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.*

Drug Safety Associate II

Summary

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

Duties and Responsibilities

  • Processes AE and SAE data from both clinical research and post-marketing settings.
  • Works with other department members and data management staff, ensures acquisition of appropriate information and facilitates assessment and timely reporting of AEs and SAEs, including expedited and annual reporting.
  • Performs triage of SAEs to determine regulatory reporting requirements; contacts investigators, site coordinators, and medical monitors to solicit comprehensive information about reported AEs and SAEs. Coordinates relevant follow-up information.
  • Enters cases into the safety database, writes case summaries and queries.
  • Reviews literature (including Investigator’s Brochures) on clinical and preclinical studies to provide context for all reported SAEs, updating safety sections of Investigator’s Brochures, preparing safety reports for review and for filing by Regulatory Affairs with the Food and Drug Administration and other appropriate agencies, and participating in reconciliation between clinical trial and safety databases.
  • Coordinates and facilitates the review of SAEs by the Drug Safety Physicians to assure timely assessment of cases.
  • Supports pharmacovigilance management, in all aspects of project management for clients.
  • Builds and maintains good relationships across functional units and company affiliates.
  • Generates MedWatch, CIOMS II, and standard listings from applicable safety databases.
  • Assists the Drug Safety Operations Senior Manager and Drug Safety Physicians in communicating with corporate partners regarding safety issues, coordinates and oversees notification of investigators and Institutional Review Boards of safety reports, responds to inquiries for safety information, prepares periodic safety reports, develops and maintains procedures and systems for processing SAEs within appropriate timeframes for each client, and assures that company standard operating procedures (SOPs) governing safety data management are appropriate and personnel are trained accordingly.
  • Participates in safety related education programs for internal and site personnel and participates in writing safety sections of clinical protocols and case report forms.
  • Makes decisions with input from Drug Safety Operations Senior Manager.

Qualifications

  • Familiar with word processing and database software for Windows-based computer operating systems.
  • Familiar with MedDRA, COSTART, and WHODRUG terminology; knowledge of other medical vocabularies such as SNOMED is a plus.
  • Excellent written and verbal communication skills, organizational skills, and attention to detail.
  • Requires strong analytical abilities and ability to work effectively and flexibly with other staff and clients, as well as to work independently to accomplish objectives within timelines established by the regulations.
  • Familiar with FDA and ICH guidelines for SAE reporting.
  • Experienced with pharmacovigilance, AE reporting systems (e.g., Argus™, Oracle AERS™), and direct interaction with study investigators and medical monitors.
  • Experienced in oncology, chronic inflammatory disease, or cardiovascular disease.

Education and Work Experience

  • BS required.
  • 4 years’ experience in safety data management in pharmaceutical or biotechnology research and development (in industry or clinical research organization [CRO] setting).
  • 4 years in drug safety operations, or equivalent.

 

Drug Safety Physician/Scientist

Summary

Drug Safety Physician/Scientist primary responsibilities include review and evaluation of serious adverse event (SAE) reports within sponsor, pharmaceutical company, and regulatory timeframes, assist in establishing reporting policies and procedures, 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.

Duties and Responsibilities

  • Develops and maintains procedures and systems for processing SAE reports within appropriate timeframe for client needs.
  • Evaluates all SAE reports and other safety reports as applicable for completeness, accuracy, medical information, adherence to safety and regulatory standards, and reportability to regulatory authorities.
  • Writes detailed and concise narratives for SAE reports.
  • 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.
  • Works closely with Drug Safety Operations group on all safety reporting activities.
  • 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 Drug Safety Operations and Regulatory Affairs staff to ensure timely Investigational New Drug (IND) safety reporting.
  • Provides site management and monitoring support for sponsored clinical studies.
  • Educates and trains site and study staff in managing sponsored studies, including regulatory and International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) compliance.
  • Makes decisions with input from Senior Director, Clinical Research and Regulatory Affairs (safety) or Senior Director, Research and Development (monitoring) as needed.

Qualifications

  • Experience with database software and Microsoft Word and Excel.
  • 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, exceptional organizational skills, ability to work independently or in a team environment.

Education and Work Experience

  • MD or RN (MSN preferred).
  • Minimum of two years in safety data management in clinical safety and/or clinical research, in pharmaceutical or biotechnology research and development (industry or clinical research organization [CRO] setting).

 

Manager, Quality Assurance & Compliance

Summary

Manager, Quality Assurance and Compliance (MQAC) contributes to the design, implementation and maintenance of a QA system for CCSA. This system supports both internal CCSA needs and ensures compliance with clients’ projects requirements. These projects encompass a variety of services to government, academic, and commercial clients including statistical design of clinical trials and research studies, data management, data analysis and reporting, regulatory affairs, site monitoring, safety/medical monitoring, document management, and site and vendor management. The MQAC implements corporate QA processes for standard operating procedures (SOPs), staff training, and corrective/preventative actions within the context of the projects, as well as contributes to the development of specific QA programs that address the needs of each client. The MQAC will develop a system for the projects to define and track relevant performance, quality, and risk metrics. The MQAC will interact with the CCSA departments, project managers and other staff to accomplish the objectives of the QA system. The MQAC reports to the President, CEO within the Executive Office and works closely with the President, CEO, making observations, findings and recommendations for process improvement and targeted training.

Duties and Responsibilities

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Knowledgeable of and stays up-to-date with industry and regulatory agency quality regulations.
  • Serve as a QA resource providing QA technical guidance recommendations to departments; Provides GCP QA expertise and leadership.
  • Develops and maintains QA programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
  • Participates, develops, and implements SOPs to ensure CCSA’s Quality Management Programs compliance. Updates and implements changes as required.
  • Oversees quality control review of regulatory documents and processes.
  • Adheres to regulatory submission processes in accordance with required company/project guidelines.
  • Leads compliance audits as required.
  • Works with stakeholders to ensure that audits are conducted on a continuing basis to enforce company and client requirements.
  • Ensures compliance with current GxP (particularly GLP and GCP) practices. Maintains International Conference on Harmonization (ICH)/Good Clinical Practice (GCP)/Good Laboratory Practice (GLP) audits. Working knowledge of 21 CFR Parts 11 and 58 as part of product development processes.
  • Manages and monitors corrective action plans.
  • Works with the internal stakeholders to ensure appropriate and timely response and follow-up on QAC matters.
  • Develops and maintains manual of operations (MOP) using company/client standards and requirements.
  • Provides training in quality and reliability procedures, as needed, and acts as a resource to ensure QC.
  • Develops and oversees on-site audit visits in accordance with clients’ requirements.
  • Makes decisions independently with input from department directors, President, CEO and others in the Executive Office.

Qualifications

  • Demonstrates excellent verbal, written and interpersonal communication skills.
  • Demonstrates knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, and performance measures and quality improvement.
  • Certification by ASQ (Certified Quality Auditor, Certified Quality Manager) or other industry-recognized professional organizations is a plus.
  • Ability to work with cross functional groups and handle difficult people/situations under pressure.
  • Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees.
  • Ability to deal with competing timelines.
  • Ability to work independently and as part of a team.
  • Ability to prioritize work and handle multiple assignments.
  • Excellent decision-making skills to manage workload.
  • ≥5 years’ experience as Senior QA Specialist or in comparable position in relevant work setting.

Education and Work Experience

  • BA or BS in biological sciences, chemistry, or related field.

 

Research Associate I

Duties and Responsibilities

  • Provide organizational support to the Regulatory Affairs department under the direction of the Regulatory Operations Manager.
  • Assist with regulatory document review and processing (input data, coordinate, track, quality-check and file regulatory documents in electronic and hard copy format in accordance with corporate documentation procedures, ensuring the timely completion, distribution, and archiving of the documents).
  • Utilize current electronic publishing and document management technologies as well as traditional (paper) document production/filing methods and equipment.
  • Responsible for organizing, compiling, publishing draft regulatory submissions in electronic format, including initial IND applications, and maintaining the lifecycle of the application.
  • Assist with drafting IND meeting agenda, compiling related materials, following up with issues discussed during the meetings.
  • Responsible for tracking protocols and related documents in tracking database, and preparing reports from database for contractual deliverables.
  • Contribute to design and revisions of databases for regulatory documentation.
  • Assist in creation and revision of SOPs under the regulatory umbrella.
  • Assist with creation and maintenance of monthly ISPY2 DSMB reports.
  • Attend monthly IND meetings and other department meetings as scheduled.
  • Approximately 40% data entry, 25% word processing, 25% administrative, and 10% filing.
  • Adapts to timeline or priority changes by reorganizing daily workload.
  • Other assignments related to the job function as requested by supervisor.
  • Make decisions with guidance from the Regulatory Operations Manager and other team members.

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 and heavy data entry experience; experience with Adobe Acrobat and MS Access.
  • Resourceful, ability to resolve issues, solutions-oriented.

Education and Work Experience

  • BA/MA/MS.
  • Previous experience, or certification in a health-related field, such as medical technology.
  • One to four years’ experience in regulatory affairs, or one to two years’ experience plus RAC certification.
*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.