Senior Professional Research Assistant
Professional Research Assistant
Division of Cardiology, Department of Medicine, School of Medicine
The Department of Medicine/Division of Cardiology is seeking applicants for a full-time Senior Professional Research Assistant (PRA) position for the Cardiology Clinical Trials Program.
This position will oversee the daily operations of the PRA's in conducting Clinical Trials in the Division of Cardiology
Duties include (not limited to):
- Development and management of a research matrix to monitor the progress of all Clinical Trials within the Division of Cardiology.
- Assessing feasibility and ongoing monitoring of clinical trial workload across the Division of Cardiology with the Division's Clinical Director of Research faculty member.
- Works alongside the Division's Clinical Trials Finance Manager for research subject payment for University of Colorado Hospital and its departments, and CU Medicine.
- Provides assistance to the Divisional Clinical Trials Finance Manager for budget development for upcoming clinical trials.
- Provides ongoing support for other research coordinators regarding UC Denver's research processes and study-specific procedures.
- Provides direction and support for subject recruitment, tracking of study visit schedules appointments.
- Training and mentoring of PRAs serving as clinical trial coordinators
- Study assignments and work load assessment.
- Conducts periodic audits of all the study documentation to ensure compliance and completeness.
- Provides training and support to PRA's for query resolutions.
- Works directly with industry sponsors monitors to ensure completeness of all work submitted.
- Troubleshoots database resolution.
- Has the ability to monitor and track data entry, subject screening and enrollment activities and troubleshoot areas where needed for compliance.
- Develops and submits accurate IRB applications, Continuing Review Reports and all other required documents to support the conduct of clinical trials research.
- Formulates consent documents in accordance with IRB regulations and sponsor-specific requests.
- Assists with the drafting of protocols, case report forms, and other required documents for Investigator Initiated trials.
- Serves as a clinical research coordinator when needed.
- Master's Degree or work equivalent in areas of clinical research management
- Minimum of three years full-time research experience in most of the areas mentioned.
- Must have detailed knowledge of Good Clinical Practice (GCP) /ICH guidelines in clinical research.
- Candidates with additional research experience in most of the areas mentioned, with excellent communication and organizational skills, and an ability to work independently, are highly desirable.
Salary & Benefits:
Salary is negotiable and commensurate with skills and experience.
The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services.
The University of Colorado Denver | Anschutz Medical Campus 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 Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. 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:Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 5 references if you are referred to the Hiring Authority for interview. We will notify you prior to contacting both on and off-list references.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 12305
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 - 20169 - SOM-MED-Cardiology
Posting Date: Jan 10, 2018
Closing Date: Ongoing
Posting Contact Name: Dennis Evans
Posting Contact Email: firstname.lastname@example.org
Position Number: 00623443