Profile of Lori Kravets-Gualtieri

Lori Kravets-Gualtieri Project Manager, Clinical Trial Manager, CRA
30 years experience 0 projects worked USA
150.00$ /hr 0$ earned
CCRA - Certified Clinical Research AssociateCCRP - Certified Clinical Research ProfessionalCMC - Chemistry Manufacturing ControlsCQA - Certified Quality AuditorCQE - Certified Quality EngineerCQIA - Certified Quality Improvement AssociateFinancial Forecasting

Project manager, lead clinical research associate and senior clinical research associate with 29 years’ experience in managing and monitoring all phases of clinical research studies for drugs and medical devices. Assertive, goal oriented and resourceful problem solver who employs excellent oral and written skills to build strong working relationships with people at all levels.  Self-motivated, equally successful as independent contributor and team player.

 

Clinical Study Experience

° Acne                                                                         ° Incontinence

° Acute Low Pain                                                        °Irritable Bowel Syndrome

° Alzheimer’s                                                               ° Mild/Moderate Renal Insufficiency

°Angioplasty                                                               ° Ophthalmic

° Cancer Pain                                                               ° Oral Carcinoma

° Cardiology                                                                ° Osteoarthritis

°Chronic Pain                                                              ° Peripheral Vascular Disease

°Common Cold                                                           ° Postmenopausal Women

°Cystic Fibrosis                                                           °Postoperative Abdominoplasty Pain

° Dental Anesthetic, Implants, Scaling, Root Canals       °Postoperative Bunionectomy Pain

° Depression/Obsessive Compulsive Disorder     °Postoperative Cataract Pain/Inflammation

° Diabetes                                                                    ° Post-Orthopedic Surgery Pain

° Epilepsy – Adult and Pediatric                                     °Posttraumatic Stress Disorder

° Hair Loss                                                                   ° Psoriasis                   

°Head/Neck Cancer                                                     ° Respiratory – Asthma                        

°Heart Failure                                                              °Sickle Cell

° Hereditary Angioedema                                              °Stroke

° Hyperlipidemia                                                          °Vaccine

° Hypertension                                                             

Work History (0)

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Work Experiences

  • Clinical Research Consultant

    MonitorLink Clinical Research

    January 1995 - Now

    Project management, GCP audits, oversight and mentoring of CRAs and study monitoring responsibilities for Phase I-IV clinical studies (30 years Phase II-IV and 25 years Phase I). Acting as liaison between CRO and sponsors. Primary investigative site responsibilities include investigator recruitment and placement of multicenter trials at national sites. Carrying out prestudy visits to evaluate the ability of an investigator to conduct a clinical trial. Conduct initiation visits to review specific aspects of the clinical trial with the investigator and staff. Perform routine scientific monitoring of clinical studies which includes the review of case report forms and/or electronic case report forms (using electronic data capture systems: Bioclinica, eClinicalOS, Medidata Rave, iMedNet, Phase Forward/InForm, Merge Healthcare/Etrials and Oracle) to ensure adherence to the protocol, consistency and scientific validity of the data. Drug accountability and regulatory documents review are also performed as part of GCP compliance. Perform closeout visits to account for all study supplies and to review study records maintenance procedures. Execute quality assurance audits to ensure that the clinical study was performed according to good clinical practice guidelines and to determine if all monitoring, drug and study record keeping and event reporting requirements were adhered to during the trial. Prepare scientific documents: case report forms (CRFs), source documents, informed consent forms, clinical reports, and monthly status reports for the conduct and implementation of clinical trials. Provide technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in a clinical program.

Certification

  • Association of Clinical Research Professionals Certification

    Association of Clinical Research Professionals

    January 2014

    Certification # A98-327

Education

  • BA, Business

    Fullerton College

    September 1983 - May 1987

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