Quality Assurance Project Manager
Resume:
RAYMOND L. HAMILTON, JR.
P.O. Box *** Belcamp, Maryland USA 21017
*.*****.********@*****.***
_______________________________________________________________________
SUMMARY OF QUALIFICATIONS
Regulatory Compliance Professional with extensive knowledge in Biomedical Ethics, Federal Regulations, Good Clinical Practice and Quality Assurance Systems.
PROFESSIONAL ACCOMPLISHMENTS
Conducted over (30) Phase I Clinical Trials
Hosted 2 successful FDA inspections within a 13-month period.
Developed and maintains over 100 Standard Operating Procedures (SOPs)
CURRENT APPOINTMENTS
Project Manager March 2011 - Present
US Immunodeficiency Network (USIDNET)
Immune Deficiency Foundation
40 West Chesapeake Avenue Suite 308
Towson, Maryland 21204
Direct Report to the Chief Operating Officer
Managing and coordinating data services for sponsors to assure project/program milestones are met according to our high standards and applicable regulations
Responsible for contract and financial management for assigned project and serves as central point of contact for the project
Manages regulatory document submission to IRB
Reviews Informed Consents and submits revisions and protocol amendments to IRB for approval
Oversees the reporting and tracking of all study deviations/violations and Serious Adverse Events to IRB and Sponsor
Ensure that selected project is conducted according to USIDNET SOPs, timelines, budgets and in support of project strategies
Responsible for tracking subject enrolment, site visits, trip reports, incentives and all phases of CRF review and collection
Maintains a high level of knowledge and understanding of assigned protocols, including all protocol requirements
Responsible for completion of all study documentation forms, including case report forms, source documents and other study specific documents.
Responsible for Annual Technical Reports to NIH
Assists Principal Investigators with protocol applications
Coordinates and manages the agenda and all follow up
Ensures all study closeout letters are submitted to the IRB at the end of the study
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Ensures all regulatory binders are maintained and contain all proper documentation
Ensures the accurate transcription of study data for source documents to paper or electronic case report forms
Oversees the development and functioning of the disease specific working group, (DSWG)
Detail-oriented, strong verbal and written communication skills.
Regulatory Compliance Specialist March 2011 – Present
SNBL Clinical Pharmacology Center
800 West Baltimore Street, 6th Floor
Baltimore, Maryland 21201
410-***-**** –Myra James, MHA, CCRP, CIM
Direct report to the Regulatory/Quality Management Manager
Responsible for ensuring all activities surrounding the conduct of clinical trials
were in compliance with the Codes of Federal Regulations, ICH/GCP Guidelines, internal SOPs, and applicable federal regulations.
Performed internal QA audits.
Responsible for the management of all Standard Operating Procedures (SOPs).
Prepared all regulatory and IRB submissions.
Created and maintained project-specific Regulatory Binders.
Developed Project-Specific Quality Management Plans and Departmental Quality
Control Plans.
Hosted Regulatory Inspections, Sponsor QA Audits and Vendor Qualification Audits.
Conducted Regulatory Compliance and SOP Training Sessions
Prepared audit agendas, plans, checklist and final report.
Prepared the research site for 2 FDA inspections.
Host all new employee and agency staff orientation sessions.
Developed and maintain the SNBL-CPC Training Matrix.
Maintained updated professional licensure (physicians, nurses, pharmacists) for all clinical staff.
EDUCATION AND TRAINING
August 1998 – May 2001
University of Maryland Eastern Shore
Princess Anne, Maryland
August 2006 – September 2006
Sojourner-Douglas College Degree: IV Therapy Technician, Phlebotomy
Baltimore, Maryland
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Regulatory Compliance Training:
Quality Assurance Workshop, OHRP
Use of Note to Files in Clinical Trial Essential Documentation, Barnett Educational Services
Good Clinical Practice, Collaborative Institutional Training Initiative (CITI)
Good Documentation Practices, SNBL-CPC
Adverse Events Reporting, SNBL-CPC
Documentation of Deviations and Violations to Study Protocol, SNBL-CPC
HIPAA: Protection of Health Information, SNBL-CPC
Protecting Human Research Participants, NIH Web-based Training
Good Quality Control Practices, SNBL-CPC
Informed Consent Process, SNBL-CPC
Human Subjects Protection Training, SNBL-CPC
Internal Quality Assurance Auditing, SNBL-CPC
Performing Vendor Qualification Audits, SNBL-CPC
Management of Training Records, SNBL-CPC
Continuing Medical Education
May 2011 – May 2011 Clinical Immunology Society Annual Meeting
Chicago, Illinois
SPECIAL SKILLS
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GCP Auditing.
Standard Operating Procedure (SOP) development.
IRB and Regulatory Submission Process.
Protocol and informed consent form development.
Strong computer skills with knowledge of MS Office suite (including Excel and PowerPoint
CERTIFICATION
2008-Present: Basic Life Support Training
American Heart Association
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PROFESSIONAL AFFILIATIONS
2011-present : SOCRA – Society of Clinical Research Associates
PREVIOUS APPOINTMENTS:
Clinical Research Coordinator May 2009 – March 2011
SNBL Clinical Pharmacology Center
800 West Baltimore Street, 6th Floor
Baltimore, Maryland 21201
410-***-**** – Robert Casper, MS
Direct report to the Director of Clinical Operations
Maintains a high level of knowledge and understanding of assigned protocols, including all protocol requirements for Patient/Subject visits, obtaining informed consents, tests, procedures, laboratory information and drug accountability requirements.
Responsible for completion of all study documentation forms, including case report forms, source documents and other study specific documents.
Coordinates and conducts patient/subject visits and assures all procedures are conducted in compliance with the clinical protocol.
Interacts with Principal Investigator as needed to assure that research participants receive appropriate medical evaluation and care when needed: alerts Principal Investigator of serious adverse events.
Interacts with sponsor to facilitate the sponsor monitoring and database clean-up process.
Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols.
Organizes all materials needed for source documentation in study binders.
Assures completions of study binders in a timely manner.
Ensure for accurate time tracking and progression of assigned clinical trials and provide updates to management team
Conducts clinical research in compliance with all applicable regulations, including GCP’s and company SOP’s.
Demonstrates knowledge and application of all privacy and safety standards as they relate to job responsibilities, human research subjects, staff and the general operation of the unit.
Perform daily Quality Control Reviews of all source document binders.
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Research Associate III August 2008 – May 2009
Research Associate I October 2006- August 2008
SNBL Clinical Pharmacology Center
800 West Baltimore Street, 6th Floor
Baltimore, Maryland 21201
410-***-**** Cheryl Duggan, CCT
Direct Report to the Associate Director of Clinical Operations
Adheres to GCPs and SNBL-CPC’s SOPs.
Performs study-related tasks and procedures, i.e. phlebotomy, vital signs, urine collection, ECGs.
Ensures that all study related activities are documented accurately and in a timely manner on source documents.
Ensures that all protocol guidelines are followed.
Exemplifies patient and staff relations in all activities.
Cooperates/collaborates with physicians and all staff members involved in the participant’s care.
Supports the implementation and application of the Initiator data base.
Performs general housekeeping, stocking supplies, bed making, cleaning and maintaining medical equipment. Serves participant’s food and refreshments.
Collaborated with clinical staff to ensure that all study activities are covered.
Participate in admission/discharge of research participants
Ensures that source documents are copied and places in study binders.
Assists in ensuring that proper study workflow is maintained, that CRF’s match protocol.
Train new Research Associated and mentor Research Associate II’s
Complete equipment maintenance checks and correct problems as needed.
Order meals per protocol requirements, ensuring that dietary restrictions are adhered to.
Maintains knowledge of protocols and ability to answer participant questions.
Periodically completes quality checks of binders and distributes to staff for appropriate corrections.
Acts as Research Associate team leader.
Assists CRC/PM’s with study preparation.
Participate in the assessment of inventory of supplies and equipment and make recommendations of management for purchases as appropriate.
Demonstrates knowledge and application of all privacy and safety standards as they relate to job responsibilities, human research subjects, staff and the general operation of the unit.
Communicates courteously with volunteers and study subjects, unit staff and representatives of study sponsor as necessary to share or obtain information relative to the performance of clinical trials.
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Phlebotomist September 2006 – March 2007
Administrative Assistant September 2005 – March 2007
Stella Maris, Inc. of Mercy Health Services
2300 Dulaney Valley Road
Timonium, Maryland 21093
410-***-**** Supervisor – Cheryl Mohn
Venipuncture with straight gauge or butterfly needles.
Collection of blood, urine and bodily fluids
Prepared specimens for processing, balance and centrifuge
Followed OSHA guidelines in processing samples and preparing for shipment to laboratory.
Executive Assistant for the Director of Dietary.
Scheduled staff and tracked time and attendance.
Set up appointments
Managed accounts payable and vendors.
CLINICAL RESEARCH SUPPORT
2011
A Phase I Randomized, Open-label, Cross-Over Study of the Pharmacokinetics, Dermal Tolerability, and Safety of MRX-7EAT with an Extension Study of Occlussive Overlays in Healthy Volunteers.
ATI-CL12: An Open-Label, Randomized, Parallel Group, Phase 3 Study of the Contraceptive Efficacy and Safety of XXX Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-Dose Oral Contraceptive Containing XXX l and XXX in a 21-Day Regimen.
A Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of XXX as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson’s Disease.
A Phase I Randomized , Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of ASP3291 Following a Single Oral Dose in Subjects with Moderately Active Ulcerative Colitis.
A Cerebrospinal Fluid Collection Study in Normal Healthy Adult Volunteers.
A Phase 1a, Double-Blind, Placebo-Controlled, Single, Ascending Dose Escalation Study to Determine the Pharmacokinetics and Safety of FGI-101-1A6 Administered as an Intravenous Infusion in Sequential Cohorts of Healthy Adult Volunteers.
An Open-Label Study to Evaluate the Effect of Repeated Administration of XXX on the Pharmacokinetics of XXX in Healthy Subjects.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients with Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC).
An Open-Label Study to Evaluate the Effect of Repeated Administration of XXX on the Pharmacokinetics of a Single Dose of XXX (15 mg) in Healthy Subjects.
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A Randomized, Open-Label, 3-Arm, 3-Period Crossover Study to Evaluate the Pharmacokinetics (PK) and Safety of Tsumura Daikenchuto Extract Granules (TU 100) in Healthy Volunteers in the United States.
A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-00547659 in Subjects with Crohn’s Disease who are Anti-TNF Inadequate Responders (OPERA).
A Phase 1, Single Center, Randomized (2-Sequence), Single Blind, 3-Period Study Comparing the Safety, Tolerability, and Pharmacokinetics of XXX Controlled Release Capsules with XXX Immediate Release Tablets in Male Adult Volunteers.
A Study of the Pharmacokinetics and Metabolism of XXX Sweetener after a Single Oral Dose in Healthy Male Subjects.
A Phase I, Prospective, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Escalating, Single-Dose Study Designed to Determine the Maximum Tolerated Oral Dose of NW-3509A in Healthy, Male Volunteers.
Phase I, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Combinations of H1 and H5 Influenza Hemagglutinin Plasmids Administered Intradermally Followed by In Vivo Electroporation wit Cellectra -3P in Healthy Adults.
Evaluation of Pharmacokinetics of XXX following Single and Repeat Oral Administration of XXX Capsules in Healthy Postmenopausal Women.
A Phase 1/2 Placebo-Controlled, Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Imunogencity of 3 Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4AG) in Healthy Adults.
An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients with Non-Cancer-Related Pain.
A Pilot Pharmacokinetics study in healthy volunteers to examine the relative bioavailability of TRZ (Intranasal zolmitriptan powder formulation) to Zomig® (zolmitriptan) tablet and nasal spray.
Multicenter Open-Label Extension Study for PF-00547659 (OPERA II).
2010
A Phase 1 open label Study to Evaluate the Safety and Tolerability of XXXX by Subcutaneous Administration in Normal Healthy Adult Subjects.
Global Clinical Study on Ethnic Differences in Drug Metabolism Based on the Announcement by the Japanese, Chinese and Korean Ministers of Health, Labor and Welfare.
A Clinical Validation Study of the Analysis of Cell Bound Complement Activation Products (CB-CAPS) and Double Stranded DNA Auto-Antibodies in Subjects with Systemic Lupus Erythematosus versus Other Rheumatic Diseases and Healthy Normal Volunteers.
A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SingleDoses of Orally Administered XXXX, an Inhibitor of Bruton's Tyrosine Kinase, in Healthy, Adult Subjects: A Double-blind, Placebo-controlled, Ascending Dose Study.
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Protocol to Measure the Outcome of Human B Cell Enrichment from Whole Blood Obtained from Healthy Donors.
A Phase 3b, Double-Blind, Randomized, 12-Week Efficacy and Safety Study Comparing the XXXX Plus XXXX Fixed-Dose Combination vs. XXXX -XXXX in Subjects with Moderate to Severe Hypertension.
A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Arthritis Non-Inferiority Study of XXXX1 versus XXXX for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates.
A Phase 1 Open Label Study to Evaluate the Safety and Tolerability of XXXX by Subcutaneous Administration in Normal Healthy Adult Subjects.
Global Clinical Study on Ethnic Differences in Drug Metabolism Based on the Joint Statement by the Japanese, Chinese and Korean Ministers of Health.
Clinical Pharmacokinetic Study of XXXX in Healthy Adult Male Subjects.
An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of XXXX 5 mg After Single and Multiple Oral Administration to Patients with Type 2 Diabetes Mellitus of African American Origin for 7 days.
Phase I, Double-Blind, Placebo-Controlled, Ascending, Multiple-Dose, Safety, Tolerability and Pharmacokinetic Study of XXXX Capsules in Healthy Adult Volunteers.
