Senior Clinical Research Associate

Overview

Senior Clinical Research Associate - Fixed Term

Location:

United States

Workplace Type:
Remote

This is a 6 month fixed-term position with the option to renew or hire full-time.

• Conduct monitoring activities at assigned clinical trial site(s).
• Verify the adequacy, reliability, and quality of data collected at clinical sites.
• Ensure the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and applicable regulatory requirements in the assigned countries.
• Safeguard subject safety, data integrity, and subject confidentiality.
• Mentor CRAs and other Clinical Operations staff.
• Anticipate, recognize and resolve issues at the served study sites and may oversee such activities of CRA/other CO staff.

• Follows and ensures assigned studies are conducted in compliance with the currently approved Protocol(s)/Amendment(s), SOPs, CFR, GCP, and local or country regulations.
• Participates in Investigator feasibility and site selection by contacting sites to obtain feasibility information.
• Conducts site qualification (pre-study), site initiation, routine interim and close-monitoring visits for assigned studies and sites.
• Travels to research sites to conduct on-site visits as required.
• Prepares site submissions to Independent Ethics Committees and Competent/Regulatory Authorities when applicable.
• Assists with development of Investigator and Institution contracts and budget templates; negotiates site budgets and arranges site payments when applicable.
• Attends internal CRA team meetings and participates in study team and sponsor meetings as required.
• Participates in Investigator meetings and assists with meeting preparation when required.
• Conducts monitoring visits per the Monitoring Plan or as instructed by the study team and confirms visit attendance with site staff.
• Manages own monitoring visit schedule for all assigned sites in accordance with the Monitoring Plan or study needs.
• Proactively schedules appointments to meet with site staff during monitoring visits.
• Verifies that delegated study staff at assigned sites are trained/certified and maintain compliance with requirements of the study protocol, informed consent, data collection, IP/IMP accountability, and safety reporting.
• Ensures adequacy, reliability, and quality of all study data at assigned sites by performing source data review, source document verification, query resolution, and regulatory document and IP review.
• Ensures each assigned site is equipped with necessary study equipment and supplies, and that procedures (including sampling, processing, storage and shipment logistics) are adhered to.
• Ensures subject safety, data integrity, and subject confidentiality.
• Writes monitoring visit reports (MVRs) and sends site visit follow-up letters (FUL) as outlined in SOPs and study Monitoring Plans.
• Routinely reviews the Investigator Site File (ISF) and the Pharmacy Binder for accuracy, timeliness, and completeness.
• Reconciles the ISF with the TMF and uploads documents obtained during monitoring visits to the TMF to ensure inspection readiness.
• Maintains awareness of key study performance indicators via regular communication with site and study team members.
• Discusses study status, timelines, patient recruitment, screening, enrollment, and retention efforts, ongoing patient status, IP/IMP supplies, and study needs with each assigned site.
• Conducts routine follow-up of open action items between monitoring visits to ensure timely closure.
• Creates and maintains study/site trackers to successfully conduct monitoring visits.
• Provides project-specific training, mentoring, and/or co-monitoring with new CRAs.
• Completes assigned function area and study-specific trainings.
• Performs other duties as assigned per Advanced Clinical needs.

• Must have 3-5 years of clinical monitoring experience.
• Bachelor's degree in life sciences, nursing, or equivalent experience.
• Ability to travel up to an average of 80%, depending on project needs.
• Clear understanding of the drug development process, clinical monitoring, and safety and regulatory requirements.
• Excellent verbal and written communications skills, with strong interpersonal, presentation, and organizational skills and attention to detail.
• Ability to work independently and in a team environment.
• Computer literate with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• This role may be office- and/or home-based; regular infrequent visits to a Company office may be required.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research by approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues…