Project Quality Assurance
Resume:
Melanie L. Lee, RN
*********@*****.***
education
Associate Degree in Nursing, 1980
University of Charleston, Charleston, WV
Professional experience
PPD, Wilmington, NC Sr. Clinical Review Specialist
April 2014-present
Clinical Review Specialist May 2011-Mar 2014
Safety
Specialist Mar 2008-April 2011
Senior Clinical Review Specialist
. Provides clinical review training to all CDM staff performing clinical
review activities.
. Participates in the development and implementation of processes,
procedures and training for the data management function, as directed.
. Mentor new staff
. Review patient data in accordance with GCP, SOPs/WPDs, and DVMs.
. Liaise with colleagues in other functional groups and management
regarding data review activities for allocated studies.
. Read and understand project protocols and DVMs.
. Reviews patient data in accordance with the Clinical Listings Reviews
Plan in the DVM.
. Perform in-depth reconciliations of subject data collected during
clinical drug trials and identify discrepancies and medically incorrect
data.
. Perform analysis of study data to identify trends and potential target
signals.
. Generation and issuance of queries in the project's electronic database.
. Identifies data issues and works with PPD team to resolve.
. Ensure data accuracy according to departmental operating procedures.
. Ensure applicable data review activities are completed in a timely manner
and meet quality expectations.
. Provide support, guidance and direction on clinical data review to the
CDM project team including consultation related to Listing Review and
related section of the DVM.
. Assists supervisor with the maintenance of the Project Log and
accumulation of the monthly metrics data.
Clinical Review Specialist:
. Reviewed patient data in accordance with GCP, SOPs/WPDs, and DVMs.
. Liaised with colleagues in other functional groups and management
regarding data review activities for allocated studies.
. Read and understood project protocols and DVMs.
. Reviewed patient data in accordance with the Clinical Listings Review
Plan in the DVM.
. Perform in-depth reconciliations of subject data collected during
clinical drug trials and identify discrepancies and medically incorrect
data.
. Perform analysis of study data to identify trends and potential target
signals.
. Generation and issuance of queries in the project's electronic database.
. Ensured data accuracy according to departmental operating procedures.
. Ensured applicable data review activities are completed in a timely
manner and meet quality expectations.
. Provided support for clinical data review to the CDM project team.
Safety Specialist:
. Responsible for processing Serious Adverse Event (SAE) which included
review of source documents, safety database entries, tracking, narrative
writing, requesting follow-up from site and reporting to client (s) or
agencies for assigned projects.
. Responsible for adhering to PPD's corporate policies, SOPs/WPDs, and
awareness of ICH GCP guidelines.
. Effectively interfaced with Project Teams, Client Companies, and
Investigators regarding SAE activities.
. Reviewed and understood assigned study specific budgets.
. General understanding of pathophysiology and the disease process, more
detailed knowledge of relevant therapy areas as required for processing
SAEs.
. Ensured any expedited safety reports were notified to applicable
Regulatory Authorities, Ethics Committees and Principal Investigators
within regulatory timelines.
. Responsible for coordinating serious adverse event reviews, tracking, and
reporting to sponsor (s) or agencies for assigned projects.
. Responsible for daily compliance tracker and safety specialist metrics
which tracked all SAEs received and processed for assigned project.
. Performed quality assurance reviews of narratives.
. Performed SAE reconciliation on a quarterly basis.
. Performed SAE/pregnancy transmission verification.
. Provided project specific safety training to PPD clinical on assigned
projects.
. Served as the Lead Safety Specialist with all project management
responsibilities
Dr. Douglas F. DeGroote, DDS, OMS, Wilmington, NC
RN Aug 1997-Mar 2008
. Provided primary care of pediatric to geriatric patients with dental and
oral pathology conditions and performed as a surgical assistant with
procedures.
. Obtained medical histories with emphasis on current medication, possible
medication interactions with anesthetics and standard office
prescriptions, and possible adverse reactions.
. Care of patients under anesthesia with hemodynamic monitoring,
capnography, and pulse oximetry with specialized training in cardiac
rhythm interpretation and appropriate interventions per ACLS/AHA
protocols.
. Clinical managerial duties: scheduling of outpatients procedures and
tests, development of office clinical procedures and documents,
maintenance of MSDS records, clinical support of the surgical staff
including training with continuing education program development and
presentation.
New Hanover Regional Medical Center, Wilmington, NC
RN Aug 2005-Mar 2008
Aug
1982-Aug 1997
. Primary care of adult/pediatric post-surgical patients including
hemodynamic, cardiac monitoring, ventilator management, and maintenance
of multiple intravenous infusions of trauma and critical patients.
. Communication with staff, physicians, family members, and visitors.
. Member of the quality assurance, document development and scheduling
committees.
. Patient and family education.
