Senior Professional Research Assistant- MFM





University of Colorado - School of Medicine

Senior Professional Research Assistant

The SR PRA position is designed to work within the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology to assist with activities required to perform clinical protocols in the areas of maternal fetal medicine, specifically pregnancy smoking and electronic cigarette use.

Initially, the SR PRA will assist with obtaining necessary study approvals, which include assisting with protocol drafts and forms. Once approval has been granted the SR PRA will be responsible for providing necessary information for yearly reviews by both COMIRB and funding sources.

Additionally the SR PRA will assist with local practice outreach and study education. Maintaining such relationships will be important for study enrollment and execution. To prepare for study enrollment the SR PRA will assist in designing and maintaining standard operating procedures, data collection forms, and database layouts. During the enrollment phase, the role of the SR PRA will be to perform patient screening and recruitment into the NIH funded study.

Specific duties include: Reviewing protocol inclusion/exclusion criteria, obtaining informed consent, obtaining medical history, and conducting study interviews. The SR PRA will ensure that the informed consent process has occurred, is properly documented and filed as required. The SR PRA will familiarize potential subjects with the details of the study through phone contacts and personal interviews and will schedule subject participation in research, coordinate availability of necessary space, and clinical support (including but not limited to physician, nurse practitioner, laboratory, radiology, pharmacy). The SR PRA will also accurately record the relevant information on data forms, perform data entry, and data queries. The SR PRA will coordinate patient follow-up data and scheduling clinic visits. Finally, the SR PRA will be responsible for coordinating study activities with other study sites in the Northeast U.S. via emails, phone calls, and video conferencing.

The position will primarily be based at the Anschutz campus, but will require travel to other hospital sites in the Denver metropolitan area.

Professional Field:

The SR PRA should be attentive to detail, have excellent interpersonal communication, organizational skills, ability to problem solve and multi-task, and be able to complete all required documentation (either manual or electronic) as required by the studies being performed. Prior certification by Colorado Multiple Institutional Review Board (COMIRB) is desired. The SR PRA will also be trained in electronic medical charting at all hospitals where the studies are being conducted (EPIC at University Hospital).

Supervision Received:

The SR PRA will be supervised by the study site Principal Investigators (PI). Formal discussions with the SR PRA/PI will be held on a regular basis, frequency will depend on individual's background and clinical research experience - however, ad hoc discussions virtually every day. Additionally group meetings including local study personnel, and virtual meetings with study personnel at other sites will also be held regularly.

Supervision Exercised:

The SR PRA will be responsible for supervising any additional hires, as well as any study volunteers and research assistants. Formal discussions between the SR PRA and other staff will occur on a regular basis.

Examples of Work Performed:
  • Supervise other staff
  • Train new staff on daily activities including: data management, data collection, data analysis, scheduling visits, consenting patients, and ensuring that staff are appropriately on-boarded at outlying sites such as UCH and CHCO
  • Work with the OB/GYN Research Regulatory Manager to draft and submit necessary study approvals including: drafts, revisions, amendments, and any new protocols.
  • Complete semi-annual reviews required by both COMIRB and funding sources
  • Assist with the coordination and execution of local OB/GYN practice outreach and study education.
  • Design and maintain standard operating procedures, data collection forms, and database layouts
  • Subject screening, recruitment, consenting at multiple clinical sites
  • Data collection, data entry and data analysis
  • Conduct follow-up phone interviews, schedule clinic visits
  • Assist with collection and processing of samples collected for research
  • Work with CTRC and other research/hospital personnel to assure studies are being conducted properly at each enrollment site.
  • Ensure the maintenance of research folders/checklists, and keep datasheets up to date at each enrollment site
  • Create and maintain study binders, excel follow-up spreadsheets, orientation packet, regulatory binder, etc for each enrollment site.
  • Maintenance of study specific certifications, COMIRB training, computer training and other hospital required training
  • Attend and coordinate regular large group and small meetings
  • Serve as the contact for and assist collaborators in data collection, entry and analysis as needed
  • Serve as the contact for administrative issues with collaborative entities including UCH and CHCO
  • Maintain a working budget, make purchases as necessary, and meet regularly with the DRS administrator about charges and spending relating all grants
  • Prepare and assist in the preparation of abstracts and publications

Knowledge, Skills and Abilities:

Careful attention to detail and the ability to interact well with both clinical research subjects and other health professionals is necessary to succeed in this position. The SR PRA will not be called on to make medical decisions at any time. A solid fundamental knowledge of clinical health sciences is desired. The individual must be able to utilize computers for communication, data entry and completion of clinical reporting forms as required.


Qualifications


  • A Master's level degree in public health, psychology, or other health-related field, with a fundamental knowledge of clinical research required.
  • Computer knowledge and the ability to use electronic medical records are necessary.

Salary and Benefits:

Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.

The University of Colorado Denver is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

The University of Colorado strongly supports the principle of diversity. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.



Application Materials Required:Cover Letter, Resume/CV, List of References

Application Materials Instructions:

Applications are accepted electronically at CU Careers, refer to requisition ID: 10613

When applying, applicants must include:
  1. A letter of application which specifically addresses the job requirements and outlines qualifications
  2. A current Resume/CV
  3. The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please be advised that the University does check references as part of the employment process.

Please do not submit any of your application material (via email) to the job posting contact.



Job Category: Faculty

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 21613 - SOM-OB/GYN MFM

Schedule: Full-time

Posting Date: Aug 7, 2017

Closing Date: Ongoing

Posting Contact Name: Chris Hodges

Posting Contact Email: christine.hodges@ucdenver.edu

Position Number: 00704251

PI98965929