Clinical Research Floor Staff
Resume:
ANDREW D. ATALIG, CCRP
Henderson, NV 89074
*******@*****.***
CLINICAL RESEARCH PROFESSIONAL
SUMMARY
Successfully accumulated over 12 years of clinical research study trials experience and management of all administrative aspects of clinical trials within the guidelines of GCP, ICH, HIPAA and FDA regulations. My clinical laboratory background and research study management has enhanced my ability to review sponsor protocols, case report forms, and source documents for both drug (IND) and device (IDE) study trials. Therapeutic area includes: vaccines, oncology, nephrology, endocrinology, pediatric rheumatology, allergy, CNS, cardiovascular, dermatology and antibiotics. Certified as a clinical research professional through the Society of Clinical Research Associates. Currently employed as a Clinical Research Associate with ICON assigned to Sanofi
(vaccines) traveling to investigator sites both domestic and abroad monitoring start-up regulatory submissions, pre-site selection, site-initiation, study conduct, electronic data capture (EDC) entries through study closing visits. Technical knowledge includes:
• Monitor’s Phase I, II, III, and IV Clinical trials
• Performance evaluations of direct reports
• Medical Laboratory and Pharmacy Technician
• Primary contact for Sponsors, IRB, and vendors
• Staff supervision and training
• Phlebotomy, EKG’s, and Vitals
• GCP, NIH, IATA, CPR certified
• SOCRA certified as CCRP
PROFESSIONAL EXPERIENCE
PRA/ICON
Clinical Functional Service Partnerships (Merck & Sanofi) Regionally based in Las Vegas, NV Dec. 2020 – Present Clinical Research Associate II
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines.
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
• Performs essential document site file reconciliation.
• Escalates site and trial related issues per ICON SOP's until identified issues are resolved or closed.
• Completes monitoring activity documents required by ICON SOP's or other contractual obligations.
• Provides regular site status information to team members, trial management, and updates trial management tools.
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely.
• Assess IP accountability, dispensation, and compliance at the investigative sites.
• Performs source document verification and query resolution.
• Verifies Serious Adverse Event reporting according to trial specifications and ICH-GCP guidelines.
• Communicates with investigative sites and facilitates audits and audit resolution. ANDREW D. ATALIG, CCRP Page 2
IQVIA
Clinical Functional Service Partnerships (Roche)
Regionally based in Las Vegas, NV Nov. 2018 – Dec. 2020 Clinical Research Associate I
Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. Accountable for development of project subject recruitment plan on a per site basis. Supported sites in order to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. Therapeutic areas in Alzheimer’s Disease, Age related Macular Degeneration, Pediatric Anemia in CKD. This includes:
• Providing monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administering protocol and related study training to assigned sites and establishing regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adhering to applicable regulations. Escalating quality issues as appropriate.
• Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Supported start-up phase.
• Creating and maintaining appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and generating follow-up letters. University of Southern California
Keck School of Medicine
Alzheimer’s Therapeutic Research Institute, San Diego, CA May 2016 – Oct. 2018 Clinical Monitor
Conducted monitoring activities at several clinical sites throughout the U.S. for clinical drug trials in Alzheimer’s Disease. Provided specialized research support to investigators in the development of research protocols for a project or study. Supervised a segment of a research project such as data collection or data analysis. This includes:
• Assisting in the design of study protocols; recommending methods and procedures for data acquisition, management and quality control, statistical techniques for data analysis and contributing to the writing of reports, research papers, articles and other documentation of study results.
• Assisting in building and maintaining study samples and disseminated information about the project. Screening participants by assessing eligibility for research protocols and potential for commitment to project.
• Monitoring participant progression throughout study and conducting evaluation at end of study. Contributing to the documentation and update of study procedures. Coordinating design, revision, approval and production of research instruments and related materials such as consent forms.
• Instructing study personnel on proper protocol and quality assurance procedures and responding to questions regarding data collection, coding, management and analysis methods.
