Sr. Regional CRA

JANICE MONTEAGUDO

Home: 619-***-****

Mobile: 619-***-****

Email: **********@*****.***

EDUCATION:

University of California San Diego, La Jolla, California

MS in Clinical Research, 2009

San Diego State University, San Diego, California

BS in Child Development with minors in Biology and Health Science, 2002

HIGHLIGHTS:

• 5+ years monitoring experience in the pharmaceutical/CRO industry

• Phase I-IV experience

• Knowledge of ICH, GCP, and relevant regulatory requirements

• Self starter with strong organizational skills and attention to details

• EDC experience working with Oracle and Inform

• Demonstrates independent site management capabilities (compliance, deliverables, relationship, and troubleshooting)

• Ability to successfully managed multiple protocols (10+ trials) in varying complexity

THERAPEUTIC

EXPERIENCE:

• Oncology – Advanced Solid Tumors (i.e. breast cancer, non small cell lung cancer, colorectal)

• Infectious Diseases – Human Immunodeficiency Virus (HIV), Community Acquired Pneumonia, Invasive Aspergillosis

• Psychiatry – Sleep Maintenance Insomnia, Generalized Anxiety Disorder (GAD), Schizophrenia

• Metabolic Disease – Obesity, Diabetes

• Women’s Health – Endometriosis

• Urology – Overactive Bladder

PROFESSIONAL

EXPERIENCE:

OCKHAM

May 2010 to Present

Senior Clinical Research Associate

KFORCE CLINICAL RESEARCH

February 2008 to April 2010

Clinical Research Site Manager

INC RESEARCH

November 2006 to February 2008

Clinical Research Associate II

• Assists the project teams in the development of study monitoring plans, drafts internal and external memos, review monitoring reports as needed along with correspondence to assist in the ongoing management and coordination of assigned clinical trials.

• Serve as subject matter expert in a pilot program to reduce invalid discrepancies for RDC studies.

• Assist with ongoing training of new and experienced CRAs

• Manages all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity.

• Networks and develops region for future studies.

• Responsible for site management to include site initiation, interim and close-out according to Standard Operating Procedures

• Responsible for timely reporting of AEs/SAEs and protocol deviation

• Assist in investigator and clinical site qualification and selection, clinical site start-up activities and preparation of related study correspondence and reports

• Ensures study data submitted on Case Report Forms (CRFs) are complete, accurate and verifiable per source documents

• Participates in clinical audit of in-house study files and on-site audits as requested

• Establishes and maintains collaborative working relationships with site personnel and internal partners

• Determine and oversee site drug requirements and accountability and other supply requirements

• Willingness to travel

LIGAND PHARMACEUTICALS, INC.

January 2005 to November 2006

Clinical Pharmacokinetics Coordinator

• Co-monitored with senior CRA during monitoring visits

• Monitored the execution of studies against specified timelines, deliverables and budget

• Managed outside contractors such as CRO, central labs and consultants in review of proposals, contracts, budgets and clinical site activities (i.e. on-site training, customized investigator manuals, arrangements of couriers, etc) to ensure project requirements are met

• Participated in administrative and operational clinical research activities including assisting in pre-study site visits, designing CRF, protocol review and worked with management on developing project-specific study related tasks

• Managed all clinical trial shipments, clinical supplies and inventory control

• Coordinated bioanalytical activities for sample shipment and analysis to central labs

• Participated in development of SOPs within the Pharmacokinetics department

• Assisted in the review of draft protocols into the final study reports and regulatory submissions

• Received and inspected all clinical and biological samples, took the necessary actions if the sample did not comply with the protocol specifications and made recommendations as warranted

• Facilitated routine meetings with study teams to share issues, action items, tracking updates and new development of a project

• Contributed in developing new sample tracking system for biological samples leading to increased productivity by 100%

VETERANS MEDICAL RESEARCH FOUNDATION

June 2002 to March 2005

Research Associate II

• Managed multiple HIV studies comprising of research, data collections, record keeping and project management

• Responsible for experimental design, planning, interpretation and providing technical leadership to Research Associates and intern students on rotation

• Assumed a lead role in project planning for assigned studies to include day-to-day activities of the laboratory including training and supervision, scheduling and all aspects of administrative support

• Initiated, planned and managed the implementation of various SOP protocols and procedures

• Technical expertise and experienced in cell tissue culture (cell banking, maintenance of cell lines), virus isolation, molecular techniques (PCR, DNA sequencing), FACS analysis (Fluorescent activated cell sorting) and other novel assays

• Performed cell transfection and infection of 293T cell line, purification of pure plasmid DNA, isolate and purify nucleic acids from seminal fluid for molecular amplication technique

• Ensured equipment used storage was maintained and within calibration

LA FITNESS, Chula Vista, California

• Aerobic Instructor, 2005 to Present

• Fitness Director & Personal Trainer, 2005 to 2006

24HOUR FITNESS, Chula Vista, California

• Aerobic Instructor, 2002 to 2005

• Personal Trainer, 2001 to 2003

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