Lead Clinical Research Coordinator for Southeast Renal Research Institute

Transcription

1 Cindy Yancy- Spurgeon, BS, CCRC 45 East Main Street Chattanooga, TN (423) Lead Clinical Research Coordinator for Southeast Renal Research Institute EXPERIENCE: Aug 09-Present Southeast Renal Research Institute 45 East Main Street Chattanooga, TN Lead Clinical Research Coordinator Duties and Responsibilities: Managerial and Mentoring Responsibilities 1. Assist Research Department Manager and Medical Director with training of new research personnel. 2. Be available to new staff members for consultation and advice regarding patient eligibility, protocol logistics, GCP compliance, Policies & Procedures, etc. 3. Assist Research Department Manager and/or Medical Director in identifying areas of improvement, strengths and weaknesses, and training progress for new and continuing staff. 4. Evaluate protocols and access CRC time needed to conduct studies appropriately 5. Work with the Research Department Manager to properly allocate study assignments and re-assignments as needed 6. Assist with approving lab orders and appropriate expenses to the correct study when invoices are received 7. Mentor CRCs and additional staff as needed. 8. Assist other staff with problem solving issues with study implementation, protocol logistics, recruitment obstacles, etc. as needed. 9. Assist with training all new staff on Policies & Procedures in first 90 days of employment and other staff as needed with new policies or revisions. Study Management and Recruitment Oversight 1. Review and assess feasibility of new protocols, synopses, etc. Cindy Yancy Spurgeon CV- Version 16 April

2 2. Advise Medical Director on study loads and assignments for clinical research coordinators. 3. Assist other staff with problem solving issues with study implementation, protocol logistics, recruitment obstacles, etc. as needed. Quality Assurance Functions 1. Assist the Research Department Manager to Develop Quality Assurance (QA) program with assistance of Medical Director 2. Reinforce QA program to staff, modify as needed 3. Implement and help oversee QA program. 4. Report QA results to Research Department Manager on regular basis. Administrative Responsibilities 1. Work with Research Manager to maintain Policies & Procedures Manual. A. Assist with annual audit/update of manual. B. Evaluate on continuous basis need for new policies or revisions to current policies as FDA regulations or guidance changes. Assist with writing or revising these policies. Coordinate and Manage Clinical Studies: 1. Conduct all studies according to FDA regulations and guidelines. 2. Obtain detailed knowledge of all components of the study protocol through independent analysis and review to ensure completion of all study activities correctly and completely. 3. Cross-train all members of the research team to ensure an understanding and acceptance of roles and responsibilities for proper performance during the study. 4. Active involvement in planning of recruitment strategy. 5. Implementation of recruitment activities including phone screening of potential subjects, attendance at health and community fairs, distributing posters/flyers, etc. 6. Identify and screen potential study subjects accurately, on a timely basis, and within the recruitment period. 7. Schedule all subject visits and procedures to meet protocol requirements and timelines. This scheduling must be coordinated with investigators private practice offices and outpatient facilities. 8. Ensure that all protocol activities are performed by other research staff and the subject to meet protocol requirements. 9. Validate potential subject data against protocol-mandated inclusion/exclusion criteria to enroll qualified subjects only. 10. Ensure that all laboratory samples are collected properly and tests are performed at the designated laboratory facility accurately and on a timely basis. 11. Dispense study medication according to the protocol requirements and maintain accurate and complete distribution records. 12. Notify physician(s) of all potential adverse reactions to study medication. Distinguish between serious adverse events and non-emergent adverse events. Cindy Yancy Spurgeon CV- Version 16 April

3 13. Report all serious adverse events to the sponsor within 24 hours of becoming aware of the event and to the Institutional Review Board (IRB) according to its requirements. 14. Obtain and follow directions provided by the investigator(s) and ensure appropriate documentation of such orders. 15. Request and obtain medical records on every subject with release authorization on file. Record Keeping and Documentation: 1. Provide sponsor with accurate and complete documentation during scheduled monitoring visits. 2. Complete and maintain accurate, legible and thorough source documents per Nephrology Associates Research Standard Operating Procedures and FDA regulations. 3. Work to complete and maintain accurate, legible, and thorough case report forms according to Standard Operating Procedures and sponsor guidelines and requirements. 4. Ensure appropriate review and documentation by Principal Investigator of subject progress notes, lab results, regulatory documents, etc. 5. Archiving of subject records and other study related documents for long term retention 6. Maintaining accurate temperature logs of investigational products, storage room and specimen freezer. Subject Care: 1. Act as a subject advocate to ensure the safety and welfare of all subjects. 2. Explain to subjects, in layman s terms, the purpose, possible benefits, risks, etc. of participation in the study. This process of Informed Consent begins prior to the subject s participation and continues throughout the study on an ongoing basis. 3. Act as a liaison between the study subject and his/her physician concerning any problems, adverse reactions, etc. possibly related to the study medication or the study procedures. 4. Use judgment to analyze appropriate statistics and/or side effects for progress reports to the investigator(s). Report subject behaviour and adverse events on a timely basis to investigator(s). General Responsibilities: 1. Perform all required activities in the Policy and Procedure Manual with other research team members accurately, completely and in a timely manner. 2. Comply with all policies as specified in the Employee Policy Manual. 3. Work cooperatively and professionally with all staff and sponsor representatives to accomplish mutual goals. 4. Seek clarification of established policy prior to taking action which might deviate from standards set by local, state, federal and internal regulations or policies or from the study protocol Cindy Yancy Spurgeon CV- Version 16 April

4 Feb 06-Aug 09 Southeast Renal Research Institute, Clinical Research Coordinator Chattanooga, TN 1998-Jun 02 Southeastern Clinical Research, Clinical Research Coordinator Chattanooga, TN CERTIFICATIONS/LICENSES: March 2010 April 2003 November 2000 November 2000 November 2000 Re-Certification, Clinical Research Coordinator Re-certification, Clinical Research Coordinator Certified Clinical Research Coordinator (CCRC) Recertification, Certified Medical Assistant Recertification, Certified Phlebotomy Technician EDUCATION: 2010 Bachelor of Science in Business Management Bryan College, Dayton, Tennessee 1995 Academy of Allied Health Careers, Chattanooga, Tennessee, Medical Assistant Program; State Certified in 1996 CONTINUING EDUCATION: April 2003 February 2001 September 2000 Good Clinical Practice Conference, Chattanooga, Tennessee Good Clinical Practice Conference, Chattanooga, Tennessee Study Coordinator Workshop, Merck & Co., Inc. Cindy Yancy Spurgeon CV- Version 16 April

5 October 1998 Good Clinical Practice Training, ARC University, Gurnee, Illinois MEMBERSHIP(S): Society of Clinical Research Professional s (SOCRA) Association of Clinical Research Professionals (ACRP) THERAPUTIC EXPERIENCE: Gastroenterology Barrets Esophagus Colon Polyps Diabetic Gastroperisis Erosive Esophagitis Gastric Ulcer Acid Reflux IBS Dyspepsia Constipation Internal Medicine Community acquired Pneumonia COPD Erectile Dysfunction Gastric Ulcer Nephrology Renal Nephropathy CKD II, III CKD Anemia Hyperphospheternia Vitamin D Deficiency Diabetic Protienuria ESRD Anemia Renal Gout Home Hemodialysis Rheumatology RA Osteoarthritis Cindy Yancy Spurgeon CV- Version 16 April

6 Women s Health Endometriosis Hormone Replacement Therapy Polycystic Ovarian Syndrome Osteopenia Vulvaginal candisis Uterine polyps Cindy Yancy Spurgeon CV- Version 16 April