CSS Associates

EMPLOYMENT OPPORTUNITIES

If you are interested in applying for these positions, please send your resume to sthompson@ccsainc.com.

Quality Assurance/Compliance Specialist I (Mountain View, CA)

Quality Assurance/Compliance Specialist will provide support and assistance to the QA department to assure compliance with client and company requirements and procedures. Prepares, schedules, and performs site audits to assess compliance. Assists in QA review of listing of reported adverse events and serious adverse events for all IND annual reports. Assists in QA review of reports and required study documents (e.g., efficacy, toxicology, pharmacology, drug authorization and release) and eCTD submissions for clients. Provides assistance in maintaining project files and records. Data entry into regulatory databases. Full-time position.

Qualifications: BA/BS or equivalent (combination with related work experience) in health/medical/science-related disciplines. 1–2 years experience as a QA Assistant.

Understands Good Clinical Practices, FDA, and other regulatory authorities’ compliance for clinical studies in accordance with protocols, SOPs, and regulatory requirements.

Understand scientific and/or medical terminology.

Database and word processing experience.

Attention to detail. Good communications skills.

Ability to work independently or as part of a team.

Scientist/Sr Scientist–Experience in Toxicology or Pharmacology (Mountain View, CA or Vienna, VA)

Scientist/Sr Scientist, with experience as a toxicologist or pharmacologist, who will provide support of consulting contracts; and development and management of projects within a technical program. Serves as a scientific resource and pharmaceutical agent and/or medical device expert. Prepares scientific documents (manuscripts/reports, Clinical Development Plans, INDs, Investigator’s Brochures, and protocol reviews). Contributes to database design of scientific and drug development information and biomarker search. Interacts with government and commercial clients and develops new business. Contributes to new client contract proposals. Develops necessary regulatory expertise, proposes new regulatory strategies, and participates in response to FDA comments. Sr Scientist develops and manages projects in area of scientific expertise. Full-time position.

Qualifications: PhD with >3 years relevant post-graduate experience in pharmaceutical or biotechnology industry, contract research organization, government or private research institute or academia.

Scientific training and expertise in areas relevant to program, specifically in toxicology or pharmacology, with drug development experience and expertise in animal and clinical pharmacokinetics and pharmacodynamics.

Publications in peer-reviewed biomedical journals.

Senior Scientist has experience managing scientific projects.

Excellent written and oral communication skills. Extensive scientific and technical background in biomedical sciences; skill in data analysis. Ability to work effectively without supervision.

Study Coordinator/Clinical Research Associate (Vienna, VA)

Study Coordinator/CRA, fluent in English and Spanish (Portuguese a plus), will provide support to Project Manager in sponsored clinical trial-related monitoring/auditing activities, site communications; protocol and informed consent review and maintenance; CRF and guidelines design, development, maintenance. Assists in study manual and SOP preparation and training. Performs on- or off-site visits as needed (up to 25% time in travel, including international travel). Prepares site visit reports and staff assistance. Trains site and study staff in study management including assurance to regulatory authorities (ICH/GCP compliance). Collects and processes regulatory documentation for investigational studies complying with study guidelines. Develops and demonstrates understanding and application of therapeutic area knowledge to assignments Supports data management and regulatory project teams. Liaisons with teams in project coordination. With assistance, can appropriately resolve issues related to trial monitoring and management. Full-time position.

Qualifications: BS/MS/RN or equivalent in scientific or health care field, 3–7 years of pharmaceutical, clinical, or biological research experience.

Fluent in English, Spanish; Portuguese a plus.

Working knowledge of FDA, ICH/GCP guidelines; knowledge of Latin American regulatory and general IRB requirements a plus.

Good organization, communication, writing skills. Develops and applies efficient computer tools for job function. Attention to detail. Ability to work with a team. Dependable, assumes responsibility; accepts, supports, facilitates change.