Field CRA II - Northeast, US

Field Based
Mar 20, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Field CRA 2 is responsible for monitoring and management of clinical sites.  This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines.


  • Act as liaison between the in-house team, vendors, and multiple clinical sites
  • Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits
  • Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials as applicable
  • Help identify and qualify potential investigators.  Perform Pre-Study Site Visits
  • Assist with start-up activities, including essential document review and collection as requested
  • Perform Site Initiation Visits
  • Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements
  • Perform Interim Monitoring Visits for assigned studies:
    • Monitor site compliance with study protocol and GCP
    • Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP
    • Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines
    • Perform drug accountability and ensure adequate drug supply
    • Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required
    • Assist study team as necessary in resolving lab queries and other issues
  • Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements
  • Ensure adequacy of clinical supplies to the site
  • Collect and review site essential documents and ensure site regulatory files are complete and accurate
  • Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals
  • Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance
  • Ensure site staff is appropriately trained and site responsibilities are delegated to qualified staff
  • Perform Close Out visits as assigned
  • Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP
  • Track, report, and follow all action items to resolution
  • Maintain CTMS in a timely fashion, utilizing available reports and study tools
  • Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP
  • Assist data management as required
  • Provide co-monitoring support as requested or as necessary to develop additional skills
  • May assist in the preparation and follow-up of on-site Seattle Genetics sponsored quality audits and regulatory authority inspections as assigned
  • Complete routine administrative tasks in a timely manner
  • Demonstrate increased ability to discuss scientific, medical and therapeutic area information
  • Attend staff meetings and trainings as required
  • May have opportunities to contribute to other clinical trial related activities, including vendor management, data review, essential document review, or other study-related activities
  • Adhere to the Code of Federal Regulation, GCP/ICH, Seattle Genetics’, INC. policies, department and project specific requirements (e.g. SOPs, work practices, training guides). Expected to continue to expand CFR, GCP/ICH knowledge


  • BA/BS, or equivalent, or a minimum of 4 years of other relevant experience and training.  Prior oncology is preferred.  Prior monitoring experience is required
  • Knowledge of and ability to apply CFR and GCP/ICH is required Experience on global clinical trials is preferred
  • Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred) Previous experience with EDC and CTMS systems
  • Requires effective organizational and time management skills
    • Able to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative. Ability to prioritize workload with attention to detail
  •  Strong communication and interpersonal skills
  • Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals
  • Flexibility towards work assignments, learning, and travel
  • Able and willing to travel 60-80%. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location
  • Responsive and proactive, a team player 

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.