Clinical Research Management

Celine Lee

*** ***** ***** ****

Aurora, Ontario, L4G 7T7

Tel: 905-***-****

E-mail: abqbkn@r.postjobfree.com

Summary

Clinical research professional with over 9 years of experience. Responsibilities include performing site feasibility, selection, initiation, interim, and close out visits (phases II-IV). Ensure study timelines and recruitment targets are met and that the study is conducted in compliance with GCP, FDA and ICH guidelines. Experience with Health Canada, internal, and Sponsor audits. Full site management. Team player with excellent interpersonal and communication skills.

Therapeutic Areas

COPD, asthma, GERD, Crohn’s disease, irritable bowel syndrome, ulcerative colitis, constipation, short bowel syndrome, pulmonary arterial hypertension, cardiovascular disease, hypertension, acute heart failure, hypercholesterolemia, digital ulcers, schizophrenia, Alzheimer’s disease, depression, diabetes, preeclampsia, dermatology, migraines, pain, rheumatoid arthritis, invasive fungal disease, oncology, thromboembolism, pediatric vaccines, and hypoparathyroidism.

Technical Skills

eDC (MediData RAVE, InForm), CTMS, Microsoft Office (Word, Excel, PowerPoint, Outlook), IVRS, Lotus Notes, FDA regulations, GCPs and ICH Guidelines

Professional experience

Sr. Clinical Research Associate Aug. 2011 – Apr. 2012

Actelion Pharmaceuticals, Cherry Hill, New Jersey

Full site management. On-site monitoring activities for multiple investigational sites in accordance with designated project assignments, according to SOPs, ICH/CGP and applicable regulatory requirements. Assignments included key opinion leaders and high enrolling sites.

Sr. Clinical Research Associate Mar. 2007 – Aug. 2011

Quintiles Canada Inc., St. Laurent, Quebec

Primary responsibility was site management and performance of on-site monitoring activities for multiple investigational sites in accordance with designated project assignments, according to SOPs, ICH/CGP and applicable regulatory requirements. Mentored junior CRA's.

Clinical Research Associate (contract) Aug. 2006 – Jan. 2007

Altana Pharma, Oakville, Ontario

Primary responsibility was site management and performance of on-site monitoring activities for multiple investigational sites in accordance with designated project assignments, according to SOPs, ICH/CGP and applicable regulatory requirements. Attended and participated in launch meetings and study coordinator training sessions. Provided input into monitor’s manuals, study design and recruitment strategies. Liaised with Investigators.

Clinical Research Associate Nov. 2004 – Aug. 2006

Quintiles Canada Inc., St. Laurent, Quebec

Primary responsibility was site management and performance of on-site monitoring (all types of visits) activities for multiple investigational sites in accordance with designated project assignments, according to SOPs, ICH/CGP and applicable regulatory requirements.

Clinical Research Associate Mar. 2003 – Nov. 2004

ethica Clinical Research Inc., Dorval, Quebec

Developed CRFs and assisted in the development of study protocols, amendments and informed consent forms. Full project management of the assigned clinical trials. In-house and on-site monitoring and reporting to ensure compliance with the study protocol and ICH/GCP. Liaison between sponsors, sites and IRB. Maintained Central Files. Prepared study supplies and shipments.

Data Management Associate Jan. 2003 – Mar. 2003

ethica Clinical Research Inc., Dorval, Quebec

Prepared, validated and maintained clinical databases. Reviewed CRFs for completeness, accuracy and consistency. Performed data entry. Generated data queries.

Programmer Analyst Sep. 2000 – Dec. 2002

STS Systems, Pointe Claire, Quebec

Created, managed and maintained the Automated Install Manager product. Programmed in Visual Basic, Windows script and Windows Installer. Troubleshoot hardware and software issues.

Educator Dec. 1996 – Jan. 2000

West Montreal Re-Adaptation Centre, Montreal, Quebec

Worked as an educator in group homes for physically and mentally disabled patients. Responsibilities included supervising patients and staff, administering medication, and crisis intervention.

Education

A.E.C. in Computers, December 1999 – September 2000

Dawson College, Montreal, Quebec

Nursing, September 1997 – January 1999

McGill University, Montreal, Quebec

Bachelor of Science (B.Sc.) in Exercise Science, January 1993 – May 1996

Concordia University, Montreal, Quebec

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