Clinical Research Coordinator 2 (A)

Core Job Functions

• 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.
• Collections, 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.
• Affords assistance in implementing protocol amendments under direct supervision of the Principal Investigator.
• Affords assistance with study orientation and protocol related in-services to research team and clinical staff.
• Maintains protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
• Affords assistance 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.

Qualifications

• Bachelor’s degree in relevant field
• Minimum 2 years of relevant experience

Department Addendum

• Reviews and administers informed consent forms to study participants.
• Schedules patients for research-related visits and contacts patients for clinical follow-up requirements.
• Coordinates activities between departments to accomplish study goals.
• Affords assistance in study related tasks, follow-up visits, procedures, and assessments as required per protocol.
• Maintains updated records of long-term follow-up participants, collect and required data on a timely bases, respond to sponsor queries.
• Retains records of payments to study participants.
• Completes patients’ data forms and reviews medical charts for patients’ vital signs and other medical data to complete case report forms.
• Maintains records of study results and study participants.
• Keeps an active pool of study candidates to ensure availability.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

Pay

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

Schedule

The position is full-time.

Benefits

The University of Miami offers a comprehensive benefits package including medical, dental, vision, life insurance, disability, retirement plans, and paid time off.

Skills

N/A

Benefits

N/A

Pay

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

Schedule

The position is full-time.

Benefits

The University of Miami offers a comprehensive benefits package including medical, dental, vision, life insurance, disability, retirement plans, and paid time off.