Clinical Trials Management Specialist

2 weeks ago

Austin, Texas, United States Austin Clinical Trial Partners Full time
Position Overview: Clinical Trials Management Specialist at Austin Clinical Trial Partners

The Clinical Trials Management Specialist (CTMS) is responsible for the coordination and oversight of clinical research studies under the supervision of the Principal Investigator. This role encompasses the planning, execution, and management of both research and administrative functions to ensure the effective conduct of clinical trials. The position involves a variety of administrative responsibilities that necessitate analytical skills, sound judgment, and a comprehensive understanding of study-specific protocols.

Key Responsibilities

  • Oversee approximately six to eight clinical trials from both administrative and clinical perspectives
  • Comply with Research Standard Operating Procedures (SOPs)
  • Strictly adhere to Good Clinical Practices and specific study protocols
  • Ensure data accuracy and integrity while protecting the rights and welfare of patients involved in clinical trials
  • Engage with patients regarding study protocols and confirm informed consent documentation
  • Provide written communication concerning patient participation to relevant parties (e.g., supply a copy of the signed informed consent)
  • Inform the patient's referring physician about their involvement in studies upon request
  • Conduct patient meetings during each visit and remain available to address any questions or concerns related to the study
  • Dispense study medications in a professional and accountable manner according to protocol requirements
  • Collect, process, and send biological samples during scheduled patient visits
  • Perform ECGs and document patients' vital signs
  • Schedule all patient research visits and procedures in accordance with protocol specifications
  • Complete and maintain case report forms following FDA guidelines, ensuring they are reviewed against the patient's medical records for completeness and accuracy
  • Administer questionnaires and diaries as required by the protocol
  • Ensure proper documentation and reporting of both non-serious and serious adverse events
  • Review all laboratory results upon receipt and follow protocol procedures for any abnormal findings
  • Share all laboratory results with relevant physicians for clinical significance evaluation and file results in the patient study binder
  • File and maintain all regulatory documents
  • Prepare for monitor visits ahead of the monitor's arrival
  • Perform any other assigned duties as necessary

Education & Experience Requirements

  • A minimum of a 4-year college degree
  • At least two years of experience in a clinical research coordinator role
  • Prior experience with CNS clinical trials is highly desirable
  • Experience in phlebotomy and laboratory processing is essential

Qualifications & Skills

  • Ability to understand and interpret information from professional journals, technical procedures, or governmental regulations
  • Capable of effectively communicating information and responding to inquiries from physicians, staff, and patients
  • Familiarity with Good Clinical Practices and regulations essential for protecting human subjects and conducting clinical research
  • Understanding of International Air Transport Association (IATA) regulations for transporting Dangerous Goods
  • Experience in phlebotomy and laboratory processing is required
  • Ability to work collaboratively in a team and adapt to various situations
  • Consistent professionalism and meticulous attention to detail
  • Excellent verbal and written communication skills, along with exceptional interpersonal skills with patients, staff, and other healthcare professionals
  • Occasional travel may be required for investigator meetings
About Austin Clinical Trial Partners

Our Mission:
We prioritize people by delivering expert care with compassion, professionalism, and ethics. As a united team, we strive to offer hope and advancements in medical knowledge and treatment.

Our Goal:
Dr. Garcia and the team provide expert care in a compassionate, secure, and welcoming clinical environment. With more than 30 years of clinical experience and two decades in clinical research, Austin Clinical Trial Partners collaborate with our patients, trial participants, and study partners to achieve successful results.

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