Job Information
Actalent Clinical Research Coordinator in Rochester, New York
Description:
Oversees and coordinates human subject research activities for multiple clinical trials, with an emphasis on those that are focused on Airway Inflammation and Lung Function in Asthma
Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies
Receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials to immediate team members and relevant others
Develops, implements and evaluates recruitment strategies, information and data systems and study management systems for assigned studies
Facilitates eligibility screening and study recruitment activities, including study timelines and schedules appointments and study visits
Conducts visits to ensure research participant adherence with protocol requirements.
Data Collection, Management and Maintenance
Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents
Performs data collection and uses required data systems for tracking study progression, monitoring and reporting on deliverables, quality and safety tracking, according to protocol requirements and established operational procedures and timelines
Maintains relevant study logs, through sponsors related, and related systems, including OnCore, according to UR and department Standard Operating Procedures (SOPs).
Regulatory, Quality and Compliance
Participate with the IRB to address any issues with the on-going studies, prepare and submit annual reviews, prepare and submit study amendments.
Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data.
Reviews study progress, including data, finances, documentation and reporting deliverables.
Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.
Initiates, monitors and ensures that all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified
Communication
Represents sites, providers, study team, patients, study participants and the regard to the coordination of human subjects studies
Prepares for, participates in and serves as a liaison for sponsor monitoring visits. Develops good working relationship with sponsors to foster a positive research environment and attend study Investigator/Coordinator meetings as required
Develops, monitors and maintain working relationships, positive communications among the Principal Investigator, research staff, study sites, sponsor and regulatory agencies, with regard to the coordination of human subject studies.
Training
Trains on study specific protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols
Directs the activities of subordinate staff to gather, compile and analyze study information
Professional Development
Demonstrates accountability for continuous learning in accordance with Good Clinical Practice (GCP) 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, such as ClickIRB and OnCore, needed to manage clinical research.
Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards
Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines
Participates in protocol-related training as required
Qualifications:
Bachelor’s degree required.
3 years of experience in human subject research coordination required
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.