UPMC Research Manager in Pittsburgh, Pennsylvania
The UPMC Liver Cancer Center is led by experts at the forefront of comprehensive clinical services, innovative treatments, and fundamental research for primary and metastatic liver cancers. This role will lead the Liver Cancer Research efforts through the management of clinical trials, biobank studies, and clinical treatment protocols.
Assists the PI in reviewing new study requests, existing procedures/amendments related to complex research protocols and educates other staff of changes
Primary liaison for study monitoring and audit visits for complex and IITs (investigator-initiated trials), develops study implementation materials for complex studies and conducts in-service educations, mentors new hires and train in GCP and GDP methodologies, presents new studies at grand rounds/tumor board at community sites for provider education
Routinely monitors all trials for compliance with FDA, UPMC and IRB compliance; promptly and effectively reports any issues to leadership and assists with developing a plan of action.
Uses a variety of resources and strategies to manage the care of patients participating in research, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as management of symptoms.
Provides detailed and appropriate teaching to patients and families to effectively guide them through the research study
Design consistent process for post-treatment patient follow-up, in conjunction with the maintenance of physician/patient relationship.
Oversees all financial aspects of new and ongoing clinical trials, including budget creation and management of study billing
Reviews and coordinates the submission of all research related contracts
Provides leadership to the research team in ensuring collection of source data and completion of documentation that validated the integrity of research
Coordinate and oversee retrieval of prospective and retrospective data.
Orient, train and supervise all personnel in connection with outcome research data.
Provides general operational support for Liver Cancer Research
Work collaboratively with researchers holding them accountable for product, timeframes and management of their specific projects.
Analyze the training needs of project teams and identify relevant training material/ courses to address these needs.
Manage process and content within all program evaluation and clinical research, ensuring consistency with project goals, and appropriate allocation of resources.
Participate in and/or lead the comprehensive review of the research projects being managed by others and works with leadership to develop plans to provide the support needed for safe and successful conduct of research to our patients.
Consultant to all physicians, researchers, specific work groups, and organizations.
Manage and maintain overall quality assurance.
Identifies opportunity for quality improvement to colleagues and management
Fosters a mentoring environment.
Dynamically lead presentations/work sessions to positively influence decisions and perceptions.
Generate new perspectives, frameworks or innovations that enable research efforts and resolves problems with studies.
Ensure full compliance with all HIPAA regulations and IRB requirements, while maintaining the availability of patient-identifiable data.
Oversee and coordinate governmental audits such as the FDA and NCI.
Maintain integrity and security of all outcome research data.
Coordinate, process, and prepare outcome research data for relevant statistical analyses.
Develop and design procedures for processing outcome research data.
Develop and distribute outcome data research reports.
Develop and maintain central follow-up databases.
Develop and maintain outcomes and disparities clinical research database.
Bachelor's degree is required.
Master's degree can replace 2 years of experience. 3-5 years' research experience in health care or a related field.
Registered Nurse (RN) strongly preferred
Thorough knowledge and understanding of clinical research practices.
Management experience preferred, with experience in database design and programming relevant to multiple data source knowledge and experience interacting with governmental agency audits.
Ability to work independently.
Ability to manage multiple tasks efficiently and effectively.
Ability to adapt to multiple organizational structures.
Ability to meet deadlines and be flexible to sudden workload changes.
Effective interpersonal and communication skills.
Licensure, Certifications, and Clearances:
Registered Nurse (RN) strongly preferred
UPMC is an Equal Opportunity Employer/Disability/Veteran