Iris Hindle Email & Phone Number

Managed the daily tasks of 20 Clinical Research Associates with various experiences. Developed and presented training on a monthly basis, and provided upper management with monthly performance metrics for my direct reports.Duties of a Clinical Manager-Clinical Research Associates include responsibilities for line management of the CRAs, selection, training, coaching and performance management of CRAs. Focus on end results to be achieved, uses metrics and key performance indicators to manage individual and team performance. May lead the Clinical Management team for a country or geographical area or may lead contribute to initiatives that enhance department and business objectives.

Duties of a Senior Clinical Team Manager include communicating regularly with study team, regarding issues such as protocol, subject participation, case report form completion, and other study related issues participated in data listing review, vendor selection and management. Also managed study related activities including CRF design, paper and electronic, collection, query resolution, CRF safety review, investigator training and site management to ensure contractual obligations were met. Conducted a comprehensive and timely review of trip reports, follow up letters and phone contact reports to ensure accuracy and completion. Communicated regularly with the Sponsor regarding study related issues. Conducted CRA performance appraisals and provided input for merit adjustments and bonuses. Conducted and complete a through QC of the project file, provided weekly comprehensive metrics to the sponsor, participant in Sponsor meetings and internal meetings, proficiently reviewed data listings to ensure a timely database lock.

Duties of a Clinical Team Manager included managing a team of Clinical Research Associates with a variety of experience bases, ensuring their compliance with company and client requirements and oversight of the quality and timeliness of the Clinical Research Associates' work. Based on study need, Clinical Team Manager will perform the duties of a Clinical Research Associates with the added responsibility of mentoring, managing and provided formal reviews of the Clinical Research Associate team. The Clinical Team Management has project management responsibilities including strategizing to meet study deliverable timelines and keep the team on target by working to resolve personnel and project issues proactively.

Responsible for monitoring and management of approximately 5-6 Investigational sites. Perform Interim Monitoring and Close Out Visits according to client company Standard Operation Procedures and FDA guidelines. Review case report forms for completeness, clarity, legibility, conformity to available source documentation and adherence for protocol requirements. Resolve CRF discrepancies and/or clarification via site visit, telephone or fax as deemed appropriate for the study.

Responsible for the monitoring and management of 10 investigational sites participating in studies. Assisted in recruitment of Investigator sites. Perform Pre-Study, Initiation, Interim Monitoring and Close Out Visits according to applicable Standard Operating Procedures and FDA guidelines. Review Case Report Forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements. Resolve CRF discrepancies and/or clarifications via site visit, telephone or fax as deemed appropriate for the study. Perform drug accountability and reported adverse events promptly, collected and review essential regulatory documents and assisted sites in preparations for Sponsor audits

Responsibilities included coordinator clinical trials in the areas of pulmonary, women's health, chronic pain and osteoarthritis, recruited potential participants for the above mentioned clinical trials, maintained regulatory files and designed start-up tools CP guidelines as well as departmental Standard Operation Procedures, interacted with monitors from various pharmaceutical companies and designed recruitment advertising and flyers for IRB approvals.