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.*

Application Developer I (Entry Level)

Summary

Application Developer I assists in designing, developing, and implementing (MS) Access, Postgres, and Oracle databases for internal and external customer projects. Assists on-going maintenance and enhancement of existing and newly developed systems and web applications. Able to assess end-user requirements and translate them into database features. Implement data models using open source as well as vendor proprietary tools. Assists implementing and maintaining security (e.g., adding/deleting users and limiting user access) for systems.

Duties and Responsibilities

  • Produce web-based reporting tools (i.e., dashboards) for user tracking.
  • Responsible for understanding end-user requirements in order to create functional and design specifications for database development.
  • Uses functional and design specifications to develop databases.
  • Assists in developing and testing appropriate data consistency, data cleaning, and data derivation programs, using Java, Visual Basic, C++, PHP, PL/SQL, PostgreSQL. Creates appropriate documentation for each system implemented.
  • Produce documentation (technical specifications, user guides, etc) and other deliverables that meet customer’s requirements.
  • Develops reports and data consistency and cleaning checks for each database.
  • Develops, tests, and implements data loading scripts for medical and drug thesauri as well as data consistency checking for batch data loads.
  • Participate into other cross-function design, development activities.

Qualifications

  • Proven software programming skills using Visual Basic, Java, JSP, PHP, PL/SQL, JavaScript, HTML, and CSS.
  • Proficient with MS Access, Visual Basic, and SQL.
  • Familiarity with application servers (Tomcat, Apache).
  • Understands and adheres to company and/or industry standard coding practices. Self-starter who stays on top of changing needs and takes direction well.
  • Proven relational database design skills.
  • Ability to review and understand technical specifications and system documentation.
  • Ability to understand requirements and translate them into functional and design specifications.
  • Ability to adhere to SOPs and guideline.
  • Ability to work well independently or as part of a team, and under pressure.
  • Excellent communication and problem-solving skills.

Education and Work Experience

  • BS in Computer Science/IT or equivalent and two to five years relevant experience.
  • Requires one to three years MS Access, PostgreSQL, MySQL database programming experience.
  • Requires one to three years with PHP, JavaScript.
  • Experience with Java, JSP, Oracle database a plus.
  • Familiarity with clinical data, clinical data management systems (Openclinica), Clinical Report Forms (CRF) a plus

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.

Drug Safety Associate

Summary

Drug Safety Associate primary responsibilities include processing and tracking of initial and follow-up serious adverse event (SAE) reports to completion; communication of SAE reports to sponsor and partners, medical monitors, and investigative sites; and maintenance of electronic and hard copy SAE case files.

Duties and Responsibilities

  • Receive and track SAE reports and supporting documentation in the SAE tracking database.
  • Provide background information on previous SAE reports to support evaluation by Drug Safety Physician or Drug Safety Associate.
  • Maintain system for follow-up of SAE reports and documentation.
  • Coordinate and manage distribution of SAE reports and supporting documentation internally to Drug Safety Physicians and externally to the sponsor, sites, and pharma partners.
  • As requested, enter data into the appropriate SAE database for a specific study, including batch validation and discrepancy report generation.
  • Assist in projects for sponsor as requested by Drug Safety Operations Manager or Senior Director (e.g., quality assurance (QA) of regulatory document collection).
  • Assist in workflow and problem-solving.
  • Prepare line listings for Investigational New Drug (IND) annual reports and other ad hoc
  • Prepare AE/SAE reconciliations for sponsor and pharma partners.
  • Perform active follow-up and query management, including both written and verbal communication with healthcare professionals, medical monitors, and clinical sites.
  • Work closely with Regulatory Affairs Manager for timely submission of IND safety reports.
  • Request listings of similar events from Data Management, for the analysis of similar events.
  • Perform data entry and quality check of external safety reports.
  • Generate MedWatch, CIOMS II, and other standard listings from applicable safety databases.
  • Assist in projects for clients as requested by Drug Safety Operations Manager.
  • Knowledge of statutes, regulations, and guidances applicable to US and international serious adverse event reporting and regulatory affairs.
  • Work closely with Drug Safety Physicians, Drug Safety Associates, and Drug Safety Operations Manager.
  • Decision making with input from Drug Safety Operations Manager.

Qualifications

  • Proficient in database software, such as Access.
  • Highly organized, efficient, and detail-oriented.
  • Excellent interpersonal skills.
  • Familiarity with medical terminology.

Education and Work Experience

  • BS required; 1–3 years experience or certification in a health-related field such as medical technology preferred.

Regional Clinical Research Associate (East)

Summary

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. Assists in standard operating procedure (SOP) preparation and training as needed.

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 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 Work 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 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.