CAREERS

CCSA seeks talented, qualified employees in all of our operations. CCSA offers a full benefits package (medical, dental, vision, long-term health), AD&D, life insurance, and 401k plan. CCSA is an Equal Employment Opportunity Employer.

For consideration, send resume, cover letter, and formal writing sample (where requested) to careers@ccsainc.com.*

Lead Drug Safety Physician, Clinical Research & Regulatory Affairs

Summary: Primary responsibilities include management of Safety Physicians within Drug Safety group, coordinate establishment and administration of reporting policies and procedures, review and evaluation of serious adverse event (SAE) reports within sponsor, pharmaceutical company, and regulatory timeframes, and communicate with site coordinators, clinical research associates (CRAs), and medical monitors to ensure quality and accuracy of safety reporting. Secondary responsibilities include providing CRA support as required, including clinical trial-related monitoring/auditing activities, protocol review, Informed Consent, and case report form (CRF) and guidelines development, and assist in standard operating procedure (SOP) preparation and training.

Essential Duties and Responsibilities:

  • Coordinates development and maintenance of procedures and systems for processing SAE reports within appropriate time frame for client needs.
  • Represents CCS Associates Drug Safety group to company management and clients as requested. Provides guidance on safety reporting responsibilities for regulatory agencies to clients.
  • Responsible for supervision and decision making for departmental staff.
  • Evaluates all SAE reports for completeness, accuracy, medical information, adherence to safety and regulatory standards, and reportability to regulatory authorities.
  • Ensures quality, timeliness, and accuracy of safety reporting through communication with CRAs, site coordinators, medical monitors (sponsor or CCS Associates), and other individuals involved in management of clinical trials.
  • Selects appropriate coded terms for adverse events using sponsor-defined dictionary, including COSTART, WHOART, and MedDRA.
  • Reviews SAE data against CRFs or listings, identifying discrepancies and resolving queries.
  • Develops and implements teaching strategies and tools for educating staff and sponsor on safety management and reporting.
  • Monitors federal and international regulations for new and/or changed safety requirements.
  • Prepares or reviews safety sections for documents such as clinical protocols, investigator brochures, informed consents, and clinical study reports.
  • Comprehensively reviews protocols and informed consent documents, as needed, for accuracy, completeness, and adherence to federal regulations.
  • Works closely with Regulatory Affairs staff to ensure timely Investigational New Drug (IND) safety reporting.
  • Provides site management and monitoring support for sponsored clinical studies.
  • Performs on-site pre-study/qualification, initiation, routine, and close-out visits. Prepares site visit reports and provide assistance to site staff in resolving deficiencies.
  • Educates and trains site and study staff in managing sponsored studies, including regulatory and International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) compliance.

Supervision/Decision Making Responsibilities:

  • Supervises Safety Physician staff; makes decisions with input from Senior Director, Clinical Research and Regulatory Affairs (safety) or Senior Director, Research and Development (monitoring) as needed.
  • Manages timesheets, leaves and performance for direct reports, and workflow across the team.

Qualifications:

  • Comfortable with database and word processing software.
  • Highly developed interpersonal skills to work effectively internally and externally.
  • Excellent oral and written communication skills; demonstrated ability to write concise, detailed safety narratives.
  • Experience in independent analysis and decision-making to advise sponsor representatives, study staff, regulatory personnel, and colleagues.
  • Advanced understanding of safety reporting regulations and industry practices. Working knowledge of SOPs and Food and Drug Administration, ICH/GCP guidelines.
  • Attention to detail, ability to work independently or in a team environment.
  • Experience in managing and supervising staff members.

Education and Experience:

  • MD. Minimum of eight years in drug safety data management in pharmaceutical or biotechnology research and development (in industry or clinical research organization CRO setting), five years in clinical safety, and three years of clinical research, or equivalent. Three years of supervisory experience.

Regional Clinical Research Associate – 2 Positions (East Coast, West Coast)

Summary: The Regional Clinical Research Associate is responsible for all clinical trial-related monitoring/auditing activities, protocol review, Informed Consent, and case report form (CRF) and guidelines development for all assigned sites. The Regional CRA assists in standard operating procedure (SOP) preparation and training, as needed.

Essential Duties and Responsibilities:

  • Provides site management and monitoring support for sponsored clinical studies.
  • Performs on-site pre-study/qualification, initiation, routine, and close-out visits. Prepare site visit reports and provide assistance to site staff in resolving deficiencies.
  • Educates and trains site and study staff in management of sponsored studies, including assurance to regulatory and ICH/ GCP compliance.
  • Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
  • Assist in protocol, Informed Consent, and CRF design and review.
  • Develops and demonstrates understanding of and apply therapeutic area knowledge to assignments and project-related issues.
  • Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.
  • Decisions are made independently and with some supervision from Senior Director, Research and Development or Project Manager.
  • Tasks are primarily intellectual and require exercise of discretion and independent judgment.

Qualifications:

  • Working knowledge of SOPs along with FDA and ICH/GCP guidelines.
  • Good communication, organizational, and writing skills.
  • Develops and applies efficient computer tools to carry out job functions.
  • Attention to detail, ability to work in a team environment.
  • Dependable, assumes responsibility and accepts, supports, and positively facilitates change.
  • Ability and availability to communicate with sites in different US time zones.
  • Must be willing to travel.
  • Working knowledge of Microsoft Office Suite.
  • Working knowledge of clinical trials electronic tools (CTMS, eTMF, EDC, IRT).

Education and Experience:

  • BS/MS/RN or equivalent in science or health care.
  • At least 3 years of pharmaceutical, clinical, or biological research with 1-3 years of CRA/CRC experience.

Technical Writer

Summary: Technical Writer designs and builds templates for technical and validation documentation. Assists developers with creating and executing software testing and validation. Executes and delivers data management reports for internal and external customers. Creates and maintains validation documentation from requirements generation through validation summary reporting. Assists Chief, Technology and Bioinformatics with editing and updating IT/DM portion of proposals for grants and contracts. Assists in editing and revising documents such as IT/DM standard operating procedures (SOPs), system descriptions, coding documentation, and validation documentation. Tracks and maintains IT/DM project plans and Gantt charts. Ensures that all project-required and customer-required documents are created and updated according to CCSA SOPs. This position is based in San Jose, CA.

Essential Duties and Responsibilities:

  • Designs templates for all development and validation documentation using CCSA styles as set forth in the CCSA Style Guide.
  • Assists in editing documents for accuracy and appropriate style. Checks content, sentence structure, grammar, punctuation, and spelling.
  • Verifies all documents for a given project are completed and routed for signatures.
  • Identifies missing documentation from current projects and creates them.
  • Tracks dates and versions of documents and ensures that documents are updated according to contract and SOP requirements.
  • Catalogs and maintains folder structure for document storage.
  • Assists in writing, compiling, formatting, and assembling project plans.
  • Writes, updates, and maintains SOPs for in-house and corporate IT/DM procedures.
  • Reviews SOPs to make sure changes are done on a regular basis.
  • Assists in researching, writing, revising, and producing training material for products and systems created by CCSA.
  • Assists in researching, editing, and tracking the IT/DM sections of grants and proposals.
  • Tracks project and task progress using project plan and MS Project.

Supervision/Decision Making Responsibility: 

  • Works under the direction of the Chief, Technology and Bioinformatics or designee.
  • Relies on experience, creativity, and judgment to plan and accomplish goals.
  • Approximately 75% testing, validation, and document preparation and 25% project/document tracking.

Qualifications: 

  • Understand software development and life-cycle concepts such as database (e.g., types, structures, etc.), programming (e.g., languages, coding, structure, etc.), and validation (e.g., requirements, use cases, IQ/OQ/PQ, document tracking, etc.).
  • Proficient in Microsoft Word, Excel, PowerPoint, as well as other business productivity software (e.g., Project, Acrobat, Adobe Reader, etc.).
  • Comprehensive understanding of English grammar and excellent editorial skills.
  • Strong interpersonal skills.
  • Ability to prioritize and detail oriented.
  • Ability to work independently or as part of a team, and under deadline pressure.

Education and Experience: 

  • BA/BS in Computer Science or in a Life Science with training in computer skills.
  • At least two years’ experience in technical writing or other comparable position (e.g., preparation/editing of technical manuals, user guides, etc.).
  • Submit formal writing sample (one page on a topic relevant to this position).

*Note: Incomplete applications (e.g., missing cover letter and/or writing sample) will not be considered. For the formal writing sample, if part of a multi-author publication, please explain what your contribution was.