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.

Regional Clinical Research Associate (East)

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

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 demonstrate 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 scientific or health care.
At least 3 years of pharmaceutical, clinical, or biological research with 1-3 years of CRA/CRC experience.

Regional Clinical Research Associate (Midwest)

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

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 demonstrate 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 scientific or health care.
At least 3 years of pharmaceutical, clinical, or biological research with 1-3 years of CRA/CRC experience.

Senior Director, Clinical Research and Regulatory Affairs

Senior Director, Clinical Research and Regulatory Affairs is a member of CCS Associates staff with responsibility for managing, planning, and supervising projects in regulatory affairs, pharmaceutical resources, safety, and research data analysis for the company as directed by the President, CEO.

Responsibilities

Oversees, plans, and manages all project activity in Clinical Research and Regulatory Affairs or as assigned by the President, CEO.
Oversees development, review, and implementation of relevant SOPs and work processes in collaboration with QA staff.
Manages Clinical Research and Regulatory Affairs staffing, training, and performance aspects of staff.
Acts as a liaison to the President, CEO; other directors and senior directors; and clients. As requested by the President, CEO, may stand in for the President, CEO in interactions with clients.
Participates in business development in areas relevant to responsibilities.
Participates in planning and prioritizing projects for Clinical Research and Regulatory Affairs.
Serves as a member of the management team; in charge of budgeting for Clinical Research and Regulatory Affairs.
Supervises and makes decisions for Clinical Research and Regulatory Affairs staff.

Qualifications

Possesses excellent managerial, communication, organizational, oral, and writing skills.
Has experience in US and international regulatory affairs for drug, biologics, and device development.
Has ability to work in a team environment; can effectively and appropriately resolve issues.
Is considered an expert in scientific/technical area; is recognized as expert outside of company by scientific/technical publications, invited presentations, and/or participation in professional societies.
Develops and applies efficient computer tools and software applications to carry out job functions.
Has ability to train and be a mentor to other staff.
Possesses a track record of multitasking, prioritizing and managing projects, and effectively implementing change.
Able to work in the company’s San Jose, California office at least 2-3 days/week.

Education and Experience

PhD, MD, MS/MA, or equivalent experience in a scientific or health-related field, and additional course work in management and in areas relevant to preclinical or clinical research or more than 7 years of experience in research and development, including direct technical management of projects, planning for personnel, and developing budgeting plans

Senior Regulatory Scientist

Senior Regulatory Scientist is a non-laboratory position with basic responsibilities including technical, scientific, and regulatory affairs tasks in support of CCS Associates (CCSA) consulting contracts, development and management of projects within a technical program, serving as a regulatory affairs expert on pharmaceutical agents and/or medical devices, and interaction with clients.

Responsibilities

Authors regulatory submissions documents for clients. May review work of other scientists in the company.
Develops necessary regulatory expertise, proposes regulatory strategies, and participates in responses to FDA comments.
Interprets complex, region-specific regulations e.g., US FDA, Health Canada and EU Competent Authorities.
Manages strategic and regulatory authorship components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, or BLAs.
Leads the planning, preparation, and conduct of regulatory authority meetings, and participates in discussions with regulatory authorities as appropriate.
Assesses and communicates potential regulatory risks and proposes mitigation strategies.
Develops and manages regulatory affairs projects as requested by the Director, Regulatory Science.
As appropriate, contributes to biomarker research as it relates to regulatory strategy.
As appropriate, participates in and documents the proceedings of meetings with clients, workshops, and conferences on regulatory strategies.
Interacts with both government and commercial clients and helps develop new business.
Contributes to new client contract proposals.
Works independently and may develop own projects.

Qualifications

Excellent written and oral communication skills; publications in peer-reviewed biomedical journals.
Experience in carrying out scientific and regulatory affairs projects.
Extensive scientific and technical background in biomedical sciences; skill in data analysis.
Ability to work independently or as part of a team.
Drug or assay development experience and expertise.

Education and Experience

PhD or MS in health-related science.
Three or more years’ relevant postgraduate experience at CCSA or in pharmaceutical or biotechnology industry or in an academic setting.

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