Clinical Research Associate II (East, West, Central) - NCR

Novella Clinical Resourcing is seeking a CRA II or Sr CRA home based in the Western, Central, and Northeastern regions of the United States. This is a direct hire opportunity and includes competitive pay and benefits package along with annual bonus potential. Experience in Pulmonary, Cardiovascular, Oncology, or Pediatrics is a plus. Travel is 50-65%

Position Overview

The Clinical Research Associate II will work with the Clinical Operations staff and clinical research sites to facilitate study enrollment, confirm the accuracy of the study data, supervise the conduct of clinical trials, build effective site relationships and ensure sites are properly managed compliant with applicable registrations.

Key Accountabilities / Responsibilities

  • Serve as primary conduct for managing the relationship with assigned sites on behalf of Company, cultivating productive relationships and understanding local challenges and opportunities
  • Conduct site evaluation, initiation, monitoring and close out visits
  • Develop and implement study specific monitoring tools
  • Conduct clinical site initiation visits, advise and train site personnel on sponsor and regulatory requirements for study conduct.
  • Review on-site files and records, drug accountability, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provide remedial training and/or initiate corrective action as required
  • Collect, review and process regulatory documents and correspondence from participating trial sites
  • Track subject enrollment and participation at each trial site
  • Maintain tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution. This may include maintaining site information on Clinical Trial Management System (CTMS)
  • Provide site support for remote / electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
  • Perform termination of clinical studies through resolving final queries and completing closeout visits
  • Regularly meet with PIs at assigned sites to keep them apprised of issues/concerns affecting the study
  • Respond to site’s questions about EDC use
  • Gain a working knowledge of the diagnostic / therapeutic field and clinical trial material (CTM) that is to be studied
  • Provide support of CTM activities at site and study level. This may include study drug forecasting, assessing drug supply at clinical sites, reviewing and providing input on IVRS and drug accountability /reconciliation at clinical sites
  • Develop and implement recruitment plans to enhance site enrollment
  • Collaborate with CTL and CRA manager to respond to audit findings at the site level
  • Track personal finances for expense reporting and submission
  • Bachelor’s degree; preferably in health or biological sciences is required.
  • 6 years experience in Clinical Research with progressive experience working in clinical trials
  • CRA II level — 4 years experience as a Clinical Research Associate
  • Sr CRA level — 5 years experience as a Clinical Research Associate
  • Ability to travel minimum of 50% of the time

Preferred Knowledge, Skills, and Abilities

  • Proficient in Microsoft Office (Word, Excel, PowerPoint)
  • EDC and CTMS experience preferred
  • Knowledge of regulatory and clinical practices (GCP, ICH)
  • Must be able to demonstrate aptitude and knowledge in relevant therapeutic areas and/or ability to learn and integrate new/different therapeutic areas
  • Must be able to submit trip and expense reports in a timely manner
  • Must be detailed oriented, with strong time management and organization skills

EEO Minorities/Females/Protected Veterans/Disabled

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