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The University of Miami/UHealth Department of OBGYN has an exciting opportunity for a full-time Clinical Research Coordinator II (A) to work in Miami, FL.The Clinical Research Coordinator II (A) 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.

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.

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.

Department Specific Functions

The Department of OBGYN & Reproductive Sciences has an exciting opportunity for CRCII to have a lasting impact on women’s health. As an important team member, the CRCII is embedded in Labor & Delivery of OBGYN of JMH. The CRCII is charged with implementing clinical research alongside clinical staff.

A successful candidate has experience conducting patient facing research activity. Experience screening and enrolling study participants into clinical research studies.

Engage and educate OBGYN patients, clinical teams and community about ongoing opportunities to participate in clinical research.

Screen schedules for eligible subjects’ form visits and ultrasound schedules

Approach and consent eligible women for enrollment.

Execute proper process of informed consents. (Copies, filing etc.)

Follow the steps outlined in sponsor protocol. Including scheduling and completing follow-up visits a necessary.

Ensure blood collection as per Sponsor SOPs.

Ensure proper sample processing and shipping as per Sponsor SOPs.

Ensure timely data entry into velos and other data capture systems as needed.

Attend weekly clinical research team meetings.

CORE QUALIFICATIONS                                                                                                         

Bachelor’s degree in relevant field

Minimum 2 years of relevant experience

Skill in completing assignments accurately and with attention to detail.

Ability to analyze, organize and prioritize work under pressure while meeting deadlines.

Ability to process and handle confidential information with discretion.

Ability to work evenings, nights, and weekends as necessary.

Commitment to the University’s core values.

Ability to work independently and/or in a collaborative environment.

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

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

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