Clinical Research Coordinator 2

Benefits

Qualifications

• •Bachelor’s degree in relevant field required
• •Minimum 2 years of relevant experience required
• •Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands
• •Teamwork: Ability to work collaboratively with others and contribute to a team environment
• •Technical Proficiency: Skilled in using office software, technology, and relevant computer applications
• •Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders
• •3 more items(s)

Responsibilities

• •The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies
• •This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines
• •The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel
• •Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility
• •Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols
• •Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations
• •Maintains study binders and filings according to protocol requirements, UM and department policy
• •Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator
• •Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations
• •Assists in implementing protocol amendments under direct supervision of the Principal Investigator
• •Assists with study orientation and protocol related in-services to research team and clinical staff
• •Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule
• •Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments
• •Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews
• •Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc
• •Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies
• •Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies
• •Adheres to University and unit-level policies and procedures and safeguards University assets
• •This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary
• •16 more items(s)