Project Manager - Clinical Trials Office (Remote)

About City Of Hope

City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago, and Phoenix. City of Hope’s affiliated family of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram, and LinkedIn.

City of Hope’s commitment to Diversity, Equity, and Inclusion

We believe diversity, equity, and inclusion are key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity, and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds, and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds, and perspectives; this is reflected in our work and represented in our people.

Position Summary

Under the direction of the Senior Director, Clinical Trial Office Operations and the CTO leadership team with input from the Disease/Modality (D/M) Team Chairs and the Study Investigators, the Project Manager (PM), as a senior regulatory team member and leader, assists investigators with the submission and activation of their human subject research to the various regulatory committees who review and approve research including scientific review and IRB review. The CTO regulatory team facilitates a prompt submission of new protocols, study updates, amendments and other regulatory related materials to regulatory oversight committees by preparing committee applications and collecting documents for review. The PM serves as the primary point of contact for faculty, staff and sponsors for trial submission, approval and activation at COH.

Key responsibilities include:

• PMs are responsible for working with investigators and Clinical Trials Support Services (CTSS) for budget development, Medicare coverage analysis (MCA) and OnCore calendar builds to ensure timeliness and accuracy.
• Management of the initial study submission, ensuring proper D/M Team endorsement and serves as the liaison to sponsor and submits research to external IRBs such as WIRB and/or NCI CIRB The PM oversees the ongoing regulatory management of studies for their assigned D/M Team for other submission types (e.g., deviations, continuing reviews, adverse events). COH uses Integrated Research Information System (iRIS) as its electronic protocol submission system and OnCore as the Clinical Trials Management System (CTMS).
• PM will exhibit expertise in the regulatory and operations arena of clinical trials.
• Holds a significant role in supporting a timely study start process and is responsible for collecting and providing sponsors with regulatory documents as well as serving as a lead and mentor to regulatory coordinators. This includes assisting leadership with onboarding, training, and implementation of new processes or changes.
• Will frequently interact with Principal Investigators (PIs) and their research staff including but not limited to clinical research coordinators, research nurses, monitors, data coordinators, as well as the various committee administrative staff.

Basic education, experience, and skills required for consideration:

• Observes sensitivity to the maintenance of confidentiality.
• Will foster/promote a positive image and professional appearance.
• Excellent skills in time management, prioritization, and multi-tasking required.
• Exhibits sensitivity to intercultural relations.
• Demonstrate strong organizational skills and ability to practice independently.
• Must have the minimum of a Bachelor's Degree.
• Ability to focus on task is essential.
• Minimum of 2 years of experience related to the regulatory management and conduct of oncology clinical trials in an academic setting.
• Must have strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with co-workers and customers.
• Must have working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.

Additional Information:

• The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
• As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

City of Hope is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with a disability.

Basic education, experience, and skills required for consideration:

• Will foster/promote a positive image and professional appearance.
• Demonstrate strong organizational skills and ability to practice independently.
• Must have working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
• Excellent skills in time management, prioritization, and multi-tasking required.
• Observes sensitivity to the maintenance of confidentiality.
• Ability to focus on task is essential.
• Must have strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with co-workers and customers.
• Must have the minimum of a Bachelor's Degree.
• Minimum of 2 years of experience related to the regulatory management and conduct of oncology clinical trials in an academic setting.
• Exhibits sensitivity to intercultural relations.

Additional Information:

• The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
• As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

City of Hope is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with a disability.