Sr Professional Research Asst
University of Colorado - School of Medicine
Senior Professional Research Assistant
The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.
Nature of Work
The Clinical Trials Manager (CTM) is responsible for recruiting and clinical trial preparation which may include the following: Ensure oversight and coordination of all activities related to clinical trials, assist principal investigators in study design and development, write protocols and informed consents, formulate and/or negotiate clinical trial budgets, IRB submissions, maintain regulatory compliance, route contract/clinical trial agreements/grants to the grants and contracts office, serve as the primary liaison between Clinical Research and Development and industry sponsors. The CTM will work closely with Principal Investigators, the department's administration, other departments and centers on campus and hospitals and clinics associated the University of Colorado Anschutz Medical Campus.
The CTM will provide support and leadership for studies that may involve industry-sponsored Phase I, II, Ill, and IV clinical trials. The CTM will have a close working relationship with the Vice Chair of Research and all other PIs, staff involved in studies. The CTM will ensure accurate progress of clinical research from the planning and approval stages through study completion and post-study closure. The CTM has responsibility of managing the overall financial aspects of clinical trials from inception to end. The CTM will be involved in hiring, training, and will supervise and act as a resource for clinical trials coordinators, PRAs and other trial study personnel. The CTM will delegate duties to coordinators as necessary. The CTM will assist in facilitating growth within the Department of Dermatology Clinical Research Unit.
Position reports directly to Vice Chair of Clinical Research and Director of Clinical Trials and Outcomes Unit, Department of Dermatology, University of Colorado Anschutz Campus.
May supervise up to 2 - Clinical Trials Coordinators
Examples of Work Performed
Initial study preparation
- Collaborates with principal investigators to assist in study design and development. This may include protocol development, conduct literature searches, survey or questionnaire development, formulate and/or negotiate budgets, arrange clinical trials space, provide clinical trials coordinators, and arrange services outside of the department as needed.
- Writes clinical trial protocols and informed consents.
- Serves as the primary liaison between Clinical Research and development and industry sponsors.
- Networks and collaborates with industry sponsors and PIs to facilitate new clinical trial opportunities.
- Attends investigator meetings for industry sponsored clinical trials.
- Completes and sends required documents to industry sponsors.
- Prepares protocol packages for IRB submission, and continues to provide necessary documentation to IRB throughout the approval process.
- Prepares all required research applications to individual hospitals and facilities as necessary
- Ensures that all IRB, hospitals and other facility approvals are in place prior to study initiation.
- Works closely with Grants and Contracts on all contracts/clinical trials agreements/grants. Prepares and routes all contract packages.
- Communicates and collaborates with the PI and the assigned clinical trials coordinator during the initial study preparation process.
- Continues working with the clinical trials coordinator on required IRB documentation throughout the trial.
- Maintains a tracking system of study related costs. Informs Business Services Director and PI of variations in funding to make adjustments as necessary.
- Works with department's administration and PIs to assure payments for study related costs are received and reconciled.
- Generates a monthly tracking report for each clinical trial.
- Responsible for renegotiating budgets as necessary, i.e. increase price of outside services, extension of studies.
Supervision of Clinical Trials personnel
- Is involved in the hiring of clinical trial coordinators and other trial study personnel.
- Trains clinical trials coordinators.
- Performance evaluations on clinical trials coordinator and other trial study personnel.
- Distribution of clinical trials within clinical trial coordinators and other trial study personnel.
- Delegate tasks to study personnel as necessary and appropriate.
- Maintains log of current trials and status
- Maintains access to all clinical trial portals including log in information
- Maintains contacts with study monitor and industry clinical trials liaisons
Facilitates growth for the Department of Dermatology Clinical Research and Development
- Actively seeks and participates in business development and expansion of services.
- Networks and/or collaborates within the Department of Dermatology, with other departments/campus groups, off campus groups and industry, in the acquisition of clinical research and clinical trials.
- Participation at specialty related annual meetings.
- Maintain a working relationship with current investigators.
- Contacts and recruits faculty within the department to be involved in research.
- Serves on committees both internal and external to increase exposure of the department's research program.
- Attends regular clinical trials meetings.
- Attends faculty meetings when 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 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.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator: https://www.cu.edu/employee-services/total-compensation
Diversity and Equity:
Please click here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx
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.
- Master's degree in biology or related field
- Prior clinical trials experience
- Knowledge in laboratory protocol
- Phlebotomy certified
- Prior experience conducting clinical trials
- 2 years of patient contact experience
Required Competencies/Knowledge, Skills and Abilities
- Ability to work long hours if needed
- Highly organized and reliable
- Strong interpersonal, communication, and writing skills
- Attention to detail a must as well as ability to accurately prioritize workflow
- Ability to work independently, within a strong team environment
- Ability to work closely within a strong team environment
- Ability to multi-task and manage competing priorities
- Excellent financial and analytical skills
- Experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook)
- Ability to understand complex organizations
- Must feel comfortable working with diverse populations
- Able to lift 50lbs
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 15262
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 - 20143 - SOM-Dermatology
Posting Date: Dec 3, 2018
Closing Date: Ongoing
Posting Contact Name: Kia Silverman
Posting Contact Email: [email protected]
Position Number: 00050363