Amani Salama

416-***-**** ac8pip@r.postjobfree.com

Professional Summary

A dynamic and goal oriented bilingual clinical research professional with Canadian & international experience involved with more than 50 clinical trials & 15 sponsors/CROs. Expertise through monitoring has been gained in a variety of therapeutic areas including (Oncology, Hematology, Cardiology, Diabetes, Allergic Dermatitis/Eczema, Psoriasis, COPD, BA, Hyperlipidemia, Medical Devices As a physician, I'm able to bring to my work a thorough understanding of the interactions between body systems and the effects of medications or devices on each. Knowledgeable of medical regulations, quality policies and a dedication to patient safety.

Skills

MD and 10 years extensive experience in Clinical Research (hospitals & CROs).

Excellent knowledge of clinical trials process.

GMP, GVP, GCP inspections & audits.

Federal regulations( Canada, USA)

ICH/GCP

Project management.

Bilingual (English, French).

Strong organizational & analytic skills.

Ability to use various systems and databases (e.g. CTMS, EDC, TMF, IVRS).Good skills in MS office, OpenClinica, Citrix, Oracle, QMS and Track wise.

Good Documentation Practice (GDP)

Work History

Bilingual CRA, (GCP, GMP and GVP Auditor), 01/2017 to 01/2019

Crown Medical Research and Pharmaceutical Sciences College of Canada – Toronto, ON.

Leading all the clinical trial activities for 2 pharmaceuticals,10 CROs and 5 sponsors.

Multi sites (CROs) monitoring of all the activities of different Clinical Trials (Oncology, Psoriasis, Crohn’s disease, COPD, Asthma and neurology) from site selection visit till close out visit.

Conduct Qualification, Initiation, Interim and closeout monitoring visits.

Acquire specific clinical and therapeutic knowledge related to studies monitored.

Schedule, prepare and conduct bilingual GCP audits of clinical investigator sites, vendors, and CROs.

Ensure compliance to protocols, procedures and regulatory requirements.

Produce descriptive and detailed audit reports, categorize and classify audit observations.

Independently conduct external GMP & GVP Audits, prepare audit reports and communicate findings to external and internal stakeholders.

Track audit responses and auditee’s CAPA until completion and closeout.

Clinical trials monitor(2CROs) (Oncology), 12/2016 to 06/2017

HT Pharmaceuticals – Toronto, ON

Monitored 2 CROs with (120 & 92 subjects) to ensure safety and adherence to Health Canada and ICH/GCP Guidelines.

Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviewed SAE information, resolved queries and assisted sites in completion of SAE reports.

Performed source document verification, retrieved case report forms (CRFs) and performed query resolution in a timely manner.

Reviewed lab reports and clinical data; contacted sites and discussed laboratory results and actions necessary to ensure protocol consistency and patient safety.

QA Auditor, 09/2016 to 12/2016

BioPharma Services Inc. – Toronto, ON

Reviewed study files after completion an ensured that they are accurate and legible according to protocol, SOPs and regulations.

Provided reports of the reviewed data to relevant department.

Participated in review of SOPs and protocols.

Source Documents Review (SDR) and detailed review of hardcopy and electronic adverse events (AE) report forms and supplementary reports.

Observed clinical procedures during the conduct of studies, sample bundling and shipping process.

Clinical Supervisor, 11/2012 to 08/2016

Rising Minds Group Home (Adults with Autism) - Toronto, ON

Ensured that individuals with developmental disabilities are safe, healthy, and living in a clean environment.

Supervised the planning, implementation and documentation of programs designed to meet the social, emotional, physical, and personal needs of the client.

Ensured the regular and consistent completion and appropriate forwarding of all necessary written documentation, including for areas of service, administration and staffing

Monitor & Clinical Trials Associate, 12/2000 to 06/2012

Tawam Hospital -Al Ain, Abu Dhabi, U.A.E.

Conducted site selection, initiation, monitoring and close-out visits (Phase I-Phase IV) to assess the progress of clinical projects and to ensure they are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Led and monitored trials for more than 20 new medication and medical devices.

Received & reported all Product Complaints (PCs) from all the clinics and hospitals to the various manufacturing divisions and provide responses to medical inquiries.

Assessed patients to determine eligibility for specific studies based on interviews, medical history, and discussion with researchers.

Education

Bilingual Certificate Program: GMP, GVP and GCP Inspections and Audits Project Management,2018

Crown Medical Research and Pharmaceutical Sciences College of Canada - Toronto, ON

Bilingual Post Graduate Certificate : Quality Assurance and Good Manufacturing Practices, 2017

Crown Medical Research and Pharmaceutical Sciences College of Canada - Toronto, ON

Post Graduate Diploma : Clinical Research, Drug Safety and Pharmacovigilance, 2016

Academy Of Applied Pharmaceutical Sciences (AAPS) - Toronto, ON

M.D.: (M.B.CH.B), 1987

Alexandria University - Al Azaritah WA Ash Shatebi, Alexandria Governorate

REFERENCES

Available upon request.

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