Project Manager

Davita Inc.; Irvine (CA); Remote; USD 80,000 - 110,000; Full time

Job summary

Join a leading company where you will play a vital role as a Project Manager in oncology clinical trials, collaborating closely with investigators and regulatory teams. This remote position requires your expertise in regulatory management and a strong understanding of clinical trial processes. Together, we will work towards advancing critical cancer research and ensuring compliance with all necessary regulations.

Qualifications

• Minimum of 2 years in oncology clinical trial regulation.
• Experience with IRB requirements and protocol development.
• Certification in Clinical Research preferred.

Responsibilities

• Manage initial study submission and ongoing regulatory management.
• Serve as primary contact for trial submission and approval.
• Mentor regulatory coordinators and implement new processes.

Skills

Knowledge of clinical trials

Regulatory management

Collaboration with clinical teams

Education

Bachelor's degree

Job description

Join the transformative team atCity 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 Study Investigators, the Project Manager (PM) assists investigators with the submission and activation of human subject research to regulatory committees, including scientific review and IRB review. The CTO regulatory team facilitates prompt submission of new protocols, updates, amendments, and other regulatory materials by preparing applications and collecting documents. The PM serves as the primary contact for faculty, staff, and sponsors for trial submission, approval, and activation at COH.

The PM manages initial study submission, ensures proper D/M Team endorsement, and liaises with sponsors and external IRBs such as WIRB and NCI CIRB. The PM oversees ongoing regulatory management, including deviations, continuing reviews, and adverse events. COH uses iRIS and OnCore systems for protocol submission and trial management. The PM also collaborates with investigators and CTSS on budget development, Medicare coverage analysis, and calendar builds to ensure timeliness and accuracy.

The PM supports timely study start-up, collects regulatory documents for sponsors, and mentors regulatory coordinators. The role involves onboarding, training, and implementing new processes. All regulatory coordinators must understand institutional, federal, and state policies. The PM must have expertise in clinical trial regulatory and operational aspects and interact regularly with PIs, research staff, and committee personnel.

Follows City of Hope and departmental policies, procedures, objectives, and safety guidelines, maintaining confidentiality and integrity.

Performs other duties as assigned.

Qualifications

Your qualifications should include:

Position Qualifications:

Minimum Education: Bachelor's degree.

Minimum Experience: At least 2 years of experience in oncology clinical trial regulation and conduct in an academic setting, with knowledge of relevant regulations, IRB requirements, consent forms, and protocol development.

Preferred Certification/Licensure: Certification in Clinical Research, SOCRA or ACRP certification preferred.

City of Hope employees' pay is based on work experience, qualifications, and location.

City of Hope is an equal opportunity employer.

To learn more about our comprehensive benefits, please CLICK HERE.