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Clinical Research Coordinator (50151)

Key Facts

Remote From: 
Full time
Expert & Leadership (>10 years)
English

Other Skills

  • •
    Quality Control
  • •
    Team Building
  • •
    Professionalism
  • •
    Communication
  • •
    Adaptability
  • •
    Time Management
  • •
    Teamwork
  • •
    Personal Integrity
  • •
    Detail Oriented
  • •
    Mentorship

Roles & Responsibilities

  • Ability to adhere to FDA guidelines, ICH and GCP, and study protocols in clinical trial activities.
  • Experience supporting subject recruitment, screening, enrollment, informed consent, data collection, and source document maintenance (CRFs) per protocol.
  • Strong documentation and data management skills, including adverse event reporting and timely data entry.
  • Willingness and ability to travel to oversee studies at multiple sites and work on-site at the Aventura clinic.

Requirements:

  • Perform research coordinator duties to conduct clinical trials per FDA guidelines and study protocols, including recruitment, screening/enrollment, consent, data collection, and site monitoring.
  • Maintain source documents and CRFs, document laboratory/histology procedures, ensure proper labeling of specimen images, and file all study-related documents.
  • Ensure studies are conducted per protocol and GCP/ICH/FDA guidelines; ensure IRB/SOP compliance; monitor timelines and keep folders updated.
  • Assist physicians with procedures, patient education, post-treatment care, pre/post-treatment photography, room setup, and coordinate study schedules; travel to oversee multi-site studies and train other team members.

Job description

Who We Are:

Platinum Dermatology Partners is a network of high-quality dermatology clinics that focus on collaborative and innovative ideas to drive growth. We offer general dermatology, cosmetic, medical, plastic surgery, and cancer screening treatments. We have over 145 clinics, over 350 providers, and more than 2300 employees in clinics across Texas, Arizona, California, Nevada, and Florida. We are a rapidly growing company that allows our doctors to focus on providing exceptional care without worrying about the operational side of the business. Our core values focus on collaboration, ownership, respect, excellence, authenticity, and integrity. Our purpose is to empower the practice of exceptional dermatology.

Company Conformance Statements:

In the performance of their respective tasks and duties, all employees are expected to conform to the following:

  • Perform quality work within deadlines with or without direct supervision.
  • Interact professionally with other employees, customers, and suppliers.
  • Work effectively as a team contributor on all assignments.
  • Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.

Job Summary:

This role is responsible for perfoming all administrative aspects of clinical trial research studies based upon needs and goals of the Research Program. Tasks include, but are not limited to, recruitment completion of database logs for pre-screens, scheduling, consents, and close out of study per protocols. Provide support to PI/sub-I as requested at multiple clinics. This role is in the clinic at the Aventura location. (This is not a remote role)

Responsibilites:

  • Perform all research coordinator duties required to adhere to FDA guidelines and study protocols, and facilitate the daily clinical trial activities required to conduct the study including, but not limited to:
    • Subject recruitment, screening and enrollment
    • Collection of laboratory specimens, informed consent and other data from subject.
    • Maintenance of source documents including CRF (case report form) completion and review for accuracy
    • Participation in site monitoring visits and audits.
    • Documentation of laboratory and histological procedures. Ensure accurate labeling of slide photos.
    • Filing and maintenance of all study related documents.
    • Documents adverse events and notifies principal investigator and appropriate agencies. Notifies Director, sponsor and IRB of any serious adverse events.
    • Assist physician with all procedures to include excisions, injections, laser treatments, wound care, post-op care and dressing changes. Set up exam room for specific procedure as indicated.
    • Provide patient education and literature. Take pre- and post-treatment pictures.
    • Clean pack and sterilize instruments. Assists in cleaning rooms.
    • Monitor physician’s schedule to maintain timely flow.
  • Ensure studies are conducted according to protocol and in accordance with GCP, ICH and FDA guidelines. Ensure IRB guideline and SOP compliance.
  • Ensure all study timelines are met and study folders are kept updated and accurate.
  • Work closely with the physician(s) and medical provider(s) assigned to the study.
  • Oversee, participate and enter in timely manner data entry, perform study monitoring in peer-to-peer inter- rated methodology.
  • Enter all data within 2 days of study visit by Research Coordinators and query resolution performed within 2 days of query. Random QC monitoring process to be established by Director and conducted by Research Coordinators in peer-to-peer inter-rated methodology.
  • Perform other tasks/duties as requested or assigned by PI/sub-I and Director.
  • Must be able to travel to oversee studies in multiple sites as required.
  • Coordinate study schedules with practice personnel.
  • Train other team members on study protocols and visits.

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