Senior Clinical Research Associate (Remote)
Company: Bracane company
Location: Plano
Posted on: January 25, 2023
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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
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