Core Competencies

Site Management

Site Research Coordinators are responsible for:

  • Managing clinical studies at the site
  • Supervising site personnel
  • Preparing specimens for shipment
  • Scheduling subject exams with investigators
  • Recruiting and enrolling study patients
  • Obtaining consent forms from patients in the clinical research trial
  • Maintaining all study files
  • Maintaining screening, enrollment and drug accountability logs
  • Managing overall coordination of clinical trials, data collection and data management
ALTERNA Site Research Coordinator Qualifications
  • 90% have a life science degree
  • More than 5 years of site management experience
  • Broad U.S. and Canadian talent pool
  • Extensive experience training sites and conducting feasibility assignments

Clinical Monitoring

Clinical Research Associate (CRA) duties include:

  • Performing all aspects of clinical monitoring, source documentation, and FDA and GCP compliance
  • Writing reports
  • Traveling to study sites
  • Determining site selection, initiation and close-out
  • Partnering with teams to successfully implement clinical trials and related activities
  • Managing the pre-study initiation process and other ongoing monitoring protocol needs
ALTERNA CRA Qualifications
  • 6.5 years of Regional CRA monitoring experience
  • 67% have a BSN degree, and 52% have site coordinating experience
  • Average working relationship with candidates is 3.5 years
  • More than 83% have EDC experience

Project Management

Project Managers are accountable for:

  • Managing the day-to-day operations and execution of protocols
  • Assisting with protocol writing and the development, creation and management of clinical trial budgets and resourcing plans
  • Ensuring trial adherence to ICH, GCP and local regulations
  • Planning, coordinating and tracking data management tasks for clinical studies
  • Developing and annotating CRFs and CRF Completion Guidelines
  • Developing, implementing and maintaining data management plans and databases
  • Providing status reports to department and project teams
ALTERNA Project Manager Qualifications
  • 60% have experience running global trials
  • Diverse candidate network of CRO, pharmaceutical, biotechnology and device experience
  • Average of more than 10 years of industry experience, including site management, monitoring and drug safety
  • Minimum of 3 years' direct experience with project and people management work
  • More than 78% have 2 or more therapeutic areas of expertise

Drug Safety

Drug Safety Associate responsibilities include:

  • Interacting with healthcare professionals and consumers to obtain and follow up on reports of possible adverse events (spontaneous/serious/non-serious), and entering the information into a database
  • Assisting with the preparation, compilation and submission of Adverse Event Reports to the FDA and other governmental agencies
  • Cleaning up data from SAE reports
  • Writing narratives
  • Completing consistency checks
  • Performing reconciliation from backlogs
ALTERNA Drug Safety Professional Qualifications
  • Diverse candidate network of CRO, pharmaceutical, biotechnology and device experience
  • 85% hold a life science degree, and 15% have a PhD
  • Average of more than 6 years of direct industry experience

Regulatory

Regulatory Affairs Associate duties include:

  • Performing project management activities associated with the compilation of client submissions to regulatory authorities, including paper and electronic formats
  • Reviewing clinical documentation, such as clinical study reports, protocols and informed consents
  • Providing regulatory guidance, training and support to staff, project teams and external clients
  • Developing and maintaining documentation of regulatory procedures to ensure consistent and compliant regulatory activities
ALTERNA Regulatory Affairs Associate Qualifications
  • Diverse candidate network of CRO, pharmaceutical, biotechnology and device experience
  • Average of more than 8 years of direct industry experience

Medical Writing

Medical/Scientific Writers are responsible for:

  • Researching, writing and editing clinical/statistical reports and study protocols
  • Summarizing data from clinical studies for submission to various governmental agencies or for publication and/or presentation
  • Resolving errors and inconsistencies in clinical data
  • Supporting clinical protocol development
ALTERNA Medical Writer Qualifications
  • Diverse candidate network of CRO, pharmaceutical, biotechnology and device experience
  • Average of more than 8 years of direct industry experience
  • Extensive direct experience in FDA submissions (NDA, NIH, IND)
  • Safety writing experience in support of drug development projects