Sr Professional Research Asst
University of Colorado - CCTSI
Senior Professional Research Assistant
The full time Clinical Research Associate will be a key member of the Clinical Research Support Team (CReST). CReST is part of Colorado Clinical and Translational Sciences Institute, which aims to translate basic science knowledge into clinically useful treatment for patients. CReST provides support to investigators for all activities related to the successful conduct of clinical research, from study start-up through close out, under a fee for service model. This position will focus on developing a clinical monitoring program and providing direct monitoring services for investigator-initiated studies, particularly those studies where the local researcher is the sponsor/IND holder. This position will also act in a study coordinator role to support the work load of the team.
Examples of Work Performed:
* Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
* Assists research teams to develop appropriate monitoring plans based on the complexity of the study.
* Assist with the development of eCRFs or appropriate database resources for data capture
* Monitors data compliance, reporting findings to the study's principal investigator (PI).
* Ensures quality of study data through identification, evaluation and resolution of discrepancies and other efforts to reduce data errors by researchers.
* Relays timely information to PI's, study staff, and CReST
Serve functions as a clinical research coordinator for industry, federal or locally funded clinical studies, including:
* Conducting the informed consent process, and ensuring proper documentation.
* Reviewing protocol inclusion/exclusion criteria to confirm study eligibility.
* Recruiting prospective participants and conducting data collection visits for multiple clinical studies. Contacting potential participants with the details of the study via phone and in-person interviews.
* Working with the manager to coordinate scheduling of participant and monitoring visits.
* Recognizing adverse events and prompt notification of appropriate parties.
* Other duties as assigned by manager
Salary and Benefits:
The hiring salary for this position is $55,000 to $75,000 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.
Bachelor of Science or equivalent degree
Two years clinical research and / or monitoring experience
* Previous Epic EMR training
* Bi-lingual (Spanish & English)
Competencies / Knowledge, Skills and Abilities:
* Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
* Data management
* Superior communication and organizational skills
* Ability to work independently following training
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 12836
When applying, applicants must include:
- A letter of application which specifically addresses the job requirements and outlines qualifications
- A current Resume/CV
- 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 do not submit any of your application material (via email) to the job posting contact.
Job Category: Faculty
Primary Location: Aurora
Department: U0001 -- Denver-Anschutz Administration - 60120 - ADM-VCR CCTSI GenOps
Posting Date: Mar 5, 2018
Closing Date: Ongoing
Position Number: 00743999