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.*

Clinical Data Associate I

Summary

Clinical Data Associate I is responsible for data management of assigned studies in compliance with departmental and customer Standard Operating Procedures (SOPs) and Guidelines. Interfaces with in-house Clinical Research Associates (CRAs), Agent Project Managers, and Quality Assurance personnel as well as customer site staff to resolve data discrepancies. Reviews customer protocols, CRFs, and data points for data management inconsistencies and design issues. Configures, validates, and uses off-the-shelf and custom systems to manage clinical data. Provides soft/hard copy listings and reports per client data management requirements.

Duties and Responsibilities

  • Reviews customer protocols for data management issues.
  • Create and test study data collection modules (g., CRFs, databases, etc.) using company/client standard systems.
  • Create study data collection module guidelines.
  • Review and validate data verification and cleaning scripts in company/client databases.
  • Enter study data into appropriate corporate/client databases.
  • Design, build, and conduct Quality Control checks against data.
  • Execute and review the results of data verification and cleaning scripts.
  • Review, query, and resolve outstanding data entry issues.
  • Track receipt and routing of study data and resolve missing data.
  • Work with CRAs and site coordinators on study data issues.
  • Develop and implement customer-defined study closeout procedures.
  • Review and validate lab specific data collection modules and validation scripts.
  • Scan documents into central repository and create and maintain hard-copy, study workbooks.
  • Assist in the development of data standards for IT and Data Management department.
  • Decision making with input from Sr. Manager, Data Management and Sr. Director IT/Data Management.

Qualifications

  • Proven understanding of databases as well as data collection, entry, and management.
  • Proven ability to design data collection modules and document data management processes.
  • Proven ability to adhere to SOPs and guidelines
  • Proven ability to work well independently (self-starter) and as part of a team in a small business environment
  • Proven ability to take direction and execute accordingly.
  • Proven ability to effectively communicate internally and to external study-related personnel.
  • Excellent organizational, communication, and problem-solving skills.
  • Must be able to review and understand medical/technical data.

Education and Work Experience

  • BA/BS in related field.
  • Comfort with PC, Windows OS, and MS Office suite a must.
  • Minimum 3 years of experience with data collection and management.

Senior Scientist – Immunology, Clinical Research

Summary

Senior Scientist – Immunology, Clinical Research is a non-laboratory position for scientist with immunology background; responsibilities include technical and scientific tasks in support of our consulting contracts; development and management of projects within a technical program; serving as scientific resource and pharmaceutical agent and/or medical device expert; and interaction with clients.

Duties and Responsibilities

  • Serves as pharmaceutical/biologics agent and/or medical device (imaging, molecular profiling) expert; surveys literature and reviews 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, for clients and regulatory authorities.
  • Contributes to design of databases of scientific and drug development information.
  • As appropriate, contributes to biomarker research.
  • 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.
  • Develops necessary regulatory expertise, proposes regulatory strategies, and participates in response to FDA comments.
  • Work independently and may develop own projects.
  • May supervise project area and staff.

Qualifications

  • Strong background in immunology, including experience with the development of therapeutic immune modulators, immune-oncology, and/or vaccines.
  • Excellent written and oral communication skills; publications in peer-reviewed biomedical journals.
  • Experience managing scientific projects and working in a team environment.
  • Extensive scientific and technical background in biomedical sciences; skill in data analysis.
  • Ability to work effectively without supervision.
  • Biochemist, molecular biologist, or toxicologist with drug development experience and/or expertise in animal and clinical pharmacokinetics and pharmacodynamics, with emphasis on immunology-based programs.

Education and Work Experience

  • PhD, DVM, or MD.
  • Two 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 immunology in areas relevant to program, such as pharmacology, molecular biology, toxicology, medicinal chemistry; experience in drug development preferred.
*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.