Iris Hindle Email & Phone Number

Raleigh-Durham, North Carolina Area

Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and/or IV clinical trials research projects conducted by principal investigator(s) at Duke Clinical Research Institute (DCRI); perform a variety of duties involved in the organization, documentation and compilation of clinical research data.Follow established guidelines in the collection of clinical data and administration of clinical trials; assist in the determination guidelines for new protocols. Assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies, contribute to the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate. Confer with site coordinators and physicians to explain protocol and elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate. Coordinate and lead the work of the research team and provide feedback to staff supervision on a routine basis. Participate in conjunction with the principal investigator in the final negotiations of trial budget and contract. Prepare a variety of narrative and analytical reports, documents, and correspondence for contracting agencies, team members, participating departments and senior management regarding trial status; recommend corrective action as necessary.

Raleigh-Durham, North Carolina Area

Manage the development, coordination and implementation of clinical operations, site management and clinical monitoring responsibilities for assigned projects with guidance including trial-specific processes and systems, and daily supervision of the Clinical Operations team responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs and applicable international federal and state regulations, and ICH guidelines.

Raleigh-Durham, North Carolina Area

Managed the daily tasks of 20 Clinical Research Associates with various experience levels. 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 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 are or may lead contribute to initiatives that enhance department and business objectives.

Raleigh-Durham, North Carolina Area

Managed day to day activities of a clinical projectDuties of a Senior Clinical Trial Manager include communicating regularly with study team, regarding issued such as protocol, subject participation, case report form completion, and other study related issues. Participated in data listing reviews, vendor selection and management. Also managed study related activities such as CRF design, paper and electronic, collection, query resolution, 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. Conducted CRA performance appraisals and provided input for merit adjustments and bonuses. Conducted and completed a through QC of the project files, provided weekly comprehensive metrics to the Sponsors, participated in Sponsor meetings, internal meetings, proficiently review data listings to ensure a timely database lock.

Raleigh-Durham, North Carolina Area

Coordinating day to day activities of the clinical team on projectsDuties of a Clinical Team Manager include managing a team of CRA with a variety of experience levels, ensuring their compliance with company and client requirements and oversight of the quality and timeliness of the CRA’s work. Base on study needs the Clinical Team Manager will perform the duties of a CRA with added responsibility of mentoring, managing, and provided formal reviews of CRA team. The Clinical Team Manager 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.

Raleigh-Durham, North Carolina Area

Perform duties of Clinical Research Associate as well as assisting with manager duties such as review trip reports, update trackers and prepare newsletters.Responsible for monitoring and management of approximately 5-6 Investigational sites. Performed Interim Monitoring and Close Out visits according to client company Standard Operational 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.

Raleigh-Durham, North Carolina Area

Conduct site visits to ensure compliance with protocol and FDA guidelinesResponsible for the monitoring and management of 10 investigational sites participating in studies. Assisted in recruitment of Investigational sites, preformed 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. Performed drug accountability and reported adverse events promptly, collected and reviewed essential regulatory documents and assisted sites in preparation for Sponsor audits.

Raleigh-Durham, North Carolina Area

Coordinate multiple clinical trialsResponsibilities included coordinating clinical trials in the areas of pulmonary, women’s health, chronic pain, osteoarthritis and pediatric, recruited potential participants for the above mention clinical trials, maintained regulatory files and designed start-up tools, CP guidelines as well as department Standard Operation Procedures, interacted with monitors from various pharmaceutical companies and designed recruitment advertising and flyers for IRB approval.

Bachelor'S Degree, Psychology, 3.0

Bachelor'S Degree, Public Health Education

Associate Of Science (A.S.), Radiology Science