• Conducting quality assurance reviews of research protocols. Monitoring and citing violations and submitting regular monitor visit reports and post visit letters. ANDREW D. ATALIG, CCRP
Page 3
National Institute of Clinical Research, Los Angeles, CA Mar. 2012 – May 2016 Sr. Clinical Research Coordinator/ Site Manager
Responsible for the administration and coordination of clinical trials involving new or improved regimens for institutional and industry-sponsored studies in assurance with ICH, GCP guidelines and Code of Federal Regulations. This includes:
• Ensuring compliance with NICR, industry and Federal regulations and responsible for all clinical research regulatory documents required by various committees, (i.e., FDA, Biosafety Committee, General Clinical Research Center).
• Ensuring that the execution of all clinical trials complies with Federal regulations on human subjects research.
• Collecting demographic information, information regarding vital signs, stage of disease, and previous treatments and verifying patient history and medical information required to meet entry criteria for enrollment into clinical trials.
• Submitting required data and CRF’s to statistical centers and assisting with coding and submissions of adverse events data.
• Designing and/or using source documents and flow sheets that help assure patient compliance to protocol requirements.
• Maintaining accurate records and research charts.
• Preparing for Quality Assurance audits by the drug company, sponsor and/or the FDA. West Coast Clinical Trials, LLC, Cypress, CA May 2010 – Oct. 2011 Clinical Research Coordinator
Coordinated Phase I drug trials with enrollment of about 2 to 12 subjects for special population studies and up to 120 subjects for healthy volunteer studies. Responsible for directing study start-up by participating in pre-study visits and initiation visits. Oversee study operations; observe PK collection days to ensure all procedures, dosing and other study procedures are being completed per protocol. Therapeutics included allergies, diabetes, ethnic bridging studies, and special populations. This includes:
• Reviewing source documentation developed by clinical support staff and ensures adherence to protocol. Monitoring overall recruitment efforts and directs plans to reach enrollment goals.
• Reviewing Inclusion / Exclusion criteria and source documents for all screening visits conducted. Ensuring that visits are done correctly, with minimal errors. Reviewing source books and case report forms prior to monitoring visits.
• Performing audits, including study-related logs (drug log, consent log, etc.). Conducting and documenting staff training as needed. Developing and updating Unit Rules and Guidelines. Ensuring that Site SOP’s are being followed and updating and/or developing SOP’s as necessary.
• Providing team oversight by conducting weekly team meetings. Assessing overall study status and providing updates on all ongoing Phase I studies to the team leader.
• Mentoring and providing performance feedback on clinical research support staff and research assistants. Providing support for team needs.
ANDREW D. ATALIG, CCRP Page 4
Profil Institute for Clinical Research, Inc., Chula Vista, CA Aug. 2008 – Sep. 2009 Clinical Project Manager
Managed Phase I diabetes studies in a clinical site. Completed 2 drug trials and 1 device trial from site initiation through study close-out with enrollment of 8-12 subjects for the drug trials and about 60 subjects for the device study. Attended all site selection, site initiation, interim monitoring, and close-out visits for each study assigned to me. Responsible for the management of sponsor protocols for multiple drug and device study trials within a CRO with emphasis on Phase 1 endocrinology therapeutics. This includes:
• Submitting required study documents to central IRB’s for approval
• Establishing and maintaining up-to-date study specific regulatory binders and files in preparation for internal and external audits to include ISO9001
• Creating and reviewing study specific source documents, CRF’s, ICF’s, and study protocols
• Planning for all study specific staff requirements concerning clinical operations and lab support
• Explaining IRB approved subject ICF’s and obtaining subject signatures under ICH/HIPAA requirements
• Supporting staff in day-to-day clinical activities, ensuring efficient workflow and adequate care and treatment of research volunteers
• Ensuring all study specific volunteer recruitment advertisements meet GCP requirements
• Training all staff on specific protocol related issues
• Maintaining operational interface with study sponsors, IRB’s and third-party vendors during the study’s planning stage and study implementation
• Monitoring and recording subject response to treatments such as adverse events/SAE’s Covance, Inc., San Diego, CA Nov. 2007 – Jul. 2008 Clinical Operations Supervisor
Managed 12 direct reports and ensured the logistics for multiple early phase drug trials running concurrently. Completed off-site management training required by the company. Responsible for directly supervising staff which consists of RNs, LVN/LPNs, and Research Technicians, current knowledge of ICH/GCP standards, demonstrating ability to lead by example and to encourage team members to seek solutions. Therapeutics included antibiotics, asthma, cardio, and endocrine. This includes:
• Ensuring that the safety, welfare, and dignity of subjects are not compromised
• Scheduling floor staff and investigators for protocol related tasks and clinic requirements
• Assisting with the planning of study setup, study procedures, departmental meetings, etc.
