Clinical Trials Manager
Company: University of Colorado
Posted on: January 14, 2019
University of Colorado -School of Medicine Clinical Trials Manager - Senior Professional Research Assistant The University of ColoradoDenver l Anschutz Medical Campus seeks individuals with demonstrated commitmentto creating an inclusive learning and working environment. We value theability to engage effectively with students, faculty and staff of diversebackgrounds. This position will lead and manage multipleindustry-sponsored pharmaceutical, NIH and investigator-initiated medicalresearch studies under the direction of the Director of Kidney Transplant.Clinical, patient-care duties, visits and individual patient data managementcomprise approximately 60% of this position. PRINCIPAL JOB DUTIES AND RESPONSIBILITIES/ESSENTIAL FUNCTIONS* Lead and direct the Clinical Trial Office. Oversee allclinical trial coordinators and administrative staff, including time cards, evaluations,compensation and coaching/counseling. Facilitate hiring, trainingand developing staff to accurately and effectively carry out medical researchstudies, ensuring staff is meeting all requirements related to their assignedstudies (data entry, tracking of investigational product, compliance with allstudy protocols, procedures, amendments and processes for human subjects'protection and data integrity). Lead regular staff meetings and establishschedule for on-call duties. Assess and assign workloads to bedivided among manager and coordinators. Develop departmentalpolicies 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 andsite initiation visits. Coordinate with principal investigators andsub-investigators to enroll clinical trial patients. Work with theFinance and Regulatory Specialist on initial IRB submissions and development ofinvestigational product management plans and studybudgets. Routinely meet with monitors to reconcile data managementissues. Ensure overall compliance with policy and procedures forconducting good clinical trials. Research, recruit and assess newstudy potentials. (Weighted 10%)* Screen, obtain consent and enroll studyparticipants. Conduct study visits; provide patient education andfollow-up. Assess adverse drug reactions and other serious adverseevents. Collect, process and store laboratory samples forresearch. Confirm compliance with medication tracking,protocols and procedures. Abstract data from patient charts andelectronic medical records. Enter data into researchdatabases. 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 studydetails. (Weighted 50%) ESSENTIAL FUNCTION REQUIREMENTS Demonstrated skills: Criticalthinking, effective problem solving and decision making; strong interpersonal,oral and written communication skills, with emphasis on customer service andconsensus building; good recordkeeping and organizational skills. Ability to: Work under pressure in afast-paced research environment; prioritize diverse activities and demonstrateflexibility and adaptability in responding to unanticipated events; assimilateand analyze large quantities of information and recognize substantive itemswhen making decisions and recommendations; handle and protectconfidential/sensitive information. WORKING CONDITIONS Member of a centralized clinical trials unitthat is team-oriented. Work is primarily in an office environment with frequentvisits to hospital or clinical settings to meet with study patients for thepurpose of enrollment or follow-up/monitoring; may occasionally work beyondregularly scheduled hours; on-call duties are required at least one full weekper month; occasional travel may be required. INTERNAL/EXTERNAL CONTACTS A variety of internal and externaladministrative staff and study patients, including but not limited toemployees, physicians, patients, study participants, pharmaceutical sponsorsand monitors. DECISION MAKING AND COMPLEXITY Independent, complex decision-makingabilities. Manage and prioritize staff resources that support the timelyand accurate administration and delivery of medical research studies, whilecomplying with relevant laws, regulations and policies. Ability to assessand balance business needs and competing resources with associatedcosts/benefits. POSITION IN ORGANIZATION Position ultimately reports to: Directorof Kidney Transplants. Number of employees directly supervises: up to 4 clinical trial coordinators in the work unit. Salary and Benefits: Salary iscommensurate with skills and experience. The University of Colorado offers afull benefits package. Information on University benefits programs, includingeligibility, is located at Employee Services. The Universityof Colorado Denver is dedicated to ensuring a safe and secure environment forour faculty, staff, students and visitors. To assist in achieving that goal, weconduct background investigations for all prospective employees. The ImmigrationReform and Control Act requires that verification of employment eligibility bedocumented for all new employees by the end of the third day of work.Alternative formats of this ad are available upon request for persons withdisabilities. Yourtotal compensation goes beyond the number on your paycheck. The University ofColorado provides generous leave, health plans and retirement contributionsthat add to your bottom line. Benefits: https://www.cu.edu/employee-services/benefits. TotalCompensation Calculator: https://www.cu.edu/employee-services/total-compensation Diversityand Equity: Pleaseclick here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx TheUniversity of Colorado Denver - Anschutz Medical Campus is committed torecruiting and supporting a diverse student body, faculty and administrativestaff. The university strives to promote a culture of inclusiveness, respect,communication and understanding. We encourage applications from women, ethnicminorities, persons with disabilities and all veterans. The University ofColorado is committed to diversity and equality in education and employment. QUALIFICATIONS Master'sdegree or equivalent experience PREFERRED QUALIFICATIONS Previous supervisory experience Experience working in medical research and/or clinicaltrials Five years of work experience in a clinic, hospital orclinical research setting Knowledge of kidney disease and kidney transplant ACRP or SoCRA certification
Keywords: University of Colorado, Aurora , Clinical Trials Manager, Healthcare , Aurora, Colorado
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