Description
Clinical Compliance SpecialistA pharmaceutical company in the Palo Alto, CA area is looking for a Clinical Compliance Specialist to join their team. This is an excellent opportunity to join a start-up with an exciting pipeline.
Clinical Compliance Specialist Overview:
Provides critical direction, documentation, deliverables, assistance and support for all quality control compliance functions related to Good Clinical Practice (GCP) for clinical development activities. Ensure high level GCP compliance, documentation and adherence to company's and external partners SOPs. The position requires a strong working knowledge of FDA regulations and guidance documents, International Conference on Harmonization guidelines and cGCP guidelines. Through proactive and comprehensive compliance initiatives directed by the Clinical Compliance Specialist, the company's clinical development activities will be conducted at a very high level consistent with GCPs with robust documentation to provide confidence and assurance in all clinical data and results generated.
The Clinical Compliance Specialist will have the following responsibilities and roles:
- Clinical SOPs, processes -development, revision, training and implementation of required SOPs
- Oversight and accountability for compliance within the Clinical Department with internal SOPs, process, and regulatory requirements by:
- Identifying process gaps
- Performing internal process assessments of clinical operations and or documentation
- Effectively documenting process improvements to demonstrate due diligence with proactive compliance
- Identifying the critical components to achieving increased clinical compliance through a risk-based approach
- Identify and development of specific tools, critical documents needed to track compliance, and processes to enable proactive and systematic detection, analysis, remediation and prevention of compliance quality issues/risks
- Identifying useful indicators for assessing compliance for ongoing performance of clinical vendors
- Evaluating performance indicators tracked to ensure GCP compliance is maintained and to alert management of potential non-compliances
- Effective strategies for tracking and recording changes to study documentation
- Participate in end of study documentation compliance reviews including data set review, Tables, Listings and Findings, CSR, Trial Master File reconciliation
- Serve as Clinical interface with Topica's Quality Assurance Group for all GCP internal and external audits and CAPA.
- Some travel may be required to key clinical vendor sites and clinical research sites.
Clinical Compliance Specialist Requirements:
- Minimum BS or equivalent and minimum 10 years clinical research experience in a pharmaceutical/biotech company working within clinical compliance, process improvement, and/or risk management
- Proven ability to work independently, efficiently and effectively
- Effective communication and time management skills critical to achievement of QC goals;
- Good working knowledge of clinical development software (IWRS, Rave, MS Office etc.);
- Familiarity with an outsourced clinical trial model;
- Ability to represent Topica effectively with CRO and key external vendors, and;
- Excellent documentation skills and systems design.
If you are interested in this position, please respond to this job positing ASAP.
To find out more about Real please visit www.realstaffing.com