University of Rochester Advancement · 1 month ago
Senior Clinical Research Specialist
Strong Memorial Hospital
Full-time
Onsite
Mid, Senior Level
$60K/yr - $85K/yr
3+ years expThe University of Rochester is committed to fostering an inclusive and welcoming culture. The Senior Clinical Research Specialist will provide leadership in planning and managing multiple clinical research protocols, ensuring participant safety, adherence to study protocols, and mentoring less experienced staff.
Higher Education
Responsibilities
Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols
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
With minimal supervision, 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 and 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 timeline
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, and 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 SOPs
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
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 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
Qualification
Required
Bachelor's degree and 3 years of relevant experience required
Or equivalent combination of education and experience
Ability to effectively manage complex research protocols/procedures required
Fully adheres to applicable safety and/or infection control standards required
CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1 year required
SOCRA - Certification In Clinical Research within 1 year required
Preferred
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
Company
University of Rochester Advancement
The University of Rochester, one of the nation’s top private research universities, has built a national caliber advancement program in support of the largest campaign in the University’s history.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase