Clinical Research Associate II (Dermatology) - West Coast Based (Remote)

Overview

The Clinical Research Associate conducts monitoring activities to verify the adequacy, reliability, and quality of data collected at assigned clinical sites; ensures study conduct compliance, subject safety, data integrity, and subject confidentiality are being protected.

Responsibilities

Under the direction and as requested by the Lead Clinical Research Associate of assigned studies, the Clinical Research Associate (CRA):

• Ensures assigned studies are conducted in compliance with the currently approved Protocol(s)/Amendment(s), SOPs, Code of Federal Regulations (CFR), Good Clinical Practice (ICH GCP), and local or country regulations
• Participates in Investigator feasibility and site selection process by contacting sites to obtain feasibility information, including debarment and regulatory observations/citations
• Conducts site qualification (pre-study), site initiation, routine interim, and close-out monitoring visits in accordance with the Clinical Monitoring Plan (CMP) for assigned studies and sites
• Travels to study sites to conduct onsite visits as required
• Participates, kick off/Investigator/study team meetings as needed
• Ensures assigned sites are following the appropriate IRB/EC reporting policies
• Confirms site qualifications of study personnel delegations
• Verifies that all delegated study staff at assigned sites are trained/certified and maintain compliance with requirements of the study protocol, informed consent process, data collection requirements, Investigational Product/ Investigational Medical Device (IP/IMP) accountability/ supply management, and safety reporting requirements
• Provides sites with study and protocol training as needed
• Maintains good rapport with site investigator(s) and staff, proactively scheduling appointments during onsite visits and remote check-ins as needed
• As needed, may prepare and/or assist with site submissions to the Independent Ethics Committees (central and local) and to Competent/Regulatory Authorities
• Ensures all essential documents required for study startup are at the site and filed in the Investigator Site File prior to study startup
• Ensures adequacy, reliability, and quality of all study data at assigned sites by performing source data review, source document verification, and query resolution
• Ensures subject safety, data integrity, and subject confidentiality are maintained
• Track sites recruitment
• Completes IP accountability and tracks re-supply of IP and ancillary supplies
• Documents visit findings in monitoring visit reports and sends site visit and follow-up letters within the timelines and parameters outlined in the applicable SOPs and CMP
• Ensures all protocol deviations (PDs) are captured and managed according to the applicable SOP and study specific plans
• Ensures timely safety reporting from the sites (i.e., SAEs, AESIs, pregnancy)
• Provides study progress updates at study team meetings, including achievements, issues noted, and proposed solutions
• Assists with ISF review and TMF completeness activities as needed
• Follows up on site action items and queries, including those related to potential safety issues or protocol deviations
• Maintains trackers of site deviations (i.e., identification, reporting, CAPAs, etc.) upon request

Required Experience

• Minimum of 3 years of thorough experience in clinical research in CRO or pharmaceutical environment with a minimum 2 year of CRA field experience
• Field experience with Dermatology/Aesthetic studies required, as well as prescriptions studies and medical device experience
• Prior Study Coordinator experience a plus
• Experience with Trial Master File and Strong knowledge of FDA GCP-ICH Guidelines and local regulatory requirements
• Ability to travel up to 80% of the time (including frequent overnight/air travel)
• Ability to manage high workload and tight timelines
• Must be fluent in English

EDUCATION

• Bachelor’s Degree or equivalent; BA/BS in Life Sciences/Nursing preferred

Employer’s Rights

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. 509846