Description
Consultant, Bilingual Clinical Research Associate, Pharmaceutical Role Summary The CRA/Field Monitor Contractor will provide clinical monitoring services across multiple clinical trials. The individual will be responsible for overseeing the conduct of assigned clinical trial sites, ensuring that the clinical trials are conducted, recorded, and reported in accordance with the applicable protocol, standard operating procedures ("SOPs"), International Conference on Harmonization (ICH)/Good Clinical Practice ("GCP") guidelines and the applicable regulatory requirements.
Essential Job Functions and Desired Accomplishments:- Perform the tasks as outlined in the most current ICH E6 Good Clinical Practices (ICH E6 5.18 - Monitoring) and according to applicable Policies and Procedures
- Comply with all requirements as defined in CFR Title 21 Part 312
- Thorough understanding of the protocol and its requirements for each assigned study
- Perform qualification visits, site initiation visits, interim monitoring visits, and site close-out activities, as assigned by the client and per the study-approved clinical monitoring plan in accordance with GCP and SOPs
- Ensure 100% compliance with the submission of monitoring reports and follow-up letters within the specified timelines as outlined in the clinical monitoring plan and per SOPs
- Act as the point of contact for assigned sites as it relates to study conduct and provide updates to study management and line management as required
- Attend project and field manager meetings, training sessions, and other required study-related meetings, e.g., investigator meetings, as requested
- Ensure compliance with timely submission of essential documents to the TMF and ensure ongoing contemporaneous inspection readiness of site-level TMF for assigned sites
- Ensure compliance with all Clinical Monitoring Plan requirements for assigned protocols
- Ensure adherence to requirements and processes related to issues & deviations management and escalation
- Ensure 100% compliance with required training within specified timelines
- Comply with Travel Policy; and submit expense reports within thirty (30) days
- Ensure accurate and timely reporting and completion/submission of timesheets
Education/Qualifications/Certifications (Knowledge, Skills, Abilities, etc.) - 7+ years of experience as a Field Monitor or equivalent title
- 1 + year of contract monitoring preferred
- Fluent in Spanish
- BA/BS degree or equivalent experience
- CNS therapeutic area experience preferred
- Ability to travel up to 80%
- Proven knowledge of clinical trials and expertise in clinical monitoring
- Excellent verbal, written, and presentation skills
- Exceptional working knowledge of clinical research, GCP/ICH, and local laws and regulations
- Proven site management ability
- Strong to expert level computer literacy, e.g., MS Office, MS Teams, various clinical IT applications
Term & Start- 12+ month contract with the opportunity to extend
- The candidate must be local to Miami, FL area
- 80% Travel - Expenses Covered
- Healthcare benefits available
