Manager, Clinical Research

Opening

Full Time 40 hours Range URG 112 Medicine M&D-Infect Dis Unit

Schedule

8 AM-4:30 PM

Responsibilities

GENERAL PURPOSE:

The Department of Medicine, Infectious Disease Division,(IDD) at The University of Rochester is seeking a full-time Clinical Research Manager to oversee and manage clinical research. Within IDD, the HIV/AIDS Clinical Trial Unit (CTU) conducts a robust research portfolio that encompasses prevention and treatment HIV and COVID research, as well as antibiotic resistance and flu research. This is a funded grant through the Division of Allergy and Immunology Division of the National Institute of Health.

This Clinical Research Manager is responsible for the day-to-day oversight and management of Clinical Research Projects and Staff within the CTU in IDD. They will manage the daily operations, including technical/administrative, financial, quality, and personnel management and monitors research activity to ensure compliance with Standard Operating Procedures and Good Clinical Practices within the HIV Vaccine Trials Network Clinical Research Stie (HVTN CRS).

RESPONSIBILITIES:

Oversight of assigned study personnel including orientation, training, documentation of core competencies, certification mandates, safety/responsible conduct of research education and performance evaluations, including the following tasks:

• Manages the day-to-day communication and shared activities for human subject research studies involving units within and external to the University, issue resolution, and supervision of assigned staff

• Assigns staff to protocols and manages workload

• Oversees and facilitates eligibility and screening and study recruitment activities

• Performs QA and supervision of team OnCore entries, research tabs and reports.

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

• Participates in staff recruitment, including review of applications, interviews and hiring, as well as promotion and retention initiatives activities,

Study Start-Up and Ongoing Financial Oversight:

• Provides professional direction for the projects. Creates, plans, develops, implements, and manages study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas.

• Organizes and plans project start-up including working with the sponsor and internal resources (CRC, IDS Pharmacy)on budget and agreement, applying for IRB other ancillary approvals.

• Reviews potential projects for feasibility, in terms of staffing needs, recruitment, financial break-even analysis and scientific overlap with existing studies

• Designs source documents and databases. Prepares documents for study sponsor and regulatory agencies including WIRB, RSRB, NIH, and FDA..

• Writes informed consent forms.

• Analyzes and confirms all relevant effort allocation of clinical research staff

• Tracks and documents research milestones and activities conducted in line with the project goals and manages invoicing and payments.

Manages the clinical trial studies and portfolio within the HIV/AIDS CTU, including the following tasks:

• Operational assessment of proposed new research protocols

• Effectively communicates with the research team, sponsor, data coordinating center, compliance monitors, collaborators, investigators' academic administrative personnel, and other departments

• Provides as a point of contact for HIV/AIDS CTU physicians

• Providers coverage and backup for HIV/AIDS CTU team research coordinators as needed

• Provides leadership in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected time-lines

• Assumes leadership in protocol implementation and study progress, keeping investigators appraised of study progress

• Performs safety and quality improvement efforts, minimizing risk/safety threats

• Prepares for and responds to internal and external audit

• Plans and operationalizes strategies to monitor, document, report and follow up on unanticipated occurrences, protocol deviations; develops and implements preventive/corrective actions

Professional Development:

• Obtains and/or maintains clinical research certification.

• Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.

• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.

• Maintains CITI and Conflict of Interest (COI) certification and renewal as required.

• Maintains proficiency in UR-specific research software, including ClickIRB and OnCore, needed to manage clinical research protocols.

• Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in same.

• Participates in protocol-related training as required.

• Join HVTN Working Group.

Participates in department and network specific goals including (but not limited to the following):

• Identified and develops new CTU specific SOPs.

• Updates and revises current SOPs as needed.

• Participates in CTU team building and training activities

• Works in conjunction with leadership to improve operation and financial performance, utilizing OnCore and other university systems

Complies with Good Clinical Practice and the Code of Federal Regulations:

• Performs audits for compliance.

• Ensures proper study documentation is on file in the investigators' files for the Sponsor, IRB, FDA or other federal agencies.

• Oversees compliance with and effectiveness of Clinical Research procedures; recommends revisions as needed.

• Demonstrates initiative in improving operational and financial performance with effective decision-making, planning and implementation skills.

• Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures (SOPs), and guidelines.

• Keeps current with industry standards, best practices, and trends relevant to research studies.

• Participates, joins and eventually leads HVTN level committees.

• Attends all network full group meetings- HVTN (required), ACTG (as needed).

• Represents and key communicator with the CRS/CTU to the Division of AIDS Division Program Officer.

• Key contributor to the annual Research Performance Progress Report.

• Ongoing strategize as part of the leadership team to implement programs and initiatives to increase site status for next full grant submittal.

• Key contributor to the next full grant submittal- 2026.

QUALIFICATIONS:

Required:

• Bachelor's degree and 4 years of relevant experience
• 4 years clinical research or relevant work experience
• or equivalent combination of education and experience
• CCRP - Certified Clinical Research Professional within 1 year
• SOCRA - Certification in Clinical Research within 1 year

Preferred:

• Master's Degree in a health-related field

• Previous leadership experience

• Demonstrated leadership skills and competency

• Ability to effectively manage complex research protocols/procedures preferred

• Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standard

• Proficiency in managing multiple and competing priorities/demands

• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation

• Fully adheres to applicable safety and/or infection control standards

• Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork

• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients

• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet

• Possesses a high degree of self-motivation; recognized ability to function independently

• Experience with University Systems including ClickIRB, Advarra Participant Payments, OnCore, EPIC and eRecord

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.

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