Clinical Research Coordinator II

2 weeks ago

Charlotte, North Carolina, United States Javara Full time

***This position requires a minimum of two years of patient-facing experience in clinical trials. The annual salary range starts at $59,000 and is based on experience.

Overview:

The Clinical Trial Navigator (CTN) II is a dedicated research professional tasked with the oversight and management of clinical trials, operating under the guidance of the Clinical Trial Operations Manager and the Principal Investigator or their delegate. The CTN II is responsible for executing and coordinating research study protocols to ensure the effective administration of clinical trials.

Key Responsibilities:

  • Uphold the mission of Javara, prioritizing patient safety and well-being while fostering a culture of integrity and excellence for all stakeholders.
  • Oversee clinical research studies, ensuring compliance with Javara's Standard Operating Procedures (SOPs), partner SOPs, Good Clinical Practices (GCPs), study protocols, clinical trial agreements, and relevant regulations.
  • Coordinate participant visits and study-related activities according to established protocols and schedules, which may include arranging travel logistics for participants; ensure timely reminder communications (via phone, text, or email) to enhance participant attendance and adherence; identify and engage potential patients; prepare necessary materials for study visits.
  • Conduct clinical research visits/procedures as per protocol requirements, which may involve collecting vital signs, medical history, and administering questionnaires.
  • Ensure the integrity of scientific data while safeguarding the rights, safety, and well-being of research participants.
  • Navigate the healthcare and clinical research landscape to provide seamless care for trial participants, engage investigators in daily research activities, and promote clinical research within the healthcare system.
  • Develop and implement a patient engagement strategy to identify and recruit suitable research participants for clinical studies.
  • Facilitate and document the informed consent process as delegated by the Principal Investigator, adhering to Javara's SOPs.
  • Collect, process, and ship biological samples such as blood and urine as required by study protocols, following Javara's SOPs and laboratory guidelines.
  • Dispense investigational products and research supplies responsibly, in accordance with study requirements and regulations.
  • Educate the research team and healthcare staff on study-related procedures, including investigational product dosing and monitoring.
  • Assist in integrating clinical research as a viable care option within the healthcare system.
  • Monitor and report adverse events and protocol deviations to the appropriate parties in compliance with Javara's SOPs.
  • Understand regulatory requirements, maintain documentation, and assist with regulatory submissions as needed.
  • Create and maintain source documents and ensure accurate documentation in medical records.
  • Complete and manage case report forms and respond to queries regarding study data in accordance with FDA regulations.
  • Prepare for and participate in routine monitoring visits, audits, and inspections.
  • Ensure that study documentation is ready for audits and inspections.
  • Support additional projects as directed by the Director/Associate Director of Clinical Research Operations.
  • Collaborate with the Manager of Clinical Trial Operations to align all functions with the company's strategic mission and values.
  • Exhibit the ability to manage multiple clinical trials and assist team members in high-volume or complex trials.

Qualifications:

Required:

  • Bachelor's degree or equivalent experience in a related field.
  • A minimum of 4 years of experience in healthcare or a related area.
  • Familiarity with study-specific protocols and regulations governing clinical trials.
  • Ability to manage multiple priorities effectively while providing excellent client service.
  • Demonstrated competency in clinical trial conduct and collaboration with various stakeholders.
  • Strong time management, problem-solving, planning, and organizational skills.
  • Excellent interpersonal, written, and verbal communication skills; proficient in educating participants about the informed consent process and study phases.
  • Ability to work independently or as part of a team, with the capacity to train junior staff as needed.
  • Proficiency in Microsoft Office applications and standard office equipment.

Preferred:

  • Bachelor's degree in a relevant field.
  • Clinical Research Coordinator Certification from the ACRP.

Work Environment:

This role is conducted in a professional setting with a light to moderate noise level.

Physical Demands:

Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions. The role requires regular use of hands for tasks such as reaching and handling objects, as well as the ability to stand, walk, and sit frequently. Occasional lifting of up to 25 pounds may be necessary.

Travel: This position may require up to 25% travel for short trips to various research centers and medical practices.

Pre-Employment Screening: A drug screen and background check are mandatory.

This job description outlines the primary functions of the position and is not intended to be an exhaustive list of all duties and responsibilities.

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