Clinical Research Coordinator - Winter Park, FL

Advanced Dermatology and Cosmetic Surgery•Casselberry, FL

7d•Hybrid

About The Position

Advanced Dermatology and Cosmetic Surgery (ADCS) is seeking a Clinical Research Coordinator (CRC) to join their team. The CRC is a specialized research professional who works under the supervision of the Principal Investigator (PI) and reports directly to the Director of Clinical Research. The CRC plays a critical role in supporting and coordinating daily clinical trial activities, ensuring compliance with federal regulations and sponsoring agency policies. This role involves close collaboration with the PI, department, sponsor, and institution to manage the administrative, financial, and personnel aspects of clinical studies.

Requirements

Knowledge of ADCS policies, quality assurance policies, and applicable government regulations and standards.
Knowledge of electronic health record access-level privileges and responsibilities.
Ability to practice confidentiality and follow HIPAA regulations.
Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information.
Ability to recognize problems and effectively problem-solve, using guidance when necessary.
Knowledge of medical terminology and ability to use it appropriately.
Ability to manage time efficiently, prioritize, multi-task, and adapt to change.
Ability to maintain a high level of accuracy in all documentation and job duties.
Ability to perform essential job duties within the scope of education and training.
Skilled in typing/keyboarding.
Skilled in using computers.
Ability to read and interpret work-related documents.
Ability to write routine reports and correspondence.
Ability to listen, speak, and interact effectively with all patients and co-workers.
Ability to practice professional telephone etiquette.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to understand and follow instructions, both written and verbal.
Strong problem identification/resolution skills.
Ability to manage complications involving several variables.

Nice To Haves

Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) Certification from SoCRA or ACRP
Good Clinical Practice (GCP) preferred
International Air Transport Association (IATA) Training preferred

Responsibilities

Coordinates with Principal Investigator, department, and administration to ensure clinical research activities comply with Federal Regulations and sponsoring agency policies.
Assists the PI in study feasibility assessments.
Reviews and comprehends study protocols.
Attends investigator meetings as required.
Collaborates with the PI to prepare Institutional Review Board (IRB) and other regulatory submission documents.
Prepares study materials such as informed consent documents, source documents, enrollment logs, and drug/device accountability logs.
Establishes and organizes study files, including regulatory binders and source documentation.
Develops a thorough understanding of the protocol, including proceedings, timelines, inclusion/exclusion criteria, and confidentiality.
Assists the PI in communicating study requirements to all involved individuals and provides training and tools for study team members.
Collects documents for study initiation and submission to the sponsor (e.g., FDA Forms 1572, CVs).
Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements.
Conducts or participates in the informed consent process, including discussions with research participants and answering questions.
Obtains appropriate signatures and dates on forms and ensures amended consent forms are implemented.
Develops advertising and informational materials for subject recruitment.
Identifies and contacts potential subjects for recruitment, schedules appointments, and maintains enrollment logs.
Screens subjects for eligibility based on inclusion and exclusion criteria.
Coordinates participant tests and procedures, draws blood, and collects urine samples as specified by the protocol.
Prepares specimens for shipping to laboratories.
Collects data and performs assessments specified in the protocol (e.g., vitals, questionnaires, EKG, photos).
Ensures timely completion of Case Report Forms and maintains study timelines.
Maintains adequate inventory of study supplies.
Follows sponsor protocol for Investigational Drug/Device Accountability if handling investigational drugs/devices.
Dispenses study drug to study patients.
Completes study documentation and maintains study files in accordance with sponsor requirements.
Tracks enrollment status and documents dropout information.
Retains all study records in the Regulatory binder according to sponsor requirements.
Maintains effective and ongoing communication with sponsor, research participants, and PI.
Assists the PI in submitting accurate and timely closeout documents to Federal agencies and the sponsoring agency.
Arranges secure storage of study documents for the contracted length of time.