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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research
Industries
Biotechnology Research
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