• Maintaining a safe work environment and implement safe working practices
• Assisting in the coordination of relevant protocols ensuring that the CRF’s meet customer expectations
• Ensuring the quality of service provided by team members meets the requirements of all clients
• Continuously seeking out newer and better ideas and driving best practices
• Providing performance evaluations for direct reports
• Responding constructively to management and QA ensuring that any GCP/ICH deficiencies are followed up with prompt remedial action
ANDREW D. ATALIG, CCRP Page 5
Children’s Hospital of Los Angeles Aug. 2004 – Nov. 2007 Clinical Research Coordinator III
Coordinated up to 9 late phase studies including 2 FDA drug trials that enrolled up to 20 subjects per study. Audited by the FDA for a high enrollment sponsor study and received good standing and with no 483’s. Responsible for managing several clinical research studies involving pediatric rheumatology and implementing GCP, ICH, HIPAA, and other FDA regulations and guidelines. Provide protocol submissions, amendments, ICF’s, and AE reports to local IRB committee and coordinate clinical trials to include:
• Managing the development and maintenance of timelines for clinical trials in pediatric rheumatology
• Confirming all biological samples stored and shipped during and after study trials
• Performing visual quality reviews of CRF’s and source documents as required
• Maintaining regulatory compliance for all trials
• Ensuring maintenance of accurate, current and timely distribution of trial reports to local IRB
• Performing venipunctures (phlebotomy), process lab tests, and measure vital signs at study visits
• Supervising and training research staff
• Study trials includes Phase I, II, III, and IV biological drug trials
• Main contact for sponsors and local IRB
California Clinical Trials, Glendale, CA Jan. 2004 – Aug. 2004 Clinical Research Coordinator
Managed multiple CNS drug trials with enrollment of 46 subjects sequestered for 35 consecutive days in one study and 40 subjects confined for 30 consecutive days in another study. Implemented Phase I clinical research studies according to GCP, ICH and HIPAA guidelines, Sponsor directives and Company’s standard operating procedures and policies. Experienced in running a schizophrenia study drug Phase I trials. Coordinated study trials in a hospital setting working primarily with CNS therapeutics to include:
• Creating and QA source documents with case report forms.
• Performing a variety of psychiatric rating scales.
• Supervising and training staff on Sponsor’s protocol.
• Dosing patients in a controlled setting and providing accurate documentation for drug accountability.
• Documenting medical history, concomitant meds, adverse events/SAE’s, and lab results. DermTech International, San Diego, CA Jan. 2003 – Oct. 2003 Clinical Research Coordinator
Coordinated late phase topical drug studies in a clinical site with enrollment of up to 600 subjects. Studies included repeat insult patch testing, cumulative irritation, photo toxicity, and skin sensitivity for therapeutics in corticosteroids, antibiotics, contraception, and smoking cessation. Responsible for organizing several clinical research studies and implementing GCP, ICH, HIPAA, and other FDA guidelines. Provide a written end of study report to IRB and Sponsors and coordinate clinical trials to include:
• Training and supervising staff in current company and sponsor procedures.
• Creating and reviewing source documents and CRF’s.
