Clinical Research Support Specialist

2 weeks ago

Orlando, Florida, United States CHARTER RESEARCH Full time
Job Overview

Company Background
Charter Research is a rapidly expanding clinical research organization dedicated to the advancement of medical science. Our focus is on delivering exceptional experiences for our participants while implementing effective recruitment strategies for our sponsors. We are committed to building a cohesive team that embodies our values and mission.


Position Summary
The Clinical Research Support Specialist plays a vital role in facilitating the daily operations of clinical trials aimed at evaluating the safety and efficacy of new pharmaceuticals. This position involves collaboration with the Principal Investigator (PI) and Clinical Research Coordinators (CRCs) to ensure the smooth execution of clinical research projects. Team members are expected to adhere to Good Clinical Practice (GCP) standards while managing and maintaining essential documentation.


Key Responsibilities

  1. Thoroughly review all assigned studies by examining protocols, participating in investigator meetings, and coordinating with the PI and CRC.
  2. Assist in the execution of clinical research studies, ensuring compliance with study protocols, including patient visit requirements, informed consent processes, and laboratory procedures.
  3. Educate patients and their families about the clinical trial process and the specifics of their involvement.
  4. Support the PI and CRC in evaluating patient eligibility and oversee the enrollment process, ensuring informed consent is obtained and documented appropriately.
  5. Coordinate and perform patient visit procedures, including blood draws, vital sign checks, ECGs, and specimen processing as instructed.
  6. Ensure that all study visit procedures comply with the clinical trial protocol and GCP, following the site's Standard Operating Procedures (SOPs).
  7. Maintain an adequate supply of study materials necessary for conducting clinical trial visits and procedures.
  8. Communicate any clinical trial issues to the PI and CRC, facilitating documentation and communication within the organization and with external sponsors and vendors.
  9. Keep all source documentation current and compliant with ALCOA-C standards.
  10. Assist the PI and CRC in maintaining close communication with sponsors and/or Clinical Research Associates (CRAs) to support study monitoring and data management.
  11. Respond to all monitor and sponsor inquiries promptly, as directed by the PI and CRC.
  12. Help track patient enrollment status and provide timely updates to patients regarding their participation.
  13. Prepare for and participate in quality assurance audits conducted by sponsors or regulatory agencies as directed by the PI and CRC.
  14. Perform additional duties as assigned by the PI and CRC to ensure the effective conduct of clinical trials.

Qualifications

  1. Strong interpersonal and customer service skills.
  2. Familiarity with medical terminology.
  3. Exceptional organizational abilities and attention to detail.
  4. Effective verbal and written communication skills.
  5. Ability to work independently and collaboratively within a team.
  6. Capability to manage multiple tasks simultaneously and adapt to changing responsibilities.
  7. High level of integrity and ability to maintain confidentiality in accordance with HIPAA guidelines.
  8. Phlebotomy skills are advantageous.

Education and Experience

  1. Fluency in both English and Spanish is required for specific locations.
  2. A Bachelor's degree is preferred, ideally in psychology, biology, health sciences, or a related field.
  3. Relevant certifications such as Medical Assistant (MA), Certified Phlebotomy Technician (CPT), or Licensed Practical Nurse (LPN) are a plus.
  4. 1-3 years of relevant experience is required.

Physical Requirements

  1. Ability to sit for extended periods while working on a computer.
  2. Capability to stand, bend, and reach for prolonged periods.
  3. Physical ability to assist patients as needed, including lifting up to 30 pounds.

Charter Research is an equal opportunity employer, providing employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable laws.

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