Clinical Operations Manager- Urology

Clinical Research Manager

Manages all activities associated with highly complex clinical research studies. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks / deliverables to ensure timelines, milestones & / or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. Creates and nurtures collaborations and partnerships with outside affiliate institutions, clinical research organizations, and pharmaceutical partners. Provides feasibility input and accrual monitoring to support investigators in study planning and execution. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).

Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and / or far-reaching implications.

Specific Responsibilities

Program Development :

• Assists with determining goals, objectives, outcome measurements and metrics, financial feasibility, and collaboration opportunities as it relates to clinical research with other internal and external organizations. Implements policies, procedures, and training for partners.
• Directs actions to ensure high quality clinical research standards are maintained across all partner programs.
• Recruit, hire, train, and supervise clinical research staff across partner programs.

Technical :

Administrative :

Finance :

Supervision / Training Activities :

Miscellaneous :

Performs other duties as assigned.

Minimum Qualifications

Minimum Competencies : (Skills, knowledge, and abilities.)