Returning Candidate?

Clinical Trials Manager, Uganda

Clinical Trials Manager, Uganda

Job ID 
11135
Type 
Regular Full-Time
Company 
Fred Hutchinson Cancer Research Center
Location 
UG-Kampala
Category 
Clinical Research Support Services

More information about this job

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

Fred Hutch Global Oncology (GO), a Cross-Divisional program overseen by the Director’s Office at Fred Hutchinson Cancer Research Center, has a mission to generate cancer research that has global impact, and support the development of research capacity and clinical care to reduce the cancer burden in low-and middle-income countries.   A cornerstone of the program is a decade-long alliance with the Uganda Cancer Institute (UCI) that advances research, capacity building, and cancer care in Uganda. Fred Hutch operates in Uganda as the Hutchinson Centre Research Institute of Uganda (HCRIU).

 

This Kampala-based Clinical Trials Manager will report to the Deputy Head of Global Oncology and will work collaboratively with Fred Hutch and collaboration Principal Investigators, the Laboratory Director, Project Managers, Data Managers, Regulatory Affairs and Uganda based clinical staff to direct the daily clinical research activities of the Global Oncology program at the UCI-Fred Hutch Cancer Centre. An employee of the Hutch Centre Research Institute – Uganda (HCRI-U), the Clinical Research manager will oversee study operations across clinical projects, direct Program Managers and study clinical staff, and participate in mentoring of study nurses and other academic trainees. The Clinical Trials manager will coordinate with the Data Operations and Regulatory Affairs staff to assist in and monitor timely routine reporting, and will be responsible for coordinating program reports for activities at the HCRI-U for the Global Oncology leadership.

Responsibilities

Research Operations

  • Collaborate with principal investigators and clinical research teams in conduct of treatment and natural history studies
  • Ensure efficient start up and implementation of studies
  • Assure safe conduct of studies and appropriate collection of biologic samples following principals of Good Clinical Practice
  • Coordinate research operations with Data Operations Manager, the Laboratory Director, Project Managers, and Regulatory Affairs staff
  • Plan and participate in research meetings and monitor activities across protocols Coordinate with Project Managers and Regulatory Affairs to assure that regulatory submissions are initiated, completed, organized, and submitted in a timely manner
  • Identify operational, logistical, and regulatory challenges related to the conduct of clinical trials and work flow within the research group and act as the leader in their resolution
  • Supervise internal and external monitoring visits and audits
  • Oversee standard operating procedures across clinical trials
  • Prepare progress reports on protocol implementation and site productivity for Global Oncology leadership

 

Research Administration

  • Communicate regularly with finance and grants and contracts staff to prepare budgets for and manage staffing for new clinical research studies
  • Communicate and collaborate with HCRI-Uganda Site Administrator to plan for and support administrative and operations support for all clinical research studies
  • Coordinate with HCRI-Uganda HR to hire and manage clinical research staff

 

Supervision

  • Ensure sufficient recruitment for clinical studies and supervise training of Uganda-based research staff
  • Supervise project managers and research nurses and study medical officers
  • Create clear plans for staffing of studies, ensure cross-coverage and responsiveness in a dynamic environment

 

Training

  • Mentor nursing research staff and oncology nurse trainees
  • Provide education on oncology drug administration
  • Serve as a resource for nurse initiated scholarly activities such as quality improvement projects and education projects

Qualifications

Required qualifications:

  • Master’s degree in nursing or other relevant field, advanced degree desirable
  • 5+ years clinical trials or clinical research experience
  • 3+ years supervisory experience
  • Demonstrated expertise in principals of Good Clinical Practice
  • Familiarity with clinical trial reporting requirements
  • Interest in global health
  • Experience mentoring nurse trainees
  • High level of attention to detail, organizational skills and commitment to accuracy
  • Strong oral and written communication skills
  • Strong problem-solving skills and ability to prioritize competing tasks
  • Ability to effectively direct study teams and research site personnel
  • International experience, especially in low-income settings strongly preferred

 

Desired Qualification

  • Oncology nursing experience strongly desired
  • Familiarity with HIV/AIDS and other infectious diseases desirable
  • Experience with Electronic Data Capture systems for clinic trials
  • Training and supervisory experience
  • Flexibility with ever-shifting priorities, work schedule and the technological challenges faced in low-resource settings
  • Experience working with a team in which members are off-site
  • Comfort in an "iterative environment" in which periodic rework is inevitable.
  • Ability to problem solve and work independently as well as provide guidance and oversight to subordinates.
  • International work and living experience, particularly in East Africa, strongly preferred
  • Sense of humor

 

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.