Senior Clinical Research Associate

Job Type: Remote – Location: United States (Remote) – Salary: $85,000 – $120,000/ year

Job Summary:

The Senior Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.

ESSENTIAL DUTIES:
  • Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out
  • Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
  • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
  • Monitoring and documenting investigational product dispensing, inventory, and reconciliation
  • Monitoring and documenting laboratory sample storage and shipment
  • Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
  • Reviewing data queries and listings, and working with the study centers to resolve data discrepancies
  • Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues
  • Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present
  • Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
  • Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs
OTHER QUALIFICATIONS:
  • Detail oriented
  • Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
  • Flexibility with changing priorities
  • Ability to efficiently perform and prioritize multiple tasks
  • Familiarity with medical and pharmaceutical industry, and related terminology and practices
  • Extensive knowledge of FDA regulations and their practical implementation
  • Ability to travel, including by air or by car on short notice
  • A valid driver’s license with access to a car with up-to-date car insuranceComputer proficiency in Microsoft Word, Excel, and PowerPoint
EDUCATION AND/OR EXPERIENCE:
  • Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
  • 7 years of prior experience as a Clinical Research Associate preferred
PERKS AND BENEFITS:
  • Competitive pay
  • Career growth
  • Full medical, dental, and vision benefit packages
  • 401(k)
  • Commuter benefits
  • Legal benefits
  • The best coworkers, if we do say so ourselves

Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.

Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact HR@ntdstaffing.com.

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