Lead Clinical Research Spec

Benefits

Qualifications

• •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
• •Proficient in MS Office (e.g
• •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
• •4 more items(s)

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
• •46 more items(s)