About the Company:
Humannity Medtec’s Clinical Affairs team is currently accepting applications for a Clinical Research Associate II/III for a full-time position (hybrid) based in Valencia, CA. This position plays an essential role in the development and implementation of clinical research projects by supporting the clinical activities of assigned studies.
About the Role:
Responsibilities include the planning, execution and interpretation of clinical research and data collection activities. This position plays a key role in the development and execution of pre-clinical, First in Human and pivotal trials intended to support regulatory registration of novel medical devices, as well as physician-initiated and company-sponsored clinical trials.
Responsibilities:
- Ability to autonomously manage all clinical activities related to the execution of US/OUS Class 3 medical device clinical trials consistent with GCP and other regulatory and compliance requirements.
- Drive activities related to the execution of a clinical trial, from protocol study design to final clinical study reporting for one or more studies.
- Support study efforts in collaboration with internal stakeholders as well as outside vendors involved in the clinical trials (e.g., central labs, CROs).
- Assist Study Manager during study audits.
- Along with other Clinical team members, contribute to and assist with the preparation of protocols and Case Report forms, finalization of monitoring and data management options (either in-house or contracted to a CRO), development of recruitment strategies, the provision of clinical trial materials, and trial management.
- Support Study Manager in coordinating the smooth monitoring of all trials, establishing audit procedures and ensuring timely data processing.
- Participate in the training of Field Clinical Engineers on study protocols.
- Provide back-up support for preclinical studies and other projects, as needed.
Qualifications:
BS or MS degree in Life Sciences, Engineering or a related field. Active SoCRA or ACRP Certification. 6 or more years of experience in a CRA II/III role working with Class III Medical Device clinical trials (FIH, Pivotal, Post-Market) from start-up to close-out (preferably in Neuromodulation).
Required Skills:
- Strong writing skills (emails, letters, reports, publications, independent and proactive internal and external communications, submission materials including synopsis, protocol, study reports).
- Proven track record of effectively working with clinical sites.
- Experience with Class 3 medical device BIMO audits, QC audits and QA check reports.
- Experience working with Data Management on query resolutions.
- Experience in reviewing email alerts for AEs, deviations, withdrawals, deaths and informing the Study Manager.
- Experienced in reviewing clinical data and completing internal CRA analysis fields, classification of AEs and timely reporting of UADEs to Study Manager.
- Experienced in planning and participating in investigator meetings, Steering Committee and DSMB meetings.
- Excellent knowledge of clinical study guidelines (FDA, ICH and GCP).
- In-depth understanding of the clinical trials process Trial Master File Management.
- Understands technical details and seeks out opportunities for advancing technical knowledge.
- Ability to utilize various electronic systems and software- intermediate computer skills required.
- Ability to travel as required less than 20% as needed.
