Clinical Trials Manager
University of Colorado - School of Medicine
Clinical Trials Manager - 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.
This position will lead and manage multiple industry-sponsored pharmaceutical, NIH and investigator-initiated medical research studies under the direction of the Director of Kidney Transplant. Clinical, patient-care duties, visits and individual patient data management comprise approximately 60% of this position.
PRINCIPAL JOB DUTIES AND RESPONSIBILITIES/ESSENTIAL FUNCTIONS
- Lead and direct the Clinical Trial Office. Oversee all clinical trial coordinators and administrative staff, including time cards, evaluations, compensation and coaching/counseling. Facilitate hiring, training and developing staff to accurately and effectively carry out medical research studies, ensuring staff is meeting all requirements related to their assigned studies (data entry, tracking of investigational product, compliance with all study protocols, procedures, amendments and processes for human subjects' protection and data integrity). Lead regular staff meetings and establish schedule for on-call duties. Assess and assign workloads to be divided among manager and coordinators. Develop departmental policies and procedures, as required. (Weighted 40%)
- Interface with all study sponsors, CROs, Medical Science Liaisons (MSLs), including the scheduling and oversight of monitoring visits, audits and site initiation visits. Coordinate with principal investigators and sub-investigators to enroll clinical trial patients. Work with the Finance and Regulatory Specialist on initial IRB submissions and development of investigational product management plans and study budgets. Routinely meet with monitors to reconcile data management issues. Ensure overall compliance with policy and procedures for conducting good clinical trials. Research, recruit and assess new study potentials. (Weighted 10%)
- Screen, obtain consent and enroll study participants. Conduct study visits; provide patient education and follow-up. Assess adverse drug reactions and other serious adverse events. Collect, process and store laboratory samples for research. Confirm compliance with medication tracking, protocols and procedures. Abstract data from patient charts and electronic medical records. Enter data into research databases. Prepare source documents and build databases (as needed) for new studies. Work with other departments, such as OnCore, UCHealth, CTRC, to build calendars, plan billings and convey study details. (Weighted 50%)
ESSENTIAL FUNCTION REQUIREMENTS
Demonstrated skills: Critical thinking, effective problem solving and decision making; strong interpersonal, oral and written communication skills, with emphasis on customer service and consensus building; good recordkeeping and organizational skills.
Ability to: Work under pressure in a fast-paced research environment; prioritize diverse activities and demonstrate flexibility and adaptability in responding to unanticipated events; assimilate and analyze large quantities of information and recognize substantive items when making decisions and recommendations; handle and protect confidential/sensitive information.
Member of a centralized clinical trials unit that is team-oriented. Work is primarily in an office environment with frequent visits to hospital or clinical settings to meet with study patients for the purpose of enrollment or follow-up/monitoring; may occasionally work beyond regularly scheduled hours; on-call duties are required at least one full week per month; occasional travel may be required.
A variety of internal and external administrative staff and study patients, including but not limited to employees, physicians, patients, study participants, pharmaceutical sponsors and monitors.
DECISION MAKING AND COMPLEXITY
Independent, complex decision-making abilities. Manage and prioritize staff resources that support the timely and accurate administration and delivery of medical research studies, while complying with relevant laws, regulations and policies. Ability to assess and balance business needs and competing resources with associated costs/benefits.
POSITION IN ORGANIZATION
Position ultimately reports to: Director of Kidney Transplants.
Number of employees directly supervises: up to 4 clinical trial coordinators in the work unit.
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 or equivalent experience
Previous supervisory experience
Experience working in medical research and/or clinical trials
Five years of work experience in a clinic, hospital or clinical research setting
Knowledge of kidney disease and kidney transplant
ACRP or SoCRA certification
Special Instructions to Applicants:Review of applications will continue until position is filled, with priority given to those who apply before December 22nd, 2018.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 15285
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 - 20224 - SOM-MED-Renal General
Posting Date: Dec 4, 2018
Closing Date: Ongoing
Posting Contact Name: Betsy Pike, Human Resources Senior Professional
Posting Contact Email: [email protected]
Position Number: 00626228