Charleston Area Medical Center, Charleston, WV
RN Jun 1980-Aug 1982
. Primary care of acute cardiac adult patients with hemodynamic and cardiac
monitoring
. Advanced critical care education
. Patient and family education
. Clinical manager of shift employees
THERAPEUTIC EXPERIENCE
Circulatory: Angina, Cardiac Dysrhythmias, Coronary Artery Disease,
Cerebrovascular Disease/Events, Congestive Heart Failure, Hypertension,
Myocardial Infarction, Thromboembolism, Thrombophlebitis, Abdominal Aortic
Aneurysms, Peripheral Vascular Disease, Thrombolytic Therapies, Coronary
Arteriograms, Arteriosclerosis, Surgical Procedures Relevant to Treatment
Dermatology: Cellulitis, Abscess, Dermatitis, Psoriasis, Eczema, Shingles,
Keratitis, Alopecia, Decubitus Ulcer, Urticaria, Surgical Procedures
Relevant to Treatment
Digestive System: Crohn's Disease, Duodenal/Gastric Ulcer, Esophageal
Disorders, Gallbladder Disease, Gastritis, GERD, Ulcerative Colitis, Bowel
Obstruction, Gingival/Periodontal Disease, Irritable Bowel Syndrome, Viral
Hepatitis, Gastrointestinal Hemorrhage, Diverticular Disease, Hemorrhoids,
Hernias, Impacted Teeth, Dental Implants, Surgical Procedures Relevant to
Treatment
Endocrine/Metabolic: Cirrhosis, Diabetes, Thyroid Disease, Gallbladder
Disease, Pancreatic Disease, Pituitary Disorders, Obesity, Lipoid
Metabolism Disorders, Surgical Procedures Relevant to Treatment
Eyes: Macular Edema, Cataracts, Retinal Detachment, Glaucoma, Traumatic
Injuries, Retinal Vein Occlusion, AMD, Surgical Procedures Relevant to
Treatment
Genitourinary: Bladder and Renal Stones, Cystitis, Glomerulonephritis,
Renal Insufficiency and Failure, Renal Surgical Procedures, UTI, Prostate
Disorders and Surgical Procedures, Erectile Dysfunction, Endometriosis,
Dysmenorrhea, Surgical Procedures Relevant to Treatment
Hematology: Anemia, Blood Dyscrasias, Coagulation Disorders, Sickle Cell
Anemia
Infections/Parasitic Diseases: Auto-Immune Hepatitis, C Diff, Hepatitis,
HIV/AIDS, Influenza, MRSA, Pseudomonas, Septicemia, Staph, Strep, TB, VRE,
Dental Abscess, Pneumonia, Infection Control
Injury/Poisoning: Abdominal/Multiple Organ Injuries, Fractures,
Intracranial Injures, Multiple Trauma Injuries, Spinal Cord Injuries,
Inhalation and Pharmacological Poisonings, Surgical Procedures Relevant to
Treatment
Mental Health: Bipolar Disorder, Chronic Pain, Depression, Electroshock
Therapy, Narcotic Dependence, Obsessive Compulsive Disorder, Anxiety, Panic
Disorders, Phobic Disorders, Alcohol/Drug/Tobacco Dependence, Eating
Disorders, Schizophrenia, Fragile X Syndrome, Autism
Musculoskeletal: Psoriatic Arthritis, Rheumatoid Arthritis, Systemic Lupus
Erythematosus, Sjogren's Syndrome, Osteoarthrosis, Osteomyelitis,
Periostitis, Osteoporosis, Osteonecrosis, Temporomandibular Joint
Disorders, Mandibular Fractures, Dental Alveolar Anomalies, Oral and
Maxillofacial Surgeries, Degenerative Joint Disease, Spinal Disorders
Fractures, Orthopedic Surgeries and procedures
Nervous System: Alzheimer's Disease, Cerebral Palsy, Epilepsy, Multiple
Sclerosis, Neuralgias, Nerve Injuries, Seizure Disorders, Senile Dementia,
Parkinson's Disease, Migraine, Pain, Peripheral Neuropathies, General
Anesthesia, Spinal Anesthesia, Local Anesthesia, MAC Anesthesia, Regional
Anesthesia and Nerve Blocks, Cerebral Hemorrhage, Cerebral Aneurysms,
Cerebral Tumors, Intracranial Pressure Monitoring, Surgical Procedures
Relevant to Treatment
Oncology: Brain, Breast, Cervical, Colon, Stomach, Bone, Dermatological,
Head/Neck/Oral Pathologies, Lung, Melanoma, Prostate, Uterine, Bladder,
Kidney, Thyroid, Hodgkin's Disease, Multiple myeloma, Liver, Surgical
Procedures Relevant to Treatment
Respiratory: ARDS, Asthma, COPD, Emphysema, Pneumonia, Pulmonary
Edema/Emboli, Sleep Apnea, Acute Sinusitis, Acute Pharyngitis, Acute
Tonsillitis, Influenza, Bronchitis, Respiratory Distress Syndrome,
Bronchospasm, Laryngeal Spasm, Cystic Fibrosis, Perennial Allergic Rhinitis
(PAR), Seasonal Allergic Rhinitis (SAR), Surgical Procedures Relevant to
Treatment
Transplants: Bone marrow, kidney, liver
LIcenses & Certifications
. RN licensure, North Carolina, Certificate No. 078531
computer experience
Windows, Microsoft Office: Word and Excel, Internet Navigation, Electronic
databases: Medidata RAVE, Oracle AERS, Phase Forward Inform and Oracle
Clinical, Adobe Acrobat 8 and 9 Professional, Direct Connect, Livelink,
Data Review Utility, RightFax Utility
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