Sr. Clinical Research Specialist

University of Rochester•City of Rochester, NY

11d•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. Responsibilities: Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Manages the day-to-day operations of multiple studies, carrying out study coordination duties from protocol development and initiation through to study close-out in accordance with regulatory/sponsor guidelines, ensuring the integrity of each study, and mentoring 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 the safety and adherence of study participants to the study protocol. Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities and personnel. ESSENTIAL FUNCTIONS 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 accruals and may perform second eligibility checks as delegated by leadership. Addresses e-mail and phone inquiries, participates in discussions with candidates in the 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 according to protocol, advocating for study participants and upholding quality standards throughout the study's lifespan. Provides leadership in resolving logistical challenges to ensure study objectives are achieved according to protocol and the 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 and 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 risks and 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. Lead the conduct of systematic reviews; support the preparation and submission of grant applications; and assist with Research Ethics Board (REB) applications, amendments, and continuing reviews, ensuring compliance with institutional and regulatory requirements. 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 the use of UR-specific research software needed for their clinical 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, 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 the same way. Participates in protocol-related training as required. Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department SOPs. 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. Other duties as assigned

Requirements

Bachelor's degree and 3 years of relevant experience required Or equivalent combination of education and experience
3 years of relevant experience required
Ability to effectively manage complex research protocols/procedures required
Fully adheres to applicable safety and/or infection control standards
Proficiency in medical terminology, the clinical research process, and applicable regulatory guidelines, standards preferred
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, and 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, and internet
Possesses a high degree of self-motivation
Recognized ability to function independently
Experience in preparing REB documents, supporting grant applications, and managing budgets
CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1 year or SOCRA - Certification In Clinical Research within 1 year required

Nice To Haves

Master’s degree preferred
Published peer-reviewed papers as leading author or co-author

Responsibilities

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols.
Manages the day-to-day operations of multiple studies, carrying out study coordination duties from protocol development and initiation through to study close-out in accordance with regulatory/sponsor guidelines, ensuring the integrity of each study, and mentoring 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 the safety and adherence of study participants to the 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 accruals and may perform second eligibility checks as delegated by leadership.
Addresses e-mail and phone inquiries, participates in discussions with candidates in the 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 according to protocol, advocating for study participants and upholding quality standards throughout the study's lifespan.
Provides leadership in resolving logistical challenges to ensure study objectives are achieved according to protocol and the 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 and 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 risks and 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.
Lead the conduct of systematic reviews; support the preparation and submission of grant applications; and assist with Research Ethics Board (REB) applications, amendments, and continuing reviews, ensuring compliance with institutional and regulatory requirements.
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 the use of UR-specific research software needed for their clinical 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, 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 the same way.
Participates in protocol-related training as required.
Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department SOPs.
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.
Other duties as assigned