Sr Health Project Coord

GENERAL PURPOSE:

We are looking for a Research Project Manager (Senior Health Project Coordinator) who is self-motivated, committed to excellence, humble, hardworking, as well as a team player to join Dr. Loh’s team to help improve lives of older adults with blood cancer through researching behavioral and supportive care interventions. The program manager should have an effective interpersonal communication, group facilitation/cultural competency, and professional writing skills who can manage competing priorities and function independently. Dr. Loh is a geriatric hematologist with a MS in Clinical Investigation and a strong publication record. As Program Manager, you will oversee a clinical research team consisting of 5-10 members including staff and trainees (undergraduate, post-graduate, and medical students) who will directly report to the Program Manager. Program Manager will take primary responsibility with onboarding activities for trainees (undergraduate, post-graduate, and medical students). In partnership with Dr. Loh, Program Manager will oversee and ensure successful delivery and execution of clinical trial operations, including personnel management and regulatory compliance. Program Manager will ensure that all institutional, local, state, and federal regulations, good clinical practice (GCPs), ICH, and IRB requirements are met. The positions primary responsibilities include but are not limited to development of strategies for patient recruitment and support of patient recruitment in a backup role, compliance, performance and quality improvement, operational efficiency, and employee engagement. When needed, project manager is expected to help with coordination and patient recruitment alongside other research staff. Travel may be necessary to the Wilmot catchment areas such as Highland Hospital, Comprehensive Breast Cancer Center at Pluta, Dansville, Batavia, Geneva, Canandaigua, Greece, Brockport, Hornell, Olean, Webster, and Wellsville.

The position will start in October/November 2023.

SPECIFIC RESPONSIBILITIES:

Oversight of assigned Geriatric Oncology staff :

Provide oversight for 5-10 study members including the following tasks:

• Onboarding, training (including undergraduate, post-graduate, and medical students.), documentation of core competencies, certification mandates, safety/responsible conduct of research education and performance evaluations,

• Generates monthly reports including but not limited to performance, accrual, monitoring, time to activation, audit visits, and financial performance.

• Manages the day-to-day operations, issue resolution, and supervision of assigned staff.

• Coordinates multi-center recruitment efforts, and trains investigators and study coordinators for participating centers. Supervises on-site monitoring of participating centers.

• Completes annual performance evaluation process; ensures fair and accurate evaluation following standards of performance. Provides counseling and constructive feedback for employee development.

• Addresses disciplinary issues.

• Participates in team building and training activities.

Participate in actions as to hiring, transfers, promotions, and terminations of study members. Performs QA and supervision of team project timelines, adherence to procedures, and all other activities. Participates in staff recruitment and retention initiatives.

Ensure the accuracy of clinical trial information in all CTMS, clinical trial and research databases, and tracking systems. Ensure quality, timely, and accurate data and report submission. Oversees processes to ensure the scientific integrity of data with coordinator staff.

Project Management:

• Ensures all research team members understand the scope of each project and individual responsibilities.

• Allocates and assigns personnel and technical resources.

• Provides professional direction, oversight, and plans for internal meetings project management team.

• Oversees the planning and implementation of the PI/Coordinators’ meeting.

• Plans the study timeline and regularly monitors adherence, metrics, and progress throughout the study lifecycle.

• Regularly presents a status overview to Geriatric Oncology leadership

• Works with assigned Regulatory Managers and regulatory team to ensure and track regulatory compliance for studies.

• Tracks and documents research milestones and activities

• Communicates frequently with external and internal institutions to assure compliance with research activities and provides direction for those institutions in regard to research compliance, training, recruitment, and reporting.

• Oversees efficient conduct of the assigned projects from study start-up, protocol amendments, to closure and data analysis.

• Assists in the development and creation of project-specific documents used at multiple institutions such as protocols, consent forms, source materials, recruitment materials, and database forms, and cross-project documents such as policies and procedures.

• Assists with components of grant submissions and grant progress reports. (e.g. data archives; data sharing; clinicaltrial.gov

• Assists with components of abstracts/manuscripts (e.g., submission, formatting, etc.)

• Assists with the coordination of all phases as it relates to the study start-up, data reporting, and close-out of research projects.

Complies with Good Clinical Practice and the Code of Federal Regulations

• Oversees and participates in the development, implementation, and routine updating of Standard Operating Procedures (SOPs) to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the integrity of clinical trials and research activities.

• Provide professional direction for projects

• Prepare for internal and external audits

• Requires a thorough understanding of proposed and active protocols

Financial Responsibility and Oversight in conjunction with grant administration personnel:

• Provide guidance on Geriatric Oncology financial activity inclusive of the annual operations budget, study-specific clinical trial budgets, and associated cost recovery, or post-award activities.

• Oversees purchases of software, equipment, questionnaires, etc. for the study team

URCC NCORP Research Base and other Stakeholder groups

• Serve as liaison to advance clinical trial and research interests including participation in community outreach; liaison to other University departments and collaborators, NIH, NCI, and external PIs, co-PIs, investigators, pharmaceuticals, and other companies.

• Interacts professionally with local and national research structures including the NCI Community Oncology Research Program Research Base, the Clinical and Translational Science Institute, the Cancer and Aging Research Group, and funders including the NIH.

• Assists in supporting the relationship (secondary liaison) with patient and caregiver stakeholders’ group through meeting scheduling, email communication, and tracking fees

Data Management and Analysis:

Plans and implements a comprehensive data management and information system:

• Assist with both database design and implementation resulting in a successful study project deliverables and outcomes.

• Collaborates with other database designers to accomplish successful outcomes and move forward with design and implementation activities.

• Oversee and collaborate on managing the research study databases.

• Employ best practices and robust techniques to minimize the risk of data loss or compromised access.

• Spends time testing new technologies and their feasibility to ensure accurate operations of the application.

• Develops consistent HIPAA secure procedures for data collection, entry, and analysis and established a quality control mechanism.

• Coordinates multiple research-related team-based activities including but not limited to compliance with NIH policies (e.g. data archives; data sharing; clinicaltrial.gov), oversight of data protection, oversight of data management and analyses procedures, and oversight of abstracts and publications.

Diversity, Equity, and Inclusion:

• Promotes and improves upon diversity, equity, and inclusion by ensuring a culture of inclusivity and respect, and by promoting activities between Geriatric Oncology Research Group and others at Wilmot Cancer Institute, URMC, and UR.

• Participate and contribute to the DEI committee within the Geriatric Oncology Research Group.

Professional Development

• Keeps up to date on the latest research, regulations, and guidance.

• Maintain working knowledge of the specialty as well as the current regulations, industry standards, and good clinical practices for conducting individual protocols.

• Attend meetings and pertinent seminars in academic settings.

Other project duties as assigned

REQUIREMENTS:

• Bachelor's degree with major course work in an appropriate health, social or technical field, Master’s degree preferred with focus on Health Education, Clinical Research Investigation, Health Services, Public Health, or another related Field required.

• 3-5 years of related experience; or an equivalent combination of education and experience. 5-6 years of clinical trial experience is preferred with evidence of progressive leadership experience required.

• The candidate should have extensive knowledge in clinical research operations and associated regulations governing clinical research. Strong communication skills (verbal and written). Strong interest in older adults with cancer. Ability to provide leadership and promote collaboration. Candidate must possess exceptional organizational and time management skills. Some experience in qualitative and quantitative methods as well as grant writing are desired preferred.

• Good Clinical Practice, Human Subjects Protection

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $ 57,595 - $ 80,600 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 055 Geri Onc M&D
Schedule: 8 AM-4:30 PM