• Providing understanding of the Informed Consent & HIPAA forms with all subjects in a clinical trial.
• Determining subject’s eligibility through sponsor’s inclusion/exclusion requirements.
• Documenting medical history and concomitant medications.
• Performing routine phlebotomy, EKG’s, and vitals.
• Developing forms to provide for drug accountability and tracking.
• Recording all adverse events and provided detailed documentations per protocol instructions.
• Performing data entry of results with Excel spreadsheets, Access and Word programs.
• Independently resolve queries and resolutions.
ANDREW D. ATALIG, CCRP Page 6
ACCUMETRICS, San Diego, CA Aug. 2000 – Nov. 2002
Research Associate
Performed platelet aggregation on new medical device for 512K application. Instructed study staff on proper use of the medical device at different hospital and research sites. Responsible for the management of the Blood Donation Program and the development of diverse projects in a GMP environment:
• Performed clinical and software validation of Accumetric’s Ultegra instrument. Worked with formulations making a variety of buffers for use in testing and production. Built cartridges for use in testing.
• Highly proficient in phlebotomy and certified for the State of California.
• Authored SOP’s currently in use.
• Performed research validations on clinical studies of rapid platelet function assays, utilizing the Ultegra
(RPFA) and the aggregometer. Travel out-of-state for clinical trials on Accumetrics Ultegra system.
• Performed equipment validations and calibrations.
• Tested for CBC’s utilizing Coulter’s ACT-8.
• Created spreadsheets using MS Access, MS Excel, and MS Word programs.
• Trained new personnel for clinical trials and equipment protocols. AMERICAN RED CROSS, San Diego, CA Nov. 1998 – Jul. 2000 Medical Laboratory Technician
Responsible for analyzing donor blood for HIV and HCV utilizing a new DNA assay that is currently FDA approved and used worldwide.
• Analyzed donor blood for HIV/HCV utilizing Gen Probe’s HIV/HCV Amplified Assay.
• Assisted in the development of the first Nucleic Acid Testing Laboratory for the American Red Cross.
• Validated more than half of the instruments of the National Genome Testing Laboratory.
• Selected to be back-up equipment technician and was trained at the Portland ARC facility.
• Acquired strong cGMP skills and familiarization with federal codes and regulations.
• Analyzed 1400 donor samples per day operating the Tecan 150/200 instruments and Gen Probe’s Leader analyzer.
CHULA VISTA INTERNAL MEDICINE, Chula Vista, CA Jun. 1994 – Apr. 1998 Medical Laboratory Technician
Performed hematology and chemistry analysis in a four-physician clinic. Oversaw policies for: proper specimen collection; proper instrument usage; maintenance, calibration, and troubleshooting; implementing quality control and procedures; proper reagent stability and storage; evaluation of testing factors and result validity; and quarterly proficiency testing. Tests included: 14 chem profile, automated CBC’s with three-part differential, thyroid profiles, H-Pylori rapid tests, and Ion-capture Glyco HGB assays. Administrative duties included supply management, proper recordkeeping, updating SOP’s, training new personnel; and implementing safety protocols as required by CLIA and OSHA. Received certificates of completion from CIBA-Corning Express Plus Chemistry Analyzer, Abbott Cell-Dyn 1500 and IMX training. Passed all proficiency tests and CLIA inspections. EDUCATION
Bachelor’s Degree, Sociology, Central Washington University, Ellensburg, WA, 1988 Bachelor’s Degree, Law and Justice, Central Washington University, Ellensburg, WA, 1988 Associate Degree, Arts and Sciences, Pierce College, Tacoma, WA, 1985 Vocational, Basic Medical Laboratory Specialist, Academy of Health Sciences, Ft. Sam Houston, TX, 1981
Completed occupational training in Pharmacy Technician, 1994 2002 Certificate Program: Foundations of Clinical Research (Clinical Research Monitoring) Center for Clinical Research Practice and Unitek College, 2002 SOCRA certified as a Clinical Research Professional, 2007 Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites, 20 Mar 2019
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