Clinical Research Coordinator 2

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The University of Miami/UHealth Department of Psychiatry has an exciting opportunity for a full time Clinical Research Coordinator 2 to work in Miami, FL.

The Clinical Research Coordinator 2 (CRC 2) will report to the Department Chair and serve as the Clinical Coordinator for the Tics, OCD and Related Disorders Program at the UHealth Tourette Association of America (TAA) Center of Excellence.

The incumbent will conduct thorough phone calls with patients and properly triage patients, maintain a calendar on behalf of the Chair, and provide routine and general clerical support or medical-related support which may be related to both patient care and research. Additionally, the incumbent will observe and receive direct training and supervision to assist with patients.

The CRC 2 will assist in collecting histories of new patients and performing assessments under the supervision of the Chair and other team specialists. The CRC2 will assist in referral of eligible clinic patients to appropriate research related studies and activities.

S/he will organize and arrange community activities to advance the goals and aims of the Tourette Association of America (TAA) Center of Excellence including a speaker series and trainings. Additionally, the incumbent will assist the Department Chair with document preparation for new grant submissions as well as related tasks such as performing literature reviews, article submissions to various academic journals, chart reviews, data analysis, and Power-point and poster presentations.

In addition, the incumbent will handle the process of conducting research studies and related projects, including coordination of activities of research projects both interventional and observational, study participant related activities such as recruitment, screening, assessments, follow-up assessments, data collection and management using electronic data capture systems, interaction with patient's treatment team, and preparation of participant reimbursements.

The CRC 2 will ensure that the study is conducted according to protocol design and will report deviations as they arise, and maintain study files such as regulatory documents, correspondence, case report forms and data files - in compliance with all regulatory requirements and in accordance with Good Clinical Practice.

S/he will perform activities related to regulatory compliance such as IRB submissions, mandates issued by the study sponsor, and any other regulatory entity.

Additionally, the CRC2 will work closely with the Chair's Executive Assistant on coverage of Department clinical administrative matters.

Core responsibilities

• 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.

Additional information

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.

Core 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.
• 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.

Pay and benefits

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.

Job Status: Full time

Employee Type: Staff