Clinical Contracts Associate II
Proclinical is currently recruiting