Clinical Research Associate 3

University of Miami•Miami, FL

6d•Onsite

About The Position

The University of Miami/UHealth Department of Psychiatry has an exciting opportunity for a full time Clinical Research Associate 3 to work in Miami, FL. This role coordinates the implementation of multiple complex clinical research protocols, develops SOPs and templates, and oversees eligibility screening and study recruitment activities. The position also manages sample processing, packing, and shipping, and plans strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Additionally, it involves developing and implementing preventive/corrective actions, disseminating study-related best practices, and providing leadership in protocol implementation and study progress. The role also involves identifying and working through ethical conflicts, organizing site visits and auditing activities, coordinating research team meetings, and assuring synchronization of study visits with data collection schedules. The Clinical Research Associate 3 compiles information for research reports and publications, disseminates information to clinical personnel and stakeholders, and follows all applicable regulatory requirements. This position also requires maintaining requisite skills and mandatory training, and adhering to University policies and procedures. Department-specific functions include overseeing new referrals and ongoing clinical practice for the specialty UM Tics, OCD and Related Problems Program and the UM Tourette Association of America (TAA) Center of Excellence Program, including telephone screens, correspondence, intake packets, scheduling, and following up with clinical procedures. The role oversees clinical operations for the Chair’s clinical practice and referrals to the TAA Center of Excellence (CoE) Research program, supervises day-to-day operations of the Chair’s clinic, and coordinates CoE activities including liaison with the national TAA office and the South Florida chapter. It also involves setting up and implementing TAA CoE Tic Talks quarterly and participating in phone and video conference meetings in regional and national activities. The position coordinates and provides support for Chair academic activities, including literature searches, PowerPoint preparations, and manuscript drafts, edits, and submission. 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.

Requirements

Bachelor’s degree in relevant field required
Minimum 4 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.

Responsibilities

Coordinates the implementation of multiple complex clinical research protocols.
Develops SOPs and templates with guidance from the PI/Clinical Research Manager.
Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.
Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.
Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations.
Develops and implements preventive/corrective actions.
Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.
Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.
Organizes/manages site visits and internal/external auditing activities as assigned.
Coordinates research team meetings; assures communications across-the-board.
Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.
Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.
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.
Oversees all new referrals to and ongoing clinical practice for the specialty UM Tics, OCD and Related Problems Program and the UM Tourette Association of America (TAA) Center of Excellence Program.
Includes telephone screens of incoming new referral, correspondence, sending intake packets for initial evaluations, scheduling patients in UChart and following up with clinical procedures.
Oversees clinical operations for the Chair’s clinical practice and referrals to the TAA Center of Excellence (CoE) Research program.
Supervises day to day operations of the Chair’s clinic.
Coordinates CoE activities including liaison with the national TAA office, and the South Florida chapter.
Sets up and implements TAA CoE Tic Talks quarterly to disseminate clinical and research updates to the local and regional community.
Participates in phone and video conference meetings in regional and national activities.
Coordinates and provides support for Chair academic activities including, but not limited to, literature searches, Powerpoint preparations, and manuscript drafts, edits and submission.