Note: The job is a remote job and is open to candidates in USA. Javara is an integrated research organization that advances value by integrating clinical research within the healthcare ecosystem. They are seeking a Clinical Research Patient Engagement Specialist to ensure patient safety and regulatory compliance while engaging with participants for psychiatric clinical trials.
Responsibilities
- Promote the mission of Javara with a primary guiding principle of patient safety and well-being and building and maintaining a culture that combines the highest standard of integrity with excellence to all those Javara serves
- Ensure patient engagement team safety, regulatory compliance, and that Javara’s standard operating procedures and guidelines are followed, as well as ensuring that it complies with all FDA, ICH/GCP Guidelines and state and local laws and regulations
- Oversee uniform application of patient engagement technology systems, policies, and procedures
- Conduct telephone and in-person prescreening of prospective participants for psychiatric and central nervous system (CNS) clinical trials, with a primary focus on Major Depressive Disorder (MDD)
- Build trust and establish rapport with individuals experiencing depression and other mental health conditions while maintaining empathy, professionalism, and confidentiality
- Assess eligibility using protocol-specific inclusion and exclusion criteria and accurately document screening outcomes
- Identify and appropriately escalate participant safety concerns, including suicidal ideation or psychiatric deterioration, according to site policies and study protocols
- Collaborate closely with investigators, coordinators, therapists, and referral sources to facilitate timely participant enrollment
- Maintain a compassionate, patient-centered experience while meeting enrollment goals and study timelines
Skills
- Bachelor's degree in psychology, social work, counseling, nursing, or a related healthcare field preferred (or equivalent relevant experience)
- Minimum of 2 years of professional experience working directly with adults diagnosed with Major Depressive Disorder or other serious mental health conditions
- Experience in one or more of the following settings: Outpatient behavioral health, Psychiatric practice, Community mental health, Inpatient psychiatry, Crisis services, Clinical research involving psychiatric populations
- Demonstrated ability to communicate with patients experiencing depression, anxiety, or other psychiatric symptoms with empathy and professionalism
- Experience conducting structured interviews, patient assessments, or clinical screening
- Strong documentation and organizational skills with exceptional attention to detail
- Comfortable working toward recruitment and enrollment goals in a fast-paced environment
- Ability to adhere to and apply SOP's, GCP's guidelines and regulations pertaining to clinical trials
- Ability to take initiative, problem solve, and work independently
- Accountable, dependable and strong commitment to quality of work
- Strong written and verbal communication skills
- Previous clinical research experience, particularly psychiatric or CNS studies
- Familiarity with DSM-5 diagnostic criteria for Major Depressive Disorder and common psychiatric comorbidities
- Experience administering or supporting standardized psychiatric assessments
- Knowledge of Good Clinical Practice (GCP) guidelines
- Experience working with electronic medical records and clinical trial management systems
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