.
- Assist in the collection of information required by the UVa DSMC (for oncology protocols) and/or a DSMB for other protocols. Prepare and disseminate necessary reports to the committee/board as well as the drug manufacturer and/ or participating sites, as applicable.
- Draft and disseminate protocol and/or informed consent modifications to participating sites. Track IRB review and approval process.
- Organize and lead applicable study team meetings and draft meeting minutes. (A)
- Oversee process for site personnel to access study database including (but not limited to), site risk management assessment, token management (including external user VPN access to Health System and Academic servers, split-tunnel exemptions, and account creation / renewal), and database training.
- Invoice sponsor per achieved milestones. Receive and reconcile site invoices, request and track site payments.
- Oversee study posting on Clinicaltrials.gov.
2. Study Monitoring and Management [approximately 40% of time]:
- Review and confirm subject eligibility for study participation. Register and randomize when applicable.
- Facilitate completion, collection, maintenance and management of all regulatory documents required from participating sites.
- Participate in the development of processes, when applicable, to ensure adequate study drug supply at each participating study site.
- Monitor investigator conduct at all assigned participating sites, ensuring compliance with all applicable regulations and guidelines.
- In accordance with the monitoring plan/guidelines developed for each study, conduct source document verification of data submitted by the study sites, ensuring the quality, integrity and validity of the data collected.
- Generate, disseminate, track and process data queries.
- Conduct regulatory review of signed informed consent forms.
- Conduct drug/device accountability review when applicable.
- Monitor study site regulatory documents. (A)
- Ensure study staff at participating sites is following the approved protocol and adhering to all applicable regulations/guidelines (e.g., FDA, ICH).
- Perform close-out activities for each site upon study completion.
- Document and report the status and findings from monitoring activities.
- Report monitoring findings to lead PI and, as appropriate, collaborate to develop remediation plan.
- Perform initial and continuing training for study personnel.
- Manage process for collection and shipment of site deliverables (blood and tissue samples, radiologic studies).
3. Study Start-Up [approximately 10% of time]:
- Develop study-related documents, including (but not limited to), study protocol, informed consent template, Manual of Procedures, Case Report Forms, monitoring plan/guidelines, Pharmacy Manual, Lab Manual.
- Develop electronic tools to be utilized for the study (Training slides, Study Website).
- Identify, request, facilitate collection of all required regulatory documents required in the conduct of the assigned studies.
- Serve as the liaison between the sites and lead PI (or other assigned personnel) in the negotiation of site budgets.
- Serve as the liaison between the sites and UVa Grants and Contracts Office in the negotiation and execution of contracts.
- Serve as the liaison between the sites and UVa IRB to develop and implement Reliance Agreements for multicenter studies using UVa as the IRB of Record.
- Prepare agenda and supporting information/documentation for site initiation visit (SIV).
- Serve as the point of contact for the site study staff for all study start-up related
4. Additional responsibilities/duties as assigned:
Education: A Bachelor's Degree in a relevant discipline is required. Significant relevant experience may be considered in lieu of a degree. Bachelor's Degree in a science-related field is preferred.
Experience: A minimum of 2 years of clinical research experience is required. Additional experience may be required in lieu of Bachelor’s Degree. Prefer 2-4 years of experience as a Clinical Research Coordinator (CRC), Clinical Research Associate (CRA) and/or Research Project Associate. Prefer Registered Nurse (RN).
Required Knowledge, Skills, and Abilities:
1. Interpersonal and written communication skills.
2. Basic keyboarding skills.
3. Ability to multitask and prioritize.
4. Ability to manage several competing activities simultaneously.
5. Strong organizational skills.
6. Working knowledge of state and federal guidelines as they apply to the conduct of clinical research.
7. Knowledge of GCPs governing clinical research.
8. Ability and willingness to learn new software programs.
9. Proficiency with Microsoft Office (Word, Excel and Outlook.
10. Prefer experience with the following computer applications: OnCore, other clinical trial management system, electronic data capture system.
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require walking some distance to attend meetings, and programs.The University of Virginia, including the UVA Health System and the University Physician’s Group 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, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.