Lead Clinical Research Spec

University of Rochester • Rochester, NY

19h • Onsite

About The Position

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

This position provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. It involves managing multiple studies' day-to-day operations, carrying out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, ensuring each study's integrity, and mentoring less experienced staff. The role also monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures, working closely with study team members and other study sites to ensure study participant safety and adherence to study protocol. Additionally, it manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.

Requirements

• Bachelor's degree and 4 years of relevant experience required Or equivalent combination of education and experience
• Fully adheres to applicable safety and/or infection control standards required
• Ability to effectively manage complex research protocols/procedures required
• Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines, standards preferred
• Proficiency in managing multiple and competing priorities/demands preferred
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred
• Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork preferred
• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred
• Possesses a high degree of self-motivation preferred
• Recognized ability to function independently preferred
• CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1 year required or SOCRA - Certification In Clinical Research within 1 year required

Nice To Haves

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

Responsibilities

• Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols.
• Provides mentorship and training to team members and provides coverage for clinical trials leadership as required.
• Manages multiple studies' day-to-day operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, ensures each study's integrity, and mentors less experienced staff.
• Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures.
• Works closely with study team members and other study sites to ensure study participant safety and adherence to study protocol.
• Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities, and personnel.
• Coordinates enrollment of participants.
• Coordinates the implementation of multiple complex clinical research protocols.
• Oversees and facilitates eligibility screening and study recruitment activities.
• Implements strategies to increase accrual and may perform second eligibility checks as delegated by leadership.
• Addresses e-mail and phone inquiries, participates in discussions with candidates in clinic, and consents for non-treatment trials.
• Plans study timelines and schedules appointments and study visits.
• Manages and organizes case report forms, source documents, and research records.
• Enters research data into data collection forms and/or study databases.
• Assists in conducting quality checks for data accuracy with data source records as assigned.
• Develops and implements strategies to promote adherence to cultural competency guidelines, meet participants’ needs for language translation, health literacy, etc.
• Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
• Manages and coordinates multiple complex studies and study patients.
• Maintains study continuity, coordinates study participants and research procedures.
• Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
• Provides leadership in resolving logistical challenges to ensure study objectives are achieved according to protocol and projected time-line.
• Performs data collection and data entry activities according to protocol requirements and established operational procedures and timelines.
• Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences, protocol deviations.
• Develops and implements preventive/corrective actions.
• Assists in identifying and developing data collection tools.
• Performs quality checks for data accuracy, reports/follows-up with discrepancies.
• Assists in safety and quality improvement efforts, minimizing risk/safety threats.
• Prepares for and responds to internal and external audits.
• Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators, academic administrative personnel, and other departments.
• Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department Standard Operating Procedures (SOPs).
• Assumes leadership assignments.
• Serves as back-up to the Clinical Research Manager (CRM) and assists or covers CRM duties and responsibilities as assigned.
• Takes a leadership role in special projects as assigned by leadership.
• Resolves complicated issues relating to research processes and core support.
• Assists in the education and training of such information with applicable staff.
• Assists in training less experienced research personnel in research competencies, UR and department SOPs, and protocol specific training.
• Assumes the trainer role for proficiency in use of UR-specific research software needed for their clinical research studies.
• Complies with Good Clinical Practice and the Code of Federal Regulations.
• Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
• Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
• 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 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.
• Other duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees