Research Associate II, Clinical Trials (Durational with Benefits)

Job Summary:

Coordinates day-to-day activities of several small scale project(s) or phases of one or more larger projects. May oversee assigned work of project staff. Works under general supervision. Final review required for each phase of project.

Essential Responsibilities:

• Coordinates day-to-day activities of several small scale project(s) or phases of one or more larger projects. Collects project data through interviews, chart review or other methods. May collect, secure and assist with biospecimen management.
• May assist in development of study tools (e.g. tracking forms, questionnaires, chart review forms, etc.).
• Assists with and/ or oversees assigned study activities (e.g. data collection and validation, recruitment activities, pilot studies, focus groups, etc).
• Drafts project progress reports collaboratively.
• May participate in the training of new team members and/or clinical staff. If assigned to clinical trial, may work with Sponsors/ monitors at clinical sites.
• Adheres to compliance and privacy/ confidentiality requirements and standards. Adheres to GCP and compliance regulations for clinical trials.
• Assists with and/ or oversees quality assurance of study activities; ensures quality data.
• Acquires and maintains knowledge of KP systems and databases.
• Identifies, recommends and implements solutions to study issues.
• May interface with IRB and/ or draft portions of IRB protocols, amendments, continuing reviews, etc.
• May supervise the day-to-day activities of project staff (ex. assign work and evaluate performance, etc).
• May assist with staff hiring and training.
• May contribute to portions of study presentations.
• Serves as a member on department or study-related committees.
• May track expenses and monitor budget. May recommend budget actions/ decisions.
• May provide information and oversight for invoices.
• Reviews scientific literature and synthesizes and summarizes information.