The Clinical Research Project Manager (CRPM) will lead clinical trials within the OHSU Skin Cancer Research Group (directed by Dr. Yu).

 

The OHSU Skin Cancer Research Group conducts translational research to optimize treatment for patients living with skin cancer. As a leader within this group, the CRM will have the opportunity to grow a dynamic clinical trials portfolio including both investigator initiated and industry sponsored trials. The CRPM will work with Dr. Yu and other leaders within the OHSU Melanoma program to attract and activate additional industry sponsored trials, execute strategic patient recruitment plans, and build a collaborative interdisciplinary trials team. This position oversees clinical trial research activities of research personnel in a manner that effectively maximizes quality and compliance with clinical research standards, participant safety, and staff satisfaction.

 

The CRPM will also be an essential member of the Melanoma Tumor Board and clinical care team. Consistent with NCCN guidelines and the Knight Cancer Institute mission, the CRPM will establish and implement standard procedures to evaluate all patients for clinical trial participation. The CRPM will assist in offering these treatment options to patients who qualify in order to provide the highest standard of cancer care.

• Independently manages a large research program or multiple moderate to large programs. Designs and develops major program components, develops research, evaluates protocols and feasibility, develops budgets, and establishes effective team dynamics. Develops ideas and options for review and decision and develops and implements research programs that reflect stakeholder interests. Evaluates effectiveness of program in meeting goals. Plans, directs and controls program budget. Supervises program staff.
• May teach seminars and workshops and participate with faculty on research. Serve as a content expert to research staff. May provide supervision to staff.
• Provides recommendations and process/tools development to ensure deliverables are done on time and within budget.
• Conducts comprehensive medical record review of patients as part of clinical trial recruitment and screening, determining compliance, and coordinating patient care services.
• Manages regulatory aspects of clinical trials including preparing for audits and inspections, development of corrective action plans, and follow up.

• Master's in relevant field AND 3 year of relevant experience OR equivalent combination of Bachelor's in relevant field in conjunction with training and experience may be considered.
• At least 3 years experience in clinical trials coordination, management, and regulatory compliance.
• Knowledge of and experience in outpatient and/or inpatient clinical environment, clinical trial regulatory and data submission requirements.
• Ability to analyze research protocols and OHSU/Knight Cancer Institute policies and procedures with respect to implementation and medical, fiscal, compliance, quality, and risk management aspects. In-depth working knowledge of GCP, federal, state, and local regulations including HIPAA policies and procedures.
• Effective written oral and written communications skills.
• Experience with RedCap and other clinical trials data management programs.
• Willingness to obtain other certifications if required.

• Clinical Trials Professional certifications (eg. ACRP-CP, CCRA, CCRC, and others).

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.