Our Ability Jobs

Employer Name: Yale University

1. Serves as the primary oversight specialist on clinical and operational processes for low to moderately complex studies and non-therapeutic trials. Serves as a supporting clinical research coordinator to CRC/CRN II and Sr. CRC/CRN for highly complex protocols. 2. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for low to moderately complex studies and non-therapeutic trials. 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 for low to moderately complex clinical trials and non-therapeutic trials. 4. Ensures low to moderately complex study protocols are adhered to, oversees the maintenance of accurate documentation, recruitment of study participants and ensures 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 works with manager to analyze and advises noncompliance and deviations to the appropriate parties. 6. Advises Principal Investigator oversight on low to moderately complex clinical trials and non-therapeutic trials by providing 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 on low to moderately complex clinical trials and non-therapeutic trials. Coordinates 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 on low to moderately complex clinical trials and non-therapeutic trials. 9. Assesses trial execution for assigned low to moderately complex trials and non-therapeutic trials 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 and ensures implementation and adherence to stated plan for low to moderately complex trials and non-therapeutic trials. 11. Collaborates with the Quality Education Unit to contribute to the design of CRC trainings and continuing education. 12. Participates in interim monitoring visits and internal audits. 13. Monitors, interprets, and communicates federal and state regulations, and local policies for new guidance, updates, or policies. 14. Performs other duties as assigned. Required Skill/ability 1: Demonstrated excellent organizational ability and time management skills. Ability to meet deadlines within a high-volume environment. Required Skill/ability 2: Strong communication skills, the ability to communicate effectively and diplomatically in written and verbal forms with internal and external contacts, patients, faculty, and staff. Required Skill/ability 3: Superior computer skills including proficiency in Microsoft Word, Outlook, Excel, and PowerPoint. Proven ability to design spreadsheets and graphics and willingness to learn new technologies. Required Skill/ability 4: Well-developed interpersonal skills and ability to form strong working relationships with faculty, staff, patients, and other stakeholders. Ability to take ownership of providing superior customer services. Required Skill/ability 5: Well-developed problem-solving skills. Proficient in framing an issue, identifying and evaluating potential solutions, and seeing issue through to resolution. Preferred Education: Proven experience working with confidential information and coordinating patient studies. Special skills desired include ability to be flexible with change and to function at a high level of organization and prioritization combined with strong attention to detail and accuracy. Ability to problem solve and work independently with minimal supervision. Work Week: Standard (M-F equal number of hours per day) Posting Position Title: Clinical Research Coordinator 1 University Job Title: Clinical Research Coordinator Preferred Education, Experience and Skills: Proven experience working with confidential information and coordinating patient studies. Special skills desired include ability to be flexible with change and to function at a high level of organization and prioritization combined with strong attention to detail and accuracy. Ability to problem solve and work independently with minimal supervision. Bachelor's degree in a health-related discipline, or other related field and one (1) year of clinical research experience, or the equivalent combination of education or experience. 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.