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CAREERS
PSC Clinical is an established regulatory, compliance, quality assurance and validation company for clinical trials. PSC Clinical was incorporated in 1996, and is now an employee-owned company with offices in Pomona, CA, San Diego, CA, San Francisco, CA, Austin, TX, Singapore, Singapore, and Beijing, China. We presently have approximately 80 full time employees and approximately 20 subcontract employees. Our firm offers 100% health coverage for our employees, pay for every hour worked, a contributing 401 K, end of the year profit sharing and an equity stock program. This translates into a happy, productive, self-directing workforce that can consistently, reliably and reproducibly deliver quality results on projects with challenging, complex aspects.
PSC Clinical prides itself on providing excellent service at cost effective prices, setting it apart from many "Job Shops" and premium "High End" consulting firms. We only perform audits and other services for the Life Science industries, so we have developed a tremendous amount of expertise in these industries. We perform our work with the highest ethics and quality. We always keep in mind that whatever we do and how well we do it affects patients, the ultimate beneficiaries of our work.
PSC Clinical is currently seeking full-time Validation Engineering Interns to train in the exciting field of Validation. The internship is an opportunity to gain valuable experience and to develop highly sought-after skills. As the pharmaceutical, life science and medical device fields continue to grow, the need for validation and other compliance services continues to increase at a rapid rate.
Validation Intern duties will include the following:
- Writing technical documents, such as validation protocols
- Execution of validation protocols
- Calibration of various validation equipment
- Calculation and interpretation of data for validation testing
- Review and modification of Standard Operating Procedures (SOPs)
- Risk Assessments
Validation Intern requirements
Applicant must have graduated with an engineering or technical degree from a four-year college or university.
Knowlege of PC computer OS, knowledge of MS office suite mandatory
Must have strong verbal and written communication skills
Applicant will be working in a biotech/pharmaceutical environment as a consultant/contractor for various clients. He/she will be working directly with clients on numerous projects for various GMP facilities, GLP labs, and GCP clinical research to help clients with validation, compliance and regulatory affairs issues. Applicant must be willing to learn new ideas, techniques and systems and actively pursue knowledge and growth. Applicant must also be flexible and able to travel to client sites.
PSC Clinical is looking for GCP Auditors. The GCP Auditors will work on a tem of auditors under the direction of the VP of Clinical Operations to provide superior auditing services for Phase 3 Pivotal Trials around the World. Full or Part-time, Permanent or Contract positions are available.
Responsibilities:
Prepare and perform GCP Audits
Report all audit observations
Serve on project teams
Review clinical documentation
Assist in the management of information between customer sites being audited and PSC Clinical
Provide excellent customer service to promote professional relationships with customer sites
Requirements:
Education:
Medical Background Preferred
Bachelor of Science, RN, MD, or equivalent from an accredited school required.
Experience:
2-5 years of experience with GCP guidelines
A minimum of 1-2 years in auditing of clinical trials
Professional Skills:
Strong interpersonal and communication skills
Willingness and ability to travel
Firm grasp on articulation of ideas efficiently and positively
In-depth knowledge of the industry dynamics and current developments
Clinical Regulatory Specialist
The Clinical Regulatory Specialist is responsible for maintaining company compliance with all federal and state regulations that govern the industry and insuring the quality of clinical trial research.
Responsibilities
Developing reports for the Data and Safety Monitoring Board.
Establishing and maintaining human subject protection assurances.
Prepare, review, revise, and submit FDA applications and required documents for an IND and NDA.
Maintenance of compliance with all applicable federal regulations, such as the HIPPA privacy rule.
Provide consulting on regulatory issues in regards to patient safety, adverse events, and serious adverse events.
Staying up-to-date on clinical trials and human subject protection regulations.
assisting in maintaining and/or developing compliant procedures for new initiatives.
Requirements
Bachelor's Degree in either a Science or Technical discipline.
3+ years of regulatory experience within the pharmaceutical industry.
Regulatory Affairs certifications recommended.
Strong written and verbal communication skills necessary.
Attention to detail and the ability to see a project through to completion.
Basic knowledge of Microsoft Office applications required.
Strong knowledge of FDA regulatory requirements.
To inquiry or submit your resume, contact Janel Wang at 512-586-1473 or email jwang@pscclinical.com
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