Clinical Research Project Manager at Oregon Health & Science University in Portland, Oregon

Job Description:

Oregon Health & Science University

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.


Clinical Research Project Manager

US-OR-Portland

Job ID: 2024-32347
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Waterfront)

Overview

• 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.

Responsibilities

• 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.

Qualifications

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

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