Resume

Sign in

Clinical Research Associate

Location:
Ontario, Canada
Salary:
open
Posted:
September 30, 2008

Contact this candidate

Resume:

CLINICAL RESEARCH ASSOCIATE III

Q.F.B Olivia E. Hernandez, B. Sc

EDUCATION

B.S Pharmaceutical Chemist and Biologist.

Universidad Nacional Autónoma de México.

THERAPEUTIC EXPERIENCE

- Cardiovascular: Pulmonary Hypertension

- Respiratory: Asthma

- Musculoskeletal: Lupus Nephritis

- Ophthalmology: Macular Edema

- Genitourinary: Premature Ejaculation

- Oncology: Bone Metastases, Head and Neck and Lung cancer.

PROFESSIONAL EXPERIENCE

PPD DEVELOPMENT, MEXICO CITY.

Clinical Research Associate III 2008 - Present.

Visit investigative sites to assess facility/staff, implement protocols and ensure site compliance with protocol specifications and regulatory obligations, making recommendations as warranted. Documents observations in reports and letters in a timely manner using approved business writing standards. Verify accurate source documentation and validate CRF entries, assisting with query resolution as needed. Assess investigational product accountability through physical inventory and records review. Review regulatory documents and maintain required files at the site and at PPD. Produce quarterly file audits and address any discrepancies. Facilitate effective communication between investigative sites, the Client Company and the PPD project team through written, oral and/or electronic contacts. Respond to company, client and federal regulatory requirements/audits. Serve as a resource for site personnel and the project team. Identify potential investigators in collaboration with the Client Company to ensure the acceptability of qualified investigative sites. Contribute to the project team by mentoring new members, assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Maintain and complete expense reports in a timely manner.

Clinical Research Associate II 2006-2008

Visit investigative sites to assess facility/staff, implement protocols and ensure site compliance with protocol specifications and regulatory obligations, making recommendations as warranted. Document observations in reports and letters in a timely manner using approved business writing standards. Verify accurate source documentation and validate CRF entries, assisting with query resolution as needed. Assess investigational product accountability through physical inventory and records review. Review regulatory documents and maintain required files at the site and at PPD. Facilitate effective communication between investigative sites, the Client Company and the PPD project team through written, oral and/or electronic contacts. Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Respond to company, client and federal regulatory requirements/audits. Contribute to the project team by mentoring new members, assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Other project related work as assigned.

Clinical Research Associate I 2004- 2006

Verify accurate source documentation and validate CRF entries, assisting with query resolution as needed. Assess investigational product accountability through physical inventory and records review. Visit investigative sites to assess facility/staff, implement protocols and ensure site compliance with protocol specifications and regulatory obligations, making recommendations as warranted. Documents observations in reports and letters in a timely manner using approved business writing standards. Review regulatory documents and maintain required files at the site and at PPD. Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Maintain and complete expense reports in a timely manner. Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Respond to company, client and federal regulatory requirements/audits. Contribute to the project team by mentoring new members, assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Other project related work as assigned.

Provided day-to-day administrative support/clinical support to the team, maintains central study files (including regulatory documents) for assigned projects; interacts regularly via telephone with investigators, team members and sponsors on various project-related issues, tracks important study data (enrollment, adverse events, investigator payment information) in the RTMS database and offers organizational and administrative expertise.

JAMIESON LABORATORIES LTD, WINDSOR CANADA.

Analyst Jun- Sep 2004

Co-op program working in the QC department a quality control technologist.

• Analysis of products (bulk and finished) by Infrared, UV and HPLC.

WYETH PHARMACEUTICALS, S. A DE C.V MEXICO CITY.

Quality Control Chemist Nov2001- Oct-2003

In the Nutritional department as a quality control chemist.

• Tested raw materials and finished product for infant formula.

• Analysis of fats, vitamins, proteins, solids etc by HPLC and/ or UV.

• Microbiological analysis and environmental monitoring.

• Water monitoring and microbial identification.

• Continuous training and reviewing of SOPs, methods and metrics of the company.

BRULUART S.A DE C.V, LABORATORIO DE MEDICAMENTOS Y PRODUCTOS BIOLOGICOS. STATE OF MEXICO.

Quality Control Chemist 1998-2001

• Tested of raw materials, bulk and finished product of tablets, syrups and injections for diabetes, hypertension, analgesics, antibiotics, allergies, asthma and antihelmintics.

• Calibration of equipment (dissolution test system, UV, balances).

PROFESSIONAL DEVELOPMENT

Thesis: Determination of the minimal inhibitory doses of 3 Quinolones Antibiotics for Actinobacillus pleuroneumoniae.

LICENSES & CERTIFICATIONS

• Bachelor Science in Biological Pharmaceutical Chemistry, UNAM

COMPUTER EXPERIENCE

Microsoft software Internet, MS Word, Excel.

LANGUAGES

Proficient in Spanish and English.

Intermediate level of French language.

CLINICAL TRIAL EXPERIENCE.

Oncology: A Phase 3 randomized trial of chemotherapy with or without study drug in patients with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck.

A randomized, double-blind, multicenter study of study medication compared with Zoledronic acid (Zometa®) in the treatment of bone metastases in subjects with advanced cancer (excluding breast and prostate cancer) or Multiple Myeloma.

A randomized, double-blind, multicenter study of study medication compared with Zoledronic acid (Zometa®) in the treatment of bone metastases in subjects with advanced breast cancer.

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of study medication in combination with Paclitaxel and Carboplatin for advanced non- small cell lung cancer.

Respiratory: A multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group to assess the efficacy of study medication metered dose inhaler at a daily dose of 160 ug administered either in a once-daily in the morning regimen (160 ug qd AM) for 16 weeks or in a 160 ug qd AM regimen for 12 weeks preceded by a twice-daily regimen (80 ug bid) for 4 weeks, or in an 80 ug bid regimen for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids.

Circulatory: Clinical Protocol FPH03 (STRIDE-III): A Long-Term, Open-Label Study to Evaluate the Safety of Study medication Treatment in Patients with Pulmonary Arterial Hypertension.

Musculoskeletal: A prospective, randomized, active controlled, parallel group, multi-center trial to assess the efficacy and safety of Investigative Study Medication in inducing response and maintaining remission in subjects with lupus nephritis.

Genitourinary: A Placebo-controlled, Double-Blind, Randomized, Parallel-Group study for the efficacy and safety of Study Medication in the treatment of subjects with premature ejaculation.



Contact this candidate