Professional Research Assistant
University of Colorado - School of Medicine
Professional Research Assistant
CU Sports Medicine provides comprehensive care for sports and related injuries to competitive and recreational athletes of all types and ages. We have four clinics located in Boulder, Denver, on the Anschutz Medical Campus, and in Lone Tree.
The CU Sports Medicine Clinical Research Regulatory Compliance Manager will provide comprehensive oversight for all clinical research activities across CU Sports Medicine's clinic and surgical sites, including all regulatory management, to ensure regulatory compliance and successful conduct of all clinical research. The position will also provide clinical coordination and data collection support as needed.
Examples of Work Performed:
- Manages a comprehensive clinical research program, working collaboratively with researchers, Sponsors, IRBs, research and clinic staff, as well as other UCD and UCH departments to operationalize CU Sports Medicine research protocols.
- Prepares and submits all documents required for all IRB submissions, as well as other submission required by UCH, UCD, CTRC, FDA and other agencies throughout the protocol life cycle.
- Assures regulatory compliance and adherence to all research standards as set forth by the FDA, OHRP, GCP, ICH, UCD, UCH, COMIRB, and other related local and federal agencies.
- Oversees, trains, and supports PRAs in the daily conduct of clinical research, ensuring patient safety and data integrity.
- Oversees financial aspects of protocols, including collaboration of budget development, proper invoicing, and study subject payments.
- Prepares for and participates in Quality Assurance Reviews, as well as internal and external audits.
- Develops training materials and conducts overall and study specific training of all research personnel.
- Develops guidance documents, templates, and facilitates process improvement and best practices.
- Prepares information and presentations for and conducts monthly research meetings and annual research retreats.
- Provides clinical coordinator support as needed for consenting, scheduling, data collection and patient follow-up.
- Provides data management support as needed for web based Patient Reported Outcomes (PRO) data collection system.
- Establishes and maintains efficient and effective communication between all entities and individuals involved in the research process.
- Bachelor's degree or equivalent in a health related field.
- 2 years' experience in clinical research
Required Competencies/Knowledge, Skills and Abilities:
- Outstanding organizational and time-management skills
- Excellent oral and written skills with the ability to communicate effectively and efficiently
- Excellent interpersonal skills including the ability to develop solid rapport with others
- Ability to collaborate with a variety of investigators and individuals in a respectful, problem solving manor
- Experience managing all aspects of a clinical research program in an academic setting
- ACRP or SoCRA certification
- Master's degree in a health related field
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.
Special Instructions to Applicants:
Review of applications will begin immediately, and will continue until the position is filled.
Questions should be directed to Jessie.Larson@ucdenver.edu
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 09378
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: H0001 -- Anschutz Medical Campus - 20259 - SOM-Orthopedics
Posting Date: May 2, 2017
Closing Date: Ongoing
Posting Contact Name: Jessie Larson
Posting Contact Email: firstname.lastname@example.org
Position Number: 00621549