Clinical Research Coordinator
Posted on: March 19, 2020
Job Description For: CLINICAL TRIAL NAVIGATOR Location:
Summary/Objective: This position is responsible for managing the
conduct of assigned clinical trial activities. This position
reports directly to the Director/Associate Director of Clinical
Trial Operations. Essential Responsibilities: Promoting the mission
of Javara with a primary guiding principle of research participant
safety, research participant well-being, and doing so with
integrity and excellence to those we serve. The Clinical Trial
Navigator (CTN) is a specialized research professional, responsible
for the coordination and administration of clinical trials under
the direction of the Director/Associate Director of Clinical
Research and the Principal Investigator or designee. The CTN
implements and coordinates research study procedures for the
successful management of clinical trials. The CTN position requires
someone who is knowledgeable of study specific protocols as well as
regulations and guidance for the conduct of clinical trials.
- Manage clinical research studies and adhere to Javara Standard
Operating Procedures (SOPs), our healthcare partner's SOPs, Good
Clinical Practices (GCPs), study protocols, clinical trial
agreements, and regulations governing clinical research.
- Ensure scientific integrity of data and protect the rights,
safety and well-being of research participants.
- Navigate the resources and workflow within the healthcare and
clinical research environment to ensure seamless care for the
clinical trial participant, to engage investigators in research
daily and to promote clinical research within the healthcare
- Create and implement a patient engagement plan to identify and
contact potential research participants, and then screen and enroll
participants in suitable clinical research studies.
- Conduct and document the informed consent process when
delegated to do so by the Principal Investigator in compliance with
- Demonstrate competency with respect to both clinical trial
conduct and specific research studies with investigators,
healthcare partners, sponsor, CRO, research team, and potential and
active research participants.
- Coordinate research participant visits and study related
procedures according to study protocol windows and study team
schedules. This may involve handling travel logistics for research
- Ensure reminder communications (phone, text or email as
requested by the participant) are conducted to promote show rate
- Conduct clinical research study visits/procedures per protocol
requirements. This may require obtaining vital signs, height,
weight, EKG's, spirometry, medical history, medications, adverse
events and labs as well as administering questionnaires and
- Collect, process and ship any bodily samples such as blood and
urine as required per protocol in compliance with Javara's SOPs and
- Dispense investigational product and other research study
supplies in an accountable manner in accordance with study
requirements, institutional requirements, investigator approval and
- Inform and educate the research team and healthcare system
staff regarding study related procedures including IP dosing and
- Assist with Integrating clinical research as a care option
within the healthcare system.
- Monitor and report adverse events, serious adverse events and
protocol deviations to the investigator, sponsor and IRB in
compliance with Javara's SOPs.
- Know and understand regulatory requirements, maintain files and
documents, and assist the Regulatory Navigator/Manager of Trial
Activation with regulatory submissions.
- Create source documents and document appropriately in source
documents and /or medical records (paper, EMR, e-source) per ALCOA:
data is attributable, legible, contemporaneous, original and
- Complete and maintain case report forms (paper or electronic)
and answer queries regarding study data per FDA regulations,
clinical trial agreement and protocol requirements.
- Prepare and participate in routine monitoring visits, internal
and external audits, and inspections.
- Ensure study documentation is audit ready in the event of
monitoring, audits and inspections.
- Assist with additional projects as requested by Director/
Associate Director of Clinical Research Operations.
Work Environment: This job operates in a professional environment.
This role routinely uses standard office equipment such as
computers, laptops, tablets, phones, photocopiers, and printers.
Position Type: This is a full-time, exempt position. Travel: This
position may involve travel between research centers, medical
practices, and the Javara main office. This position may involve
traveling to meetings and some of the meetings may require air
travel. Travel within the USA or to other countries for 2-3-day
trips may be required at least 6 times per calendar year. Education
or Equivalent Experience:
- Bachelor's degree preferred or equivalent experience.
- Work experience in a related field preferred.
- Able to use standard office software, as well as proprietary
applications unique to the clinical trial industry.
- Must present a pleasant, professional, and helpful demeanor
- Exceptional planning and organizational skills.
- Highly motivated to provide exceptional service.
- Able to work autonomously or as part of a team.
- Able to manage challenging situations and conflicts and resolve
- Excellent interpersonal skills with proven written,
presentation and verbal competencies.
- Able to multi-task and manage multiple priorities while
demonstrating excellent customer service behavior
Refer to ACRP Core Competency Guidelines for CRC's:
Please note this job description is not designed to cover or
contain a comprehensive listing of activities, duties or
responsibilities that are required of the employee for this job.
Duties, responsibilities and activities may change at any time with
or without notice. About Javara: Javara is an integrated research
organization (IRO) that advances value by integrating clinical
research within the healthcare ecosystem. Javara brings better
outcomes for patient centered care, better economic results,
improved access to cutting edge therapies and a more predictable
research delivery model to the biopharmaceutical sector. EOE
Statement: Javara is an equal employment opportunity employer. All
qualified applicants will receive consideration for employment
without regard to race, color, religion, gender, national origin,
disability status, protected veteran status or any other
characteristic protected by law.
Keywords: Javara, Albany , Clinical Research Coordinator, Healthcare , Albany, Georgia
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