Senior Clinical Research Specialist

• 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
• 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
• Oversees and facilitates eligibility screening and study recruitment activities
• 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

• Bachelor's degree and 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
• Published peer-reviewed papers as leading author or co-author
• 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

Master’s degree preferred