Senior Clinical Research Associate - Regional Clinical Operations: Career Developers
| Job ID | KG101637 |
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| Company Name | Career Developers |
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| Job Category | Pharmaceutical/Biotech; Science/Research |
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| Location | Miami, FL |
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| Position Type | Full-Time, Employee |
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| Experience | 5-10 Years Experience |
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| Date Posted | October 29, 2009 (Reposted Nov 12) |
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| View Career Developers profile and job listings |
Senior Clinical Research Associate - Regional Clinical Operations
Employment agency specializing in Information Technology,
Life Sciences
and Finance recruiting, permanent and consulting
services.
Senior Clinical Research Associate - Regional Clinical Operations -
Miami FL
Base salary + Bonus + Car
-Completed BA/BS required, scientific concentrations preferred.
-8 years or more in pharma industry.
-At least 4 years (more is better) direct site monitoring experience.
-Strong plus would be bilingual English/Spanish skills.
-Monitor assigned investigative sites to ensure subject safety and timely high quality data in compliance with regulations.
Responsibilities :
1. Investigative Site Monitoring - conduct Pre-study , Study Initiation Visits, Interim Monitoring Visits at Investigative Sites; review investigator study files and reconcile versus trial master files; perform investigational product accountability; conduct Close-out Visits at Investigative Sites.
2. Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of subjects during participation in a study; evaluate data query trends and interact with study team to improve data quality; ensure issues of data quality are escalated and resolved with study team and CQA.
3.Perform safety reviews/SAE reconciliations; monitor informed consent process; eensure investigative sites' adherence to GCP, ICH guidelines, and local regulations.
4. Train and Assist Investigative Sites - Attend Investigator Meetings; train investigative site personnel in GCP and ensure sites are conducting clinical research according to the protocol, local regulatory requirements, etc.
5. Identify site issues and ensure resolution; create trip reports, confirmation/follow-up correspondence and telephone contacts for assigned sites; respond to audit findings; adhere to proper lines of communication within Company; attend and participate in study team meetings; keep information in the CTMS current; maintain calendar.
6. Maintain up-to-date medical and clinical knowledge for assigned therapeutic areas; mentor / coach new CRAs; maintain annual training records.
7. Identify/evaluate potential investigators for future studies; build effective and positive relationships with Principal Investigators; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; schedule travel according to policy, submit expense reports in an accurate and timely manner.
8. Regulatory Documentation - Prepare ethics submissions and local regulatory documents at the country level, as needed; maintain local document files at a country level, as needed; review translations for ICD and other study documents, as needed; oversee to assure SOPs are followed in obtaining translations on necessary study documents.
9. Monitoring Lead (As assigned) - Serve on study team as monitoring representative; review RFPs develop study monitoring plan and subsequent revisions; review, track and acknowledge monitoring visit reports; manage and track monitoring site visits ; ensure monitors are properly trained; track and report critical issues to study team; participate in CRF and protocol review process; attend, participate and present at Investigator Meetings; perform field assessments of Company and CRO FMs, as required; develop study-specific tools for Investigative sites and Field Monitors; conduct FM meetings; oversee CRO monitoring, as required.
Requirements:
-Significant medical and scientific knowledge
-Knowledge of investigational products under study
-Ability to comprehend protocols and supportive information
-Knowledge of Clinical Development Process
-Knowledge of regulatory environment and guidelines (ICH, GCP and CFR)
-Excellent written and oral communication skills, including presentations
-Excellent relationship-building skills
-Ability to work in a cross-functional team environment
-Ability to work independently
-Working knowledge of SOPs relevant to position
-Ability to drive an automobile and have a valid driver's license
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