Clinical Lead (Snr Clinical Research Associate)

Location: work from home, FL
Job Type: Direct Hire
Salary: $1.00 - $1.00
Hourly: $1.00 - $2.00
Date: 3/6/2018
Job ID: 02568858
Job Description
Global Pharmaceutical company  (headquarted in West Palm BEach, Florida) is growing and needs a Strong Clinical Lead (someone who mas managed the CRAs and the clinical study trials but can also monitor when needed as Snr CRA).
Snr Clinical Research Associate for oncology trials. Must have five to eight years of experience with at least two years of oncology experience. Must come from a Sponsor company (Pharma or Biotech) and be bi-lingual (spanish speaking - many sites are in Latin America). Can work remotely form home but be willing to travel to and from sites (see travel information below)
This job includes base salary and generous benefits and long term incentives.
We are seeking an experienced Clinical Research Associate for pivotal phase 2/3 clinical studies. CRA will be  responsible for the execution of clinical trials through clinical monitoring. It requires attention to detail, focus, and strong relationship management skills.
The CRA will be interacting with a multifunctional team supporting in-house study execution and must have experience for at least 5 years in clinical trial execution.
Sites are located in the US and abroad (Asia, Europe, South America). Initially there will be 60-80% travel (as sites go through QA clean up) then travel will be limited to 25-30%.
Job Responsibilities:
  • Conduct Site Qualification, Initiation, and Interim Monitoring, Close-Out visits and activities in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)
  • Serve as primary site contact; establish and maintain regular communication with clinical sites
  • Train Investigators and site staff on protocol and study-specific processes
  • Assist with distribution, collection and tracking of essential regulatory documents for site compliance and audit readiness
  • Prepare and complete monitoring visit reports and letters, and effectively document site communications per the CMP
  • Review Informed Consent Forms (ICFs), completed Case Report Forms (CRFs), and other site documentation to verify subject protection, accurate data recording (source data verification), and adherence to the protocol and governing regulations
  • Identify and address routine site issues including protocol deviations and escalate to Study Lead (SL)
  • Review/complete quality control (QC) checks of Site Trial Master File (TMF)
  • Assist with the assembly of specimen collection kits
  • Assist with sample handling, shipment and receipt
  • Basic use of clinical databases and other associated data tracking tools
  • Assist in user acceptance testing of clinical study database(s)
  • Demonstrate basic proficiency of the Clinical Trial Management System (CTMS)
  • Recognize the need to escalate site issues/trends to SL when performing monitoring visits and provide necessary training to clinical trial sites
  • Study Start-up, Study Management
  • Intermediate proficiency of Clinical Trial Management System (CTMS)
Skills Needed:
  • General knowledge of clinical trial practices and regulations
  • General knowledge of clinical monitoring and trial design
  • Proficient use of clinical trial databases; Proficient knowledge of technical computer systems