Project Manager

City of Hope; Irvine (CA); Remote; USD 4,000 - 7,000; Full time

Job summary

Join a leading health organization and apply for the Project Manager role, focusing on the regulatory aspects of oncology clinical trials. Bring your expertise to facilitate research submissions and manage compliance while working in a collaborative environment committed to transforming patient care.

Qualifications

• Minimum of 2 years of experience in oncology clinical trials.
• Working knowledge of clinical trials, Federal, State, and Local Regulations.
• Certification in Clinical Research (SOCRA or ACRP) preferred.

Responsibilities

• Manage submission and activation of human subject research protocols.
• Liaise between investigators and regulatory bodies for trail approvals.
• Ensure timely study start processes and regulatory compliance.

Skills

Regulatory Management

Clinical Trials Knowledge

Oncology Expertise

Education

Bachelor’s degree

Job description

Join to apply for the Project Manager role at City of Hope

Join to apply for the Project Manager role at City of Hope

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This range is provided by City of Hope. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$43.00/hr - $66.00/hr

Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. 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. our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.

Project Manager-Remote

Must have Minimum of 2 years of experience related to the regulatory management and conduct of oncology clinical trials in an academic setting. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent forms, and protocol development.

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.

The PM is responsible for managing 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 are also 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.

The PM plays a significant role in supporting a timely study start process and is responsible for collecting and provide sponsors with regulatory documents as well as serve as a lead and mentor to regulatory coordinators. This includes assisting leadership with onboarding, training, and implementation of new processes or changes. All regulatory coordinators must have a working knowledge of institutional, federal and state policies. The PM must have expertise in the regulatory and operations arena of clinical trials. The position requires frequent interaction 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.

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned.

Your qualifications should include:

Position Qualifications:

Minimum Education: Bachelor’s degree.

Minimum Experience: Minimum of 2 years of experience related to the regulatory management and conduct of oncology clinical trials in an academic setting. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent forms, and protocol development.

Pref. Certification/Licensure: Certification in Clinical Research, SOCRA or ACRP Certification.

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

City of Hope is an equal opportunity employer.

To learn more about our Comprehensive Benefits, please CLICK HERE.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management and Information Technology

• Industries

  Hospitals and Health Care, Non-profit Organizations, and Research Services

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