Regional CRA/Monitor (EST) (Remote)

Job Description:

The Clinical Research Associate conducts site monitoring responsibilities for Clinical trials, according to Standard Operating Procedures, ICH guidelines, and GCP.

Essential Duties and Responsibilities:

• Manage and monitor site activities for assigned clinical studies, working individually or co-monitoring with other Clinical Research Associates (CRAs).
• Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits.
• During monitoring visits, the CRA ensures compliance with the protocol and applicable Company or Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines.
• Perform site evaluation visits of potential investigators. Evaluate the capability of the site to successfully manage and conduct the clinical study.
• Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities.
• Assist in resolving any issues to ensure compliance with site file audits.
• Direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management.
• Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Perform investigational product inventory. Ensure return of unused materials to designated location or verify destruction as required.
• Serve as primary contact with the site; coordinate all correspondence; ensure timely transmission of clinical data with the study site.
• Perform study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
• Ensure internal and study-related trainings are completed per Lotus and/or study timelines.
• Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan (MP) for Confirmation Letters, Follow up Letters and Monitoring Visit Reports (MVR).

Education and/or Experience:

• Bunionectomy experience required
• Ability and willingness to travel up to 75% of the time (land and air).
• College degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• In lieu of the university /college degree or certification requirement, a minimum of5 years of relevant clinical research experience in health care, pharmaceutical, or CRO settings may be considered and minimum of 2 years field monitoring experience as a CRA.
• Phase I experience preferred
• Valid Driver’s License.

Skills and Abilities:

• Proficient knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process.
• Experience using electronic CRF platforms and processes.
• Exceptional attention to detail.
• Ability to interact effectively within and across team environments.
• Excellent organizational skills.
• Proficient computer skills with good working knowledge of a range of standard computer software required (e.g., email, document, spreadsheet, and presentation software).