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.

Research Associate I, Clinical Operations

Research Associate I, Clinical Operations is responsible for receiving, performing quality checks, tracking, and filing of essential regulatory documents for clinical studies; communicating with clinical sites for document collection and monitoring visits; and reviewing site study documents. Responsibilities

Manages regulatory document processing (inputs data, tracks, quality-checks, and files regulatory documents in electronic and hard copy format in accordance with corporate documentation procedures, ensuring their timely completion, distribution, and archiving), and ensures documents are audit-ready.
Contributes to regulatory start-up activities, overseeing multiple clinical studies with responsibility for the coordination of resources and timelines.
Provides regular updates to management team and internal and external partners concerning status and progress of clinical studies.
Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs; monitors performance and escalates issues where appropriate.
Uses current electronic publishing and document management technologies, including electronic Trial Master File systems, as well as traditional (paper) document production/filing methods and equipment.
Participates in planning QA activities and coordinates resolution of audit findings.
Reviews site study documents (Informed Consent template and study tools/worksheets).
Adapts to timeline or priority changes by reorganizing daily workloads.
Performs other assignments related to the job function as requested by supervisor.
Limited decision making and only with prior input from the Senior Manager, Clinical Operations.
Approximately 40% data entry, 35% administrative, and 25% word processing.

Qualifications

Excellent organizational, planning, and follow-up skills.
Excellent communication, teamwork, and interpersonal skills.
Efficient, detail-oriented, flexible, self-starting, and able to meet tight deadlines.
Excellent computer skills, including Microsoft Office programs, and extensive data entry experience.
Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.

Education and Experience

BA/BS required; MA/MS preferred; preferably in a science or health-related field.
1–3 years of experience.
Experience in regulatory affairs or clinical operations preferred.

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 Scientist and Group Leader, Clinical Research

Senior Scientist and Group Leader, Clinical Research is a non-laboratory position with basic responsibilities including technical and scientific tasks in support of CCS Associates consulting contracts; development and management of projects within a technical program; supervision of technical and scientific staff with the group; serves as scientific resource and pharmaceutical agent and/or medical device expert; provides nonclinical and clinical guidance and project management; and interacts with clients.

Responsibilities

Serves as subject matter expert in pharmacology, pharmacokinetics, or toxicology to support and advise on nonclinical development of consulting contracts.
Provides scientific oversight for IND submissions, working with agent project managers on nonclinical and clinical rationale, content, and organization.
Provides project management support for IND submissions.
Provides scientific oversight and review of preclinical and clinical information and document requests from government and/or commercial clients.
Supervises scientific staff responsible for generation of regulatory documents; supervises additional scientific staff contributing to regulatory submissions.
Develops necessary regulatory expertise, proposes regulatory strategies, and participates in response to FDA comments.
Serves as pharmaceutical/biologics agent and/or medical device (imaging, molecular profiling) expert; survey literature and review client reports to stay current on agent/device.
Prepares documents for clients, such as manuscripts/reports, Clinical Development Plans, Investigational New Drug (IND) applications and other regulatory submissions, Investigator’s Brochures, and protocol reviews.
Prepares documentation requiring knowledge of pharmacology, pharmacokinetics, toxicology, or other specialized areas.
Contributes to design of databases of scientific and drug development information.
Interacts with government and/or commercial clients and may develop new business.
Facilitates scientific meetings and programs as requested by clients.
Contributes to new client contract proposals.
Develops and manages projects in area of scientific expertise
Works independently and may develop own projects.
Supervises project area and staff.

Qualifications

Excellent written and oral communication skills; publications in peer-reviewed biomedical journals.
Experience managing scientific projects and working in a team environment.
Experience mentoring and managing technical and scientific staff.
Extensive scientific and technical background in biomedical sciences; skill in data analysis.
Ability to work effectively without supervision.
Toxicologist, biochemist, or molecular biologist with drug development experience and expertise in animal and clinical pharmacokinetics and pharmacodynamics.
Located near enough to San Jose, California or Tysons Corner, Virginia to work in CCSA offices at least 2 days/week, and preferably 3–5 days/week.

Education and Experience

PhD, DVM, or MD.
Ten or more 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, such as pharmacology, toxicology, medicinal chemistry, molecular biology, along with experience in drug development.

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