Clinical Research Supervisor (Breast / Gyn)

University of Colorado•Aurora, CO

7d•Hybrid

About The Position

As an important member of the research team, the Clinical Research Supervisor will report to the team manager. This position works with Phase I-IV industry-sponsored, co-operative group and or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. It is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. This position is responsible for coordinating study subject appointments throughout the study as well as scheduling, coordinating, and preparing for monitoring visits and audits. The incumbent is responsible for data entry and resolution, study subject advocacy; and possible management of studies at the local level.

Requirements

Bachelor’s degree in Science, Health, Business or Finance, Mathematics, History, Social Sciences, Arts, Communications, Education, Engineering, Human Services, Legal, or related fields
Two (2) years of clinical research experience and one (1) year of clinical or clinical research experience.
Applicants must meet minimum qualifications at the time of application.
Knowledge of and experience with basic human anatomy, physiology, and medical terminology.
Intermediate to Advanced Microsoft Office skills (Excel, Word, Outlook).
Experience working with an assortment of electronic CRF software programs
Experience with Sponsors and Audits
Analytical Skills - Ability to interpret and master complex research protocol information.
Attention to Detail – Excellent attention to detail and ability to interpret and master complex research protocol information
Complex Problem Solving – Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
Interpersonal Skills – Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality.
Customer Service – Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
Adaptability – Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team.
Planning and Organizing – Sets priorities, anticipates obstacles when planning ahead, manages time effectively to accomplish tasks.
Technical Skills – Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.

Nice To Haves

Oncology research experience
Additional certification (one of the following): CCRC – Certified Clinical Research Coordinator CCRP – Certified Clinical Research Professional CCRA – Certified Clinical Research Associate

Responsibilities

Under Manager’s guidance, arranges orientation and provides training, supervision and leadership to the clinical research staff.
Assigns patient and trials to staff with guidance from Clinical Research Manager.
Supervises team vacation, out of office coverage, time management of direct reports.
Plans and directs investigator and coordinator meetings including but not limited to team meetings, initial orientations, study audits, and closeout visits.
Under Manager’s guidance, makes recommendations regarding clinical research personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions.
Participates in reviewing and tracking deviation trends leading to review of processes.
Performs quality assurance checks by reviewing patient shadow charts, monitor letters, audit results, OnCore entry, data entry.
Performs quality assurance checks by reviewing patient shadow charts, monitor letters, audit results, OnCore entry, data entry.
Supervisor Meetings – Attend and bring items from team to meeting and provides updates back to team.
Maintain 2-5 study participants at any given time and management of day-to-day issues such as scheduling conflicts, infusion issues, enrollment packet review under the direction of the CRM if problems escalate