An Open-Label, Randomized, Single-Dose, 3-Sequence Cross Over Design, Relative Bioavailability Study Comparing 20 mg Capsule Versus 20 mg Tablet and 20 mg Solution Formulations of XXXX in Healthy Male Subjects.
2009
A Phase I Open Label, Volume Escalation Study to Evaluate the Safety and Tolerability of XXX
by Subcutaneous Administration in Normal Healthy Adult Subjects.
Phase I - II, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Safety and Efficacy Study in Healthy Adults of Intranasal Norwalk Virus-like Particle Vaccine in Experimental Human Norwalk Virus Infection.
A Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen XXXX for the Prevention of Pregnancy in Women.
A Single-Center Randomized, Double-Blind, Placebo-Controlled Phase I Trial to Assess the Safety
and Tolerability of Single and Multiple Daily Oral Administration of XXXX Live Biotherapeutic in Healthy Adult Subjects.
Pharmacokinetics and Safety of a Single Oral Dose of XXXX and XXXX Administered With and Without
Food in Healthy Volunteers.
Open-Label Study Comparing the Relative Bioavailabilities of Two XXXX Salts and XXXX Free Base.
A Phase I Open-Label, Dose Escalation Study of the Safety, Dermal Tolerability and Pharmacokinetics
of XXXX in Healthy Volunteers, After Administration of a Single or Multiple Topical Patch (es) in a Parallel Fashion.
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A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy adults.
A Longitudinal Study in Healthy Adult Volunteers Aged 18 to 85 Years to Describe Antibody Levels
to Antigens Expressed by Staphylococcus Aurens and B-Hemolytic Streptococci Species, and to Describe Carriage of these Bacteria.
A Phase I, Double-Blind Crossover Study of the Acute Tolerability of Immediate Extended Administration of XXXX in Normal Healthy Volunteers.
A Phase 1 Double-Blind, Placebo-Controlled, Single-Center Dose Escalation Study to Evaluate the Safety and Tolerability and Pharmacokinetics of Intramuscular Administration of a New Oxime.
A Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Phase I Study of the Safety and Tolerability of Intravenously Administered XXXX in Healthy Volunteers.
A Phase I Randomized, Double-blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of XXXX when Administered Intravenously to Subjects with Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
A Phase II Open Label Study of XXXX Administered Concomitantly with XXXX to Patients with Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials.
Blood Collection in Healthy Adult Volunteers to Obtain Serum for Use in Serum Bactericidal Activity Assay Development.
A Randomized, Partially Double-Blind, Placebo-Controlled, 28-Day Repeat Dose, Dose-Range Study to
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of XXXX, with a Comparison to Subcutaneous Forteo, in Healthy Postmenopausal Women.
A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study Comparing the XXXX Plus XXXX Fixed-Dose Combination vs. XXXX® (XXXX) in Subjects With Moderate to Severe Essential Hypertension.
A Phase 3, Randomized, Double-Blind, Cross-Over, Active-Controlled Study of the Efficacy and Safety of XXXX, XXXX-(XXXX), for the Treatment of Adults with Urea Cycle Disorders (Help UCD).
A Phase 3, Open-Label Study of the Safety of XXXX for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD).
2008
A Double-Blind, Randomized, Placebo-Controlled, Phase I/II Trial to Evaluate the Safety of Dapivirine Gel 4759, 0.05% 2.5g and Dapivirine Gel 4789, 0.05% 2.5g Formulations as Compared to the Vaginal Hec-Based Universal Placebo Gel, 2.5g in Healthy HIV-Negative Women.
An Open Label, Single Dose, Randomized, Active Controlled, Two-Period, Two-Sequence Crossover Pharmacokinetics Study to Assess the Bioequivalence of the XXXX, a XXXX Transdermal Formulation vs. XXXX 12mg/ Day after a Single Dose in Healthy Volunteers.
A Phase 1 Open Label Placebo Controlled Multiple Dose Study to Evaluate the Pharmacokinetics of
XXXX for Injection Dosed Two and Three Times Daily in Healthy Subjects.
A Phase I, Open Label, PET Study in Healthy Subjects Following a Single Oral Dose of XXXX.
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An Invivo Positron Emission Tomography Study of the XXXX in Healthy Subjects, in Patients with
Schizophrenia.
A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety and Pharmacokinetics of XXXX in Healthy Subjects.
An Open-Label Formulation Screening Study to Evaluate the Safety, and Tolerability,Pharmacokinetics of a Single Dose and Multiple Doses of Delayed Release XXXX in Healthy
Subjects.
(Additional Cohort) - A Randomized, Open-Label Study to Assess the Effect of Ketoconazole on XXXX Pharmacokinetics and Pharmacodynamics.
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