Christine de Castelbajac, R.N., B.Sc.

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Clinical Research, Project Management, Clinical Operations 4049 Avenue Hingston Montreal, Qc H4A 2J6, Canada

H: 1-514-***-**** Cell: 1-438-***-**** Email: ac2id1@r.postjobfree.com Senior research nurse manager with:

More than 25 years of nursing experience

8 years combined experience in clinical research implementation in hospitals

Had CRA training

Specialized in pharmaceuticals trials, phase II to IV in the therapeutic fields Recognized success in planning and organizing multiple complex projects. In charge of the entirety of trials from the opening until the closure, on all aspects. Highly details oriented, dedicated to insurance and quality results, working in collaboration with coordinators, investigators, sponsors and management team. Good communicator with efficient interaction, and team leader with strong problem solving and interpersonal skills. Recognized ability to lead, mentor and support a multi disciplinary team. AREA OF EXPERTISE

- Clinical operations conduct - Budget elaboration, negotiations and payments

- ICH-GCP, Health Canada, FDA rules - Project management

- Data Management - Protocol, Informed consent design

- Ethics submission process - Team building and leadership

- Development of CRF and eCRF

PROFESSIONAL EXPERIENCES

A bilingual fluent english and french

2011 – present

Senior Clinical Research Coordinator and Project Manager: Children Haematology-Oncology Research, CHU Sainte-Justine, Montreal, Canada

Specialized in pharmaceutical protocols, for 23 studies including the management of pharmaceutical (20) and institutional studies (3), Phase II, III, IV, in different specialities, and monitoring of institutional studies: Haematology: Immune Thrombocytopenic Purpura (ITP), PI: Pr G.E. Rivard Haemophilia, PI: Pr G.E. Rivard

Sickle Cell Disease, PI: Dr A. Robitaille

Immunology: Systemic Juvenile Idiopathic Arthritis (SJIA), PI: Dr E. Haddad Oncology: Histiocytoses, Registry of rare histiocytic disorders, Leukemia, PI: Dr A.S. Carret Nephrology: Acute Hemolytic Uremic Syndrome (aHUS), and nephrotic syndrome, PI Dr A.L. Lapeyraque Collaboration with different North American institutions:

Boston Children Hospital, Dr Carlos Rodriguez-Galindo

Sick Kids Hospital, Toronto, Pr Sheila Weizman and Dr Oussama Abla

University of Calgary, Pediatrics Hospital, Dr Susan Samuel

B.C. Children’s Hospital, Dr D. Dix

Pharmaceutical Industries most important partners: Amgen, Novartis, Pfizer, Eli Lilly, Alexion 2010 - 2011

Research Nurse Coordinator: Children Pharmacological Unit, Sainte-Justine Hospital, Montreal, Canada Christine de Castelbajac, R.N., B.Sc.

2 Avril 2017 2

Creation and implementation of the organisation of the unit; creation of standard of procedures (SOPs), data for pharmacokinetics protocols; ethics submissions; permanent collaboration with physicians, pharmacists and biologists; data management

2007 – 2010

Registered Nurse: Jewish General Hospital, Adults Oncology and infectious diseases, Montreal, Qc, Canada Take care of patients with with cancers (brain, breast, hepatic, pulmonary, bladder), acute and chronic diseases, acute renal failure, respiratory and infectious diseases. 2004 - 2007

Nurse in private practice, Ile de Ré, France. Take care of population of 4 villages in collaboration with 3 nurses in private practice, 150 patients.

2003 - 2004

Nurse: Adultes Neurology Medical unit, CHU of Limoges, France. Take care of patients with neurological diseases, amputated patients suffering of arthritis or diabetes. 2000 –2003

Nurse: Rehabilitation and medical unit for children, Hôpital de Garches, France. In charge of child with cerebral motor disability, or language issues.

1998 –2000 Maternity leave

1996 - 1997

Clinical Research Nurse : Adultes Clinical Investigation Center, Hôpital de la Pitié Salpetrière, Paris, France. Opening a Clinical research unit with two other nurses. Organisation of the first institutional therapeutic protocols and work with pharmaceutical trial industries. In charge of 5 trials: implementation of the protocol, elaboration of SOPs following the Good Clinical Practices (GCP), organisation. Nursing acts and procedures following protocol recommendations. Completion of case report form (CRF) and electronic form

(eCRF) and shipping.

1992 –1996

Nurse : Adultes Neurologie Medecine, Pr Agid and Lyon-Caen, Hôpital de la Pitié Salpetrière, Paris, France. Work in team on 3 services. All nursing cares for people with low mobility capacities and brain cancers. 1989 –1992

Nurse: Adultes Functional Rehabilitation, CHR Bordeaux, France. Take care in team of 28 adults patients partially or totally paralyzed. All kind of disabilities: tetraplegia, paraplegia, with brain injuries, road accident. 1987 –1989

Nurse: Adults Urological surgery, CHR Bordeaux, France. Work in team to take care of operated patients. 1986 –1987

Nurse: Adultes Functional Rehabilitation, CHR Bordeaux, France. Taking care of paralyzed patients. EDUCATION

2014: Clinician Nurse, B. Sc.- Recognition of equivalence by Quebec’s government 2009: Clinical Research Nurse, R.N. registered at OIIQ 1997: Degree of Inter-University Clinical Research Associate- Paris- France (C.R.A) Christine de Castelbajac, R.N., B.Sc.

2 Avril 2017 3

1986: Degree of Nurse - Bordeaux - France

1981: Baccalauréat - France

AWARDS

- Clinical Research Site Award recipient- 2014 by Inc. Research- Alexion

- Nominated for an award for excellence of work - 2016 by Amgen Inc. PUBLICATIONS

- New England Journal of Medecine 2015; Management of 8 patients on Prasugrel in this study

- Pediatric blood and cancer: Incremental Value of F18-FDG PET/CT in Therapeutic Decision-Making in Children Undergoing Chemotherapy for Langerhans Cell Histiocytosis

- Blood : A randomized, double-blind study of romiplostim in children with immune thrombocytopenia

- Platelets: Romiplostim therapy in children with unresponsive chronic immune thrombocytopenia

- Pediatric Nephrology : Eculizumab in atypical hemolytic uremic syndrome: long-term clinical course COMPETENCIES

Computer: World, Excel, Internet, Intranet, Sygmaplot, Winnonlin, PowerPoint Database: Inform, Infosario, Intralinks, Medidata Rave, Quintiles, EPX, RDC, RedCap, eProLog. Spanish: Intermediate Spoken, Written

MEMBERSHIP

Member of American Society of Nephrology- since 2014 Member of Histiocytosis Society- since 2012

CONTINUING EDUCATION

● IPTA- Société Québécoise de Transplantation (2011 - Montreal, CA)

● Histiocytosis Annual Meeting (2012-London, GB; 2013 - Washington, USA; 2014, Toronto, CA; 2015, Athens, GR)

● American Society of Nephrology, annual meeting (2014- Philadelphia, USA)

● Canadian Apheresis Group, annual meeting (2014- Halifax, CA)

● Pharmaceutical investigator meetings (2011 Amgen- Los Angeles; 2013 - Eli-Lilly- Phoenix, USA; 2015 - Boerhinger- Rome, IT)

● Childneph meeting (2015- Calgary, CA)

● Workshop Alexion Inc. (Toronto 2014, Toronto and Montreal 2015) ORAL COMMUNICATIONS

- Christine de Castelbajac: “aHUS Registry”, Meeting of Quebec’s nephrologist group on aHUS Registry, Montreal, CA, May 2015

- Christine de Castelbajac: “How to manage the recruitment process for aHUS Registry Study”, National aHUS Investigators meeting, Montreal, CA, October 2015 VOLONTARY WORK

- Co-leader of neighbour’s group to defense the building heritage in Montreal since 2013

- Teacher in painting art, several students since 2007 Citizenships: Canadian, French Licences: Canadian, French

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