Senior Clinical Research Associate (Remote)

Company: Bracane company
Location: Plano
Posted on: January 25, 2023

Job Description:

Clinical Research Associate (CRA) - Senior / PrincipalJOB DESCRIPTION: Monitors progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start-up, enrollment, follow- up and closure of clinical trial activities.KEY RESPONSIBILITIES---Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate, and resolve data discrepancies.---Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence. Thorough documentation and proper escalation of issues are essential in all visit reports.---Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification, and training records.---Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented, and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required.---Event Reporting: ensures that all reportable events are identified, clearly documented, and reported per protocol and as per applicable requirements and regulations.---Collaboration: participates in study-specific meetings, teleconferences, and trainings. Collaborates with cross-functional team members and study sites throughout all study phases.---Documentation: Manages study contracts, request/collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator/site documentation, review and approval of subset of documents in the applicable database. Performs budget negotiations.QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES:Build Quality into all aspects of their work by maintaining compliance with all quality requirements. Integrity in the work that they do and produce a high quality of work.REQUIRED Experience/Skills/Education necessary to do the job:---Minimum five (5) years of continuous independent onsite monitoring experience as a CRA.---Ability to independently oversee sites and handle not only monitoring responsibility but also oversee site management activities (i.e., regulatory document collection, assigning site staff training, informed consent review, assisting site with IRB submissions, and all other required activities).---Successfully manage a high volume of monitoring and site management activities with a high level of detail and follow-up---BS/BA required---Travel: need to be able to travel approximately 70%---Work Location: the US Only. Home Based. Must be within an hour of a major Airport.Interview Process includes a background check

Keywords: Bracane company, Plano , Senior Clinical Research Associate (Remote), Other , Plano, Texas