Senior Clinical Research Associate
Company: ExecuPharm
Location: Los Angeles
Posted on: January 27, 2023
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Job Description:
ExecuPharm is looking for a Senior CRA's nationwide!!!Position
Purpose: The Senior Field Clinical Research Associate (fSrCRA) is
responsible for field monitoring and management of clinical sites.
This position focuses on all activities required to evaluate,
initiate, monitor and close clinical sites in compliance with the
Code of Federal Regulations and ICHGCP Guidelines. This role may
provide operational input to clinical study teams as anizational
Relationships: Reports to ExecuPharm Line Manager with day-to-day
direction from the Client.Liaises with cross functional lines as
appropriate.Primary Duties: Act as liaison between the in-house
team, vendors, and multiple clinical sites.Work collaboratively
with investigative sites to develop strong, long-term, working
relationships.Apply SOPs, Clinical Monitoring Plan (CMP), study
manuals and other materials and guidelines as applicable.Help
identify and qualify potential investigators. Perform Pre-Study
Site Visits.Assist with start-up activities, including essential
document review and collection as requested.Perform Site Initiation
Visits.Provide initial and ongoing training to site personnel
regarding the study protocol, applicable policiesprocedures, and
GCP.Perform Interim Monitoring Visits for assigned studies:Monitor
site compliance with study protocol, and GCP.Perform source data
review and verify adequacy of clinical data through comparison of
case report forms to source documents per CMP.Ensure the site is
entering data according to the Case Report Forms (CRF) Completion
Guidelines and meeting data entry and query resolution
deadlines.Perform drug accountability and ensure adequate drug
supply.Review research specimen sample documentation, storage and
processing and ensure shipments are sent to central lab as
required. Assist study team as necessary in resolving lab queries
and other issues.Collaborate with the drug safety group to ensure
site compliance with serious adverse event reporting
requirements.Ensure adequacy of clinical supplies to the
site.Collect and review site essential documents and ensure site
regulatory file is complete and accurate.Monitor site compliance
with IRB policiesprocesses and ensure timely submissions and
approvals.Track and report progress of study, data monitoring,
protocol variations, issue resolution, and follow up
compliance.Ensure site staff is appropriately trained, and site
responsibilities are delegated to qualified staff.Perform Close Out
visits as assigned.Prepare and submit visit trip reports,
confirmation and follow up letters within timelines outlined in the
CMP.Track, report, and follow all action items to
resolution.Maintain Clinical Trial Management (CTMS) in a timely
fashion, utilizing available reports and study tools.Work
proactively with sites to address site issues and action items to
obtain swift resolution and escalate to Clientsite per CMP.Assist
data management as required.Provide co-monitoring support as
requested.Contribute to the preparation and follow-up of on-site
sponsored quality audits and regulatory authority inspections as
assigned.Complete routine administrative tasks in a timely
manner.Discuss scientific, medical and therapeutic area
information.Adhere to CFR, GCPICH, company policies, Clinical
Operations and project specific quality documents (e.g. SOPs, work
practices, training guides).Attend staff meetings and trainings as
required.May have opportunities to contribute to other clinical
trial related activities, including vendor management, data review,
or other study-related activities.Contribute to department
initiatives.May contribute to development and revision of study
specific Clinical Monitoring Plans and CRF Completion Guidelines
and other study documents.May serve as a Subject Matter Expert
(SME).Completes training assigned by Client andor EP, as necessary,
including general training requirements, SOPs, and system and
process related trainingAdheres to EP and Client SOPs and
processesSkills and Education:BABS, or equivalent, or relevant
experience and training with at least 3 years of
pharmaceuticalbiotech experience. RN or health care professional
preferred.Prior monitoring experience is required.
Oncologyhematology clinical trial experience is preferred. FDAEMA
inspection experience is preferred.Proficiency in CFR and GCPICH
Guidelines is required. Experience working on global clinical
trials is preferred.Proficiency in Microsoft Office Products (Word,
Excel, PowerPoint, SharePoint) and other electronic systems (CTMS,
EDC and eTMF).Excellent communication and organizational
skills.
Keywords: ExecuPharm, Los Angeles , Senior Clinical Research Associate, Other , Los Angeles, California
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