Oncology Clinical Trials Coordinator

2 weeks ago

Rockville, Maryland, United States Maryland Oncology Full time

Position Overview:
Are you seeking a fulfilling opportunity in the healthcare sector? Maryland Oncology Hematology is on the lookout for exceptional talent to join our dedicated team. We pride ourselves on delivering the highest standard of cancer care in a compassionate environment.

Role Summary:
The Clinical Trials Coordinator is pivotal in the recruitment, screening, and enrollment of patients in clinical studies. This role also entails managing and supervising patient visits in alignment with research protocols. Key responsibilities include ensuring adherence to protocol compliance for all enrolled participants, facilitating the informed consent process, and collaborating with healthcare professionals for ongoing assessments and documentation. The coordinator serves as a resource for training clinic staff and resolving complex issues related to the research process, as well as contributing to process enhancements and standard operating procedures. Additionally, the coordinator compiles and reports on protocol activities, accrual data, and financial information, ensuring research quality by adhering to regulatory standards and compliance programs.

Key Responsibilities:

  • Evaluate potential participants for eligibility based on study protocols. Present trial information to patients, assist in the informed consent process, and facilitate patient enrollment in clinical trials.
  • Manage patient care in accordance with protocol specifications. This may include dispensing investigational drugs and maintaining accountability for such substances. Ensure that physician orders align with protocol requirements and oversee the preparation and shipping of lab specimens.
  • Collaborate with physicians to monitor patient conditions, document adverse events, and assess protocol compliance, while actively participating in data collection for all subjects.
  • Prepare essential study documentation, including protocol worksheets, adverse event reports, and institutional review board submissions.
  • Maintain regulatory documents in compliance with established standard operating procedures and relevant regulations. Engage in scheduling monitoring and auditing visits, interacting with monitors and auditors as necessary.
  • Participate in mandatory training and educational programs, potentially educating clinic staff on clinical research processes. Work with staff to develop action plans and identify opportunities for performance improvement.
  • Compile and report on protocol activities, accrual trends, and research financial data to practice administration and physicians. Review protocol-specific billing guides and submit necessary billing information.
Qualifications:
Education:
  • Associate's degree in a clinical or scientific discipline is required; a Bachelor's degree is preferred.
  • A minimum of three years of experience in a clinical or scientific field is required, with a preference for oncology experience.
  • Certification from SoCRA or ACRP is preferred.
Business Experience:
  • Proficiency in Microsoft Office applications.
  • Experience collaborating with physicians is preferred.
  • Background in clinical research is advantageous.
Skills:
  • Exceptional communication and organizational skills.
  • Ability to manage multiple tasks effectively.
  • Strong time management capabilities.
  • Interpersonal skills to engage with diverse individuals.
  • High attention to detail and ability to thrive in a fast-paced environment.
  • Basic clinical assessment skills may be required.
Working Environment:
This position is primarily office-based, with potential exposure to communicable diseases and other conditions typical of an oncology/hematology clinic. Reasonable accommodations will be provided for individuals with disabilities to perform essential job functions. The role may involve standing and walking for extended periods and occasionally lifting items weighing up to 40 lbs.

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