1.Serves as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols. 2. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration. 3.Contributes to study feasibility reviews and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes. 4.Ensures study protocols are adhered to, oversees the maintenance of accurate documentation, recruitment of study participants and regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. 5.Identifies instances of noncompliance and deviations from protocol and reports and advises noncompliance and deviations to the appropriate parties. 6.Advises Principal Investigator through updates on protocol issues, status of signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required. 7.Analyses, documents and conveys study data. Collaborates with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner. 8.Oversees the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations. 9.Assesses trial execution program wide and identifies areas that need improvement or that require correction and provides education and/or recommendations, as needed. 10.Collaborates with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans in the preparation of corrective action plans and ensures implementation and adherence to stated plan. 11.Collaborates with the Quality Education Unit to contribute to the design of CRC trainings and continuing education 12.Participates in interim monitoring visits, internal audits, and external audits/inspections. 13.Oversees the work and advises on protocol management and recruitment to CRC I development. 14.Monitors, interprets, and communicates federal and state regulations, and local policies for new guidance, updates, or policies. 15. Performs other duties as assigned.
Required Skill/ability 1: Professionalism, good judgment, and ability to work with confidential material and protected health information. Advanced interpersonal, oral, and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.
Required Skill/ability 2: Self-directed with the ability to work, plan, research, and manage multiple studies with minimal supervision, on a flexible schedule, and with best practice expertise.
Required Skill/ability 3: Advanced ability to manage multiple/diverse studies simultaneously. Proven ability to multi-task and remain focused in a fast-paced environment.
Required Skill/ability 4: Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, applicable federal regulations, and institutional practices, standards, policies, and procedures at the unit/functional level. Strong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).
Required Skill/ability 5: Ability to be analytical in nature and assignments range from moderately complex to complex to co-support planning. Decisions are guided by clear to obscure guidelines and policies and can have a moderate short-term impact to the areas of which they are accountable.
Preferred Education: Knowledge of clinical trial management systems. Demonstrated experience documenting in an Electronic Medical Record (EMR). Oncology experience.
Work Week: Standard (M-F equal number of hours per day)
Posting Position Title: Clinical Research Coordinator 2
University Job Title: Clinical Research Coordinator 2
Preferred Education, Experience and Skills: Knowledge of clinical trial management systems. Demonstrated experience documenting in an Electronic Medical Record (EMR). Oncology experience. Bachelor's degree in a health-related discipline, or other related field and two (2) years of demonstrated clinical research experience, or the equivalent combination of education or demonstrated experience.Minimum of one (1) year experience in clinical trials coordination.Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required. Experience must indicate the ability to work with minimal supervision in a team environment.
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