Overview
Phenomix Corporation offers tremendous opportunities at the leading edge of drug discovery research. Phenomix is a dynamic, start-up biotechnology company based in San Diego.
Phenomix is committed to excellence and seeks qualified and highly motivated team players who want to make an impact. Our compensation package is competitive, and we offer opportunities for career advancement. Phenomix is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, handicapping condition, marital status, or other protected status covered by applicable government regulations.
Contact HR
Phenomix is assembling a great team of people to make contributions
to the development of our company. If you are interested in joining us, please submit
your information to jobs@phenomix.com.
Job Listings
Overview:
The Clinical Research Associate assists with all operational activities within the clinical research department. S/he will work closely with the Clinical team as well as Research & Development, Regulatory, Contract Research Organizations (CROs), internal Project Managers and other outside consultants and contractors to assist with the effective design, execution and reporting of Phase I-III clinical studies. This position is accountable for consistent compliance with Good Clinical Practices, including management of CROs who may be assigned partial or complete clinical study activities during drug development. The individual in this position will work on projects in multiple therapeutic areas, both in the U.S. and overseas.
Summary of Key Responsibilities:
- Establish appropriate processes and procedures to conduct clinical trials, including support for clinical programs in Type 2 diabetes mellitus, Hepatitis C and possibly other indications.
- Plan resources and tasks to meet corporate goals for timely initiation and completion of clinical studies.
- Assist in establishing/implementing systems for tracking of various activities, processes and procedures during clinical trials, e.g., data warehousing, clinical reviews, data query resolution, drug supply, budgets etc.
- Interact with and supervise CROs.
- Assist in setting up, negotiating, planning and monitoring of budgets for clinical operations as needed.
- Collaborate with CROs in evaluating clinical study sites and coordinate and conduct site audit activities as necessary.
- Monitor or co-monitor clinical sites to ensure that the study is conducted in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements
- Track enrollment of clinical studies.
- Support the preparation of clinical sections of regulatory submissions.
- Help maintain appropriate Standard Operating Procedures (SOPs) for the department and assuring staff training (in collaboration with Regulatory).
- Respond to audits and data queries.
- Assist in reviewing and revising protocols as required.
- Develop, review and revise informed consent form templates as required.
- Develop study documents such eCRF templates and eCRF completion guidelines, study procedures manual, and develop and review source document templates.
- Other duties as assigned by the Senior Director, Clinical Operations
Required Skills, Knowledge, Abilities and Qualifications:
- Degree in science or science related area (minimum BA, preferred MS).
- Approximately 3-5 years of relevant industry experience supporting clinical programs (preferred therapeutic areas: metabolic, infectious disease).
- Ability to travel to clinical study locations: may require domestic travel up to 30% at peak times and some international travel as required by the project.
- Live in San Diego area.
- Prior success with oversight of CROs, hands on monitoring experience, and supporting clinical study sites and IRBs.
- Working knowledge of U.S. and ICH GCP regulatory requirements.
- Experience in early stage programs, late stage programs is a plus.
- Excellent written and verbal communication skills with attention to detail.
- Creative problem-solving and critical thinking skills.
- Prior experience in small company environment is a desired.
- Team player that operates easily in an informal but fast-paced biotech environment.
Overview:
Global Clinical Auditor independently performs or leads audits to assess quality and compliance with applicable GCP regulations. Communicates audit findings and recommendations for corrective actions and evaluates adequacy and completeness of corrective action plans. Reviews audit reports prior to issuance for accuracy and consistency as well as provide guidance to auditors in communicating findings and recommendations. Evaluates audit report findings for identification of trends. Participates in evaluation of effectiveness of the audit program applied to specific projects. Applies advanced technical skills in compliance with Good Clinical Practices related to clinical research. Participates in development of corporate written policies and procedures.
Summary of Key Responsibilities:
- Independently conducts audits of clinical trials, including worldwide clinical investigator audits, clinical vendor audits, internal audits, and other special audits and assessments as assigned. Communicates audit findings in writing to management and other responsible personnel. Recommends corrective and preventive actions. Tracks generation of corrective action plans and evaluates adequacy and completeness of corrective/preventive action plans.
- Manages consultant auditors and reviews audit reports prior to issuance for accuracy and consistency. Provides guidance to the auditors in communicating findings and recommendations. Evaluates audit findings for assessment of effectiveness of the quality and compliance program applied for specific projects and provides recommendations for increased effectiveness. Participates in evaluation of audit findings to identify compliance trends and system - related issues within client group projects for periodic communication to management.
- Participates in development of process improvement strategies and training on these strategies, as needed.
- Participates in development and training personnel in GCPs.
- Participates in development of written procedures and guidelines and associated training.
- Maintains required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations by participating in industry trainings, workshops and discussion groups. Serves as internal consultant in interpretations of regulations, standards and compliance issues, with minimal supervision.
Required Skills, Knowledge, Abilities and Qualifications:
- BA/BS degree in life sciences and 6 years relevant industry experience, with 4 years in GCP-regulated environment.
- Must be willing to travel approximately 50%.
- Excellent attention to detail
- Excellent written and verbal communication skills
- Thorough understanding of GCP regulations and their application to projects
*** Please - no inquiries or responses from recruiters.
