Key Responsibilities:
In collaboration with the Gates Institute management, provides leadership, and
oversight for operations of Gates Institute trials by coordinating across functions and systems to optimize the trial process.
Provides leadership for the formulation of the clinical trial education program, including setting strategic direction and
ensuring business standards and objectives are met.
Provides education to site teams and other stakeholders on Gates
Institute clinical trial protocols and standardized processes.
In collaboration with Gates Institute Medical Lead(s),
verifies patients meet all eligibility criteria; verifies and reviews adverse events, serious adverse events, and other trial data, and
ensures accurate reporting in accordance with the protocol.
Assists in resolving problems, acting as a liaison between the
research team and other institutional stakeholders and ensuring timely communication and appropriate escalation of unresolved
obstacles.
Tracks, documents, and updates stakeholders on condition of study participants.
Assists in the
development of trial protocols and amendments.
Supports in the compilation and review of Investigational New Drug (IND)
submissions/reports, Safety Monitoring Committee (SMC) reports, and IRB submissions as needed.
Identifies, tracks and
analyzes barriers in current clinical trials processes and recommends process improvements.
The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more
every day. They are only limited by their resources and need you to make their journey a success!
In addition to the amazing benefits
offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients.
CU’s Benefits: https://www.cu.edu/employee-s
ervices/benefits
The University of Colorado offers a comprehensive benefits package that includes health insurance, life
insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are
available, please visit: https://www.cu.edu/
employee-services/benefits-wellness.
A bachelor’s degree in business, business administration, finance, accounting, education, social
sciences, physical/biological sciences, engineering, healthcare administration, public administration, communications, information systems,
or a directly related field from an accredited institution. Substitution: College or university course work appropriate to the work
assignment may substitute for the experience on a year-for-year basis.
At least 6 years of professional level experience in
clinical trial operations, with at least 2 years of experience specifically with gene therapy or cellular therapies.
At least 2 years of demonstrated team leadership experience.
Must have a registered nurse license
(RN).
Applicants must meet minimum qualifications at the time of hire.
Preferred
Qualifications:
Master’s degree in a related field from an accredited college or university.
Experience submitting Investigational New Drug (IND)
applications
Professional clinical research experience in an academic medical center.
Experience providing,
supervision, mentorship, and training.
Knowledge, Skills and Abilities:
Strong critical
thinking and problem-solving skills required.
Exceptional communication and interpersonal skills, both oral and written
Excellent multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced
environment
Ability to learn quickly and understand new technical concepts and processes
Flexible and able to
adapt to program growth and evolving responsibilities
Self-motivated and able to work in a team environment
Able to work well under pressure, especially when assisting involved stakeholders
Proficiency in Microsoft Suite
(especially Excel, PowerPoint, Word, and Project).
A strong working knowledge of Good Clinical Practices (GCP), U.S. Food
and Drug Administration (FDA) rules and regulations in relation to clinical trials, National Institutes of Health (NIH) guidelines,
International Council for Harmonisation (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) regulations in
relation to clinical trials, and other universally accepted practices and procedures within clinician trial management.
1. A
letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
2.
Curriculum vitae / Resume
3. Three to five professional references, including name, address, phone number (mobile number if
appropriate), and email address
Questions should be directed to: Donna Parker at [email protected]
The above salary range represents the University’s good faith and reasonable estimate of the range of
possible compensation at the time of posting.
This position is not eligible for overtime compensation.
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: http://www.cu.edu/node/153125
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