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Clinical Quality Assurance Specialist

Headhunters, LLC
Gaithersburg, Maryland, United States
February 04, 2019


Headhunters, LLC's client is seeking a Clinical Quality Assurance Specialist for their Gaithersburg location.

This position will be responsible for verification and auditing of data generated during the conduct of a clinical study. This position maintains Quality Systems and infrastructure appropriate for product development in compliance with Good Clinical Practice (GCP) requirements. Individual will support the Quality requirements for the conduct of clinical trials, ensuring the realization of industry best practices for GCP activities. This position interacts and influences in support of project team decisions. This position requires knowledge around clinical study conduct, including excellent and timely cross-functional communication and technical writing skills. This position requires some knowledge of medical devices, pharmaceutical and biological clinical Phase I-IV trials. This position ensures the successful and timely support of clinical studies through documentation review, quality auditing, compliance advice, and implementation of Clinical QA oversight processes. This position will serve as the Quality support point of contact for clinical research studies.


• Qualified candidate will be responsible for verification and auditing of data generated during the conduct of a clinical study ensuring compliance with standard operating procedures, regulatory requirements, and U.S. Government clients’ specifications.

• Responsibilities will include review of data to verify tables and listings, content of all key study documents and all other clinical relevant documentation required for regulatory submissions, manuscripts, etc.

• Role will also provide Clinical Quality support activities and updates for presentations and program status to government funded agencies on a routine basis.

• Will support a broad range of complex problems relating to the clinical trials by fostering effective interdepartmental and cross functional partnerships

• Review changes to global regulatory requirements and industry best practices and facilitate implementation through new and/or revised processes

• Develop Quality Agreements with vendors performing GCP activities

• Will provide guidance and content for Clinical Quality Oversight requirements, and activities in clinical key study documents, as needed.

• Will assist with the development and implementation of a Clinical Quality Oversight program to include clear processes and procedures for executing appropriate quality support during clinical trials.

• Assist with providing FDA, EMA, and ICH guidance to support project teams in maintaining compliance and awareness in preparation for agency inspections

• Develop audit schedules and conduct global GCP audits including Part 11, Clinical and Pre-Clinical Data Management/Stats, clinical and non-clinical trial audits

• Ensure visibility to and review of clinical trial deviations to ensure appropriate investigation has been conducted, documented and corrective measures implemented to prevent future occurrences.

• Support coordination and management of GCP-related inspections by Regulatory Authorities, including pre-inspection activities, BIMO inspections, and follow-up activities. Actively support for-cause activities.

• Ensure the Clinical Operations team are compliant with procedures and CROs are compliant with clinical key study documents and agreements prior to and during study conduct.

Education, Experience & Skills

• The candidate will have a Bachelor’s Degree in Biology or related field with at least 2-4 years of experience with QC review of clinical study data, including experience with reviewing SAS datasets, clinical study reports (CSR), Case Report Forms (CRF), and data listings in the biopharmaceutical, pharmaceutical or medical device industry. Statistical analysis understanding a plus.

• Must have experience and understanding of QC operations and Quality Systems, including familiarity with GCP regulations and guidance documents, as well as strong technical, communication (verbal and written), and computer (MS Office, graphics/statistical software) skills.

• The ideal candidate will exhibit superior attention to detail, excellent organizational skills including strong multi-tasking abilities and ability to adapt to shifting priorities, as well as experience in working within a fast-paced, team-oriented environment.

• Has broad expertise or unique knowledge, uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

• Creates formal networks involving coordination among groups.

• Support the activities of others and/or other departments.

• Will support highly complex and unique issues where analysis of situations or data requires an evaluation of intangibles.

• Can operate independently and able to identify observations and/or gaps in clinical relevant areas.