609-***-**** ǀ adha7f@r.postjobfree.com

Brunella Di Meglio

Experience

IQVIA, Inc., NC, USA

Senior Clinical Research Associate – Feb. 2019 – Present

Ensure adherence to GCP and protocol requirements, to maintain study patient safety

Responsible for all aspects of study site monitoring, including all site visits

Prepare clear and accurate Trip Reports within required timeframe

Site Management

Implement study specific communication plan as assigned

Managed team training and reconciliation

Covance, Inc., Princeton, NJ USA

Site Selection Lead II, Feasibility – Jun. 2018 – Jan. 2019

Globally review and suggest sites for sponsor review and selection.

Conduct site outreach for study feasibility for bid defense

Facilitate the site id process from selection to PSV.

Initiate and manage the outreach process, including CDA completion, site scoring, and survey responses.

Senior Site Specialist, ECD – Apr. 2017 – Jun. 2018

Site contract and budget Negotiations

Verification of regulatory documents

Confirmation of site GCP

Maintain study files

Oversee timely collection of required documents

Support Feasibility assessments at country level

Ensure high quality site documents are filed in the TMF according to study plan

Work with staff in Business Development and Operations to provide critical input for successful trail execution

Clinical Research Associate – Nov. 2014 – Mar. 2017

Responsible for all aspects of study site monitoring, including all site visits.

Maintain study files

Ensure adherence to GCP and protocol requirements, to maintain study patient safety

Preform CRF review, query generation and resolution

Create Trip Reports in a clear and correct information is provided within required timeframe

Prepare accurate and timely trip reports

Site Management

Trip Report Review within the specified timeframes

eTMF file reconciliation

Implement study specific communication plan as assigned

Followed FSP Model

Managed team training and reconciliation

Clinical Research Assistant - Jun. 2011 – Oct. 2014

Interact with investigational sites to ensure site preparation and compliance

Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data

Management of vendors to ensure study supplies at sites and initiate supply shipments

Create, update, track, and maintain study-specific trial management files, tools, and systems.

Assist the local project team members with other administrative activities as required (e.g. correspondence with clients, preparation of status reports, and organization of investigators’ meetings)

Co-ordinate meetings with clients, and project team, including taking minutes.

Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work

Creating and distributing monthly newsletters to investigational sites

General On-Site Monitoring Responsibilities:

oAssist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)

oInitiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors

Perform other duties as assigned by management

Montgomery Internal Medicine Group, Princeton, NJ, USA

Certified Medical Assistant - Feb. 2006 – May 2011

Venipuncture

Administered EKG’s

Administered Subcutaneous and Intramuscularly Injections

Obtained Patient History

Collected Ultrasound Data for Carotid Artery Study

Vision Testing

Patient Vital Signs

General Laboratory Maintenance

Patient Wound Care

Prescription renewals

University Medical Center at Princeton, Princeton, NJ, USA - Nov. 2005 – Oct. 2006

Registered Phlebotomy Technician - Nov. 2005 – Oct. 2006

Venipuncture

Preparing Laboratory Samples

Processing Samples for analysis

Martin J. Scott D.O. & Associates, Mercerville, NJ, USA - Oct. 2004 – Nov. 2005

Medical Assistant - Oct. 2004 – Nov. 2005

Venipuncture

Administered EKG’s

Administered Subcutaneous and Intramuscularly Injections

Assisted in Surgical Procedures

Obtained Patient History and Vital Signs

Vision Testing

Urinalysis and Urine Drug Testing

Patient Wound Care

Patient Referrals

Audiometry Testing

General Laboratory Maintenance

Merrill Lynch, Pierce, Fenner & Smith, Incorporated, Pennington, NJ, USA - Sep. 1999 – Jun. 2004

Technology Implementation Specialist - Apr. 2002 – Jun. 2004

Created System Requirements

Tested System Usability

Created User Interfaces

Maintained relationship with current and potential Print On Demand vendors

Project Manager -Retirement Group - Sep. 1999 – Mar. 2002

Created and managed profit generating publications

Maintained relationship with current and potential Print On Demand vendors

Supported literature distribution and maintenance for various product relationships

Therapeutic Experience

Oncology: Prostate, Thyroid, Hepatic

Respiratory: COPD, Asthma, Pneumonia

Hyperlipidemia:

Cardiovascular: Hypertension, Congestive Heart Failure/ Cardiac Edema, Arterial Fibrillation

Dermatology: Wound care

Endocrine: Diabetes Mellitus, hypothyroidism, hyperlipidemia, thyroid cancer

GI/Hepatic: Chron’s Disease, Abdominal pain, ESRD

Infectious Disease: Skin and soft tissue infections, vaccines for infectious diseases

Immunology: Seasonal allergies

Hematology: Hemophilia, Anemia (decreased hgb, hematocrit, rbc)

Musculo-Skeletal: Pain- acute

Education

Certificate, Medical Assistant, Sanford Brown Institute / Ultrasound Diagnostic Schools, Iselin, NJ, USA

Bachelor of Art, Communication, Minor, Administrative Healthcare, Rutgers University, Cook College, New Brunswick, NJ, USA

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