CLINICAL RESEARCH ASSOCIATE II

Summary:

Under the direction of the Associate Director of Clinical Operations and the Clinical Trial Manager, the Clinical Research Associate II contributes to the tactical implementation and conduct of clinical research studies.  The CRA II ensures the quality of each research study through on-site centralized, and remote monitoring of protocol and regulatory compliance.  The CRA II represents Adela at the research site level and maintains collaborative relationships with investigator sites, any potential contract research organizations (CROs), and the internal clinical development team.

Responsibilities:

• Serves as liaison between Adela clinical development team and research site staff with respect to tactical elements of study completion
• Assesses site qualification potential (reviews study requirements and identifies sites through feasibility and qualification visits)
• Completes study start-up activities:
  • Assists with creation of study tools and training materials
  • Directs site staff through start-up activities
  • Assists with regulatory processes as needed
• Conducts on-site initiation, interim monitoring and close-out visits per Adela SOP to ensure data integrity and good clinical practice; writes and submits visit reports
• Conducts centralized monitoring tasks (remote data review for identification of queries, data trends, deviations, issue escalation, etc.)
• Verifies and fulfills site supply requests for product/study materials
• Tracks and escalates any safety events
• Drafts CAPA/intervention plans
• Communicates site enrollment and study metrics through maintenance of tracking tools
• Maintains trial master files for assigned clinical research projects
• Maintains professional expertise through familiarity with up-to-date medical and clinical operations knowledge and familiarity with Adela’s product pipeline.
• Works independently with minimal instruction and routine supervision by senior level CRA, CTM, or functional manager; may perform as CRA lead on studies as appointed by CRA Manager
• Field site travel up to 30%

Qualifications:

• Bachelor Degree: RN/BS/BA; scientific discipline preferred
• Minimum of 3+ years of Clinical Research Associate experience in diagnostics, pharmaceutical, medical device, or CRO setting
• Knowledge of medical terminology, clinical monitoring procedures (SOPs), and ICH/GCP guidelines
• Ability for attention to detail and accuracy in work
• Excellent written and oral communication skills
• Excellent organizational and time management skills
• Strong computer skills including Microsoft Office, EDC systems, eTMF