Under direction of a Research Clinical Trial Operations leader, the Lead Clinical Research Coordinator CTO will independently coordinate and will be accountable for the overall administration and outcome of multiple clinical studies within the Clinical Trials Office, requiring advanced-level knowledge and skills, involving human subjects that are being conducted within the Nicklaus Children's Research Institute. Ensures processes are in place and roles are defined in order for studies to be conducted smoothly and compliantly, avoiding delays or errors with patient registration/enrollment and/or documentation and in accordance with protocol requirements. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities.
Provides guidance, training, and mentorship to Clinical Research Coordinators, Research Assistants and/or other support personnel.
Job Specific Duties
Serves as a subject-matter expert and resource for the research team on the compliant conduct of assigned studies.
Facilitates communication between investigators and Clinical Research Coordinators on subject-matter or technical matters.
Oversees study conduct including all support data collection for study start-up activities.
Oversees collection, maintenance, and reporting of accurate patient data for submissions to sponsors, maintaining patient records, and coordinating the collection and shipments of specimens as required by protocol.
Reviews and confirms subject study eligibility with PI/Sub-I of assigned studies.
Oversees study registration, patient screening/enrollment, and overall study requirements.
Registers and enrolls research participants.
Aggregates, tracks, trends, and reports research study and patient screening/enrollment data as required.
Interacts with patients and families to recruit (screen, consent, and enroll) study subjects and ensures compliance with the protocol.
Complies with the Research Finance Compliance policies and procedures including time and effort reporting for grants.
Submits protocol amendments and other documents requiring IRB submission to the Research Regulatory Affairs team and notifies CTMS support staff for protocol digitization.
Enters Research Patient information into CTMS within 72 hours of enrollment, patient visit, or patient-related event.
Pre-screens potential research participants and enters information into CTMS within real time (if possible) or within 24 hours.
Compiles accurate CTMS metrics data for updating SAC CTO slides and runs weekly enrollment reports for management review.
Updates study statuses in CTMS and ensures study enrollment changes are communicated to Research Regulatory Affairs team and CTO Management.
Attends meetings with Research management, research team, and/or PI/Sub-Is and is prepared to discuss research portfolio and/or patient status.
Qualifications
Minimum Job Requirements
Bachelor's Degree Bachelor's degree or higher and 5 years of research experience (OR) 9 years of research experience. (Required)
Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 16 months in position
Knowledge, Skills, and Abilities
Bachelor's degree in Nursing (BSN) and/or current RN licensure strongly preferred.
Ability to train, guide, and mentor peers.
Knowledge of rules and regulations governing the designated research.
Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems.
Bilingual in English/Spanish.
Excellent communication skills in working with both children and adults.
Software applications experience including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.
Experience with relevant hospital equipment for each clinical trial project.
Experience working on clinical trials, interventional studies all phases.
Advanced knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).
Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.
Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.
Ability to respond calmly under stressful conditions.
Ability to maintain confidentiality of sensitive information.
Ability to effectively work in a team.
Excellent time management and interpersonal skills.
Neighborhoods+Coconut Grove, Miami’s oldest neighborhood, is bohemian, green, and walkable under dense tree canopies, with waterfront parks, bike trails, art festivals, and boutique dining; median home $592,500, median rent $1,401, safer than 84% of Florida cities, 54.4% owner-occupied. Coral Way mixes historic charm and commerce ($404,100 median home, $1,616 rent, safer than 70% of Florida cities). Flagami ($287,165 home / $1,212 rent), Hialeah ($256,900 / $1,210), and West Little River ($169,100 / $1,174, the most affordable of the set) are budget suburban options. Coral Gables—“The City Beautiful”—is a planned Mediterranean community with homes around a $950,000 median (West Coral Gables, Coral Way, Ponce Davis). Young professionals working downtown often look near Dadeland or another metro station rather than paying Brickell prices; beach-oriented choices include South Beach, Surfside, Sunny Isles Beach, Bal Harbour, and Key Biscayne.
Coconut Grove, Miami’s oldest neighborhood, is bohemian, green, and walkable under dense tree canopies, with waterfront parks, bike trails, art festivals, and boutique dining; median home $592,500, median rent $1,401, safer than 84% of Florida cities, 54.4% owner-occupied. Coral Way mixes historic charm and commerce ($404,100 median home, $1,616 rent, safer than 70% of Florida cities).
Flagami ($287,165 home / $1,212 rent), Hialeah ($256,900 / $1,210), and West Little River ($169,100 / $1,174, the most affordable of the set) are budget suburban options. Coral Gables—“The City Beautiful”—is a planned Mediterranean community with homes around a $950,000 median (West Coral Gables, Coral Way, Ponce Davis).
Young professionals working downtown often look near Dadeland or another metro station rather than paying Brickell prices; beach-oriented choices include South Beach, Surfside, Sunny Isles Beach, Bal Harbour, and Key Biscayne.
Getting around+People working downtown are told to live near Dadeland or another metro station so the ride stays easy if they skip living in the core. Closeness to downtown or Brickell is what you pay for; a lifelong resident’s rule of thumb is an hour to 90-minute drive before housing gets cheap. Traffic is widely called nightmarish, South Florida rush hour is treated as a given, and parking in downtown areas is a premium add-on. Auto insurance is described among the highest in the nation, and rideshares jump in tourist season; sources do not name specific hospital campuses or bus/rail line numbers.
People working downtown are told to live near Dadeland or another metro station so the ride stays easy if they skip living in the core. Closeness to downtown or Brickell is what you pay for; a lifelong resident’s rule of thumb is an hour to 90-minute drive before housing gets cheap.
Traffic is widely called nightmarish, South Florida rush hour is treated as a given, and parking in downtown areas is a premium add-on. Auto insurance is described among the highest in the nation, and rideshares jump in tourist season; sources do not name specific hospital campuses or bus/rail line numbers.
Outdoors+Kayak, canoe, or stand-up paddle at Oleta River State Park, the Deering Estate, or Crandon Park. Boat through Biscayne National Park—95% underwater and part of the Florida Reef, the only living coral barrier reef in the United States. Hike or take guided tours in Everglades National Park and Big Cypress National Preserve; stroll Fairchild Tropical Botanic Garden among rare palms, aromatic fruits, and flowering trees. Coconut Grove adds waterfront parks, bike trails, The Barnacle Historic State Park, and Vizcaya Museum & Gardens; Zoo Miami lists over 500 species, and Maurice A. Ferré Park sits by the bay downtown. Snorkeling in a national park is treated as a same-day local outing.
Kayak, canoe, or stand-up paddle at Oleta River State Park, the Deering Estate, or Crandon Park. Boat through Biscayne National Park—95% underwater and part of the Florida Reef, the only living coral barrier reef in the United States.
Hike or take guided tours in Everglades National Park and Big Cypress National Preserve; stroll Fairchild Tropical Botanic Garden among rare palms, aromatic fruits, and flowering trees. Coconut Grove adds waterfront parks, bike trails, The Barnacle Historic State Park, and Vizcaya Museum & Gardens; Zoo Miami lists over 500 species, and Maurice A. Ferré Park sits by the bay downtown.
Snorkeling in a national park is treated as a same-day local outing.
Miami sells year-round tropical living and no state income tax: paddle-board in January, Cuban coffee and Michelin food the same week, Wynwood Walls or PAMM after a shift. Latin culture, Biscayne and Everglades wilderness, and Art Deco South Beach are the draw. Housing is the tax. Coconut Grove (median home $592,500, rent about $1,401) is the safest, greenest landing, with Barnacle Historic State Park; Coral Gables’ Mediterranean streets and top-rated schools run nearer $950,000. Flagami, Hialeah, and West Little River ($169k–$287k homes, rents ~$1,170–$1,210) stretch a nurse salary. Downtown workers often live by Dadeland or another Metrorail stop rather than Brickell rents. Tradeoffs: nightmarish traffic, tourist-priced leisure, June–September storms and hurricanes, wet-blanket summer humidity, and high flood and auto insurance. Off days, kayak Oleta River or Crandon Park, boat Biscayne’s reef, or skip the beach for Vizcaya and Fairchild Tropical Botanic Garden. Safer overall than Orlando or L.A.; still pick the neighborhood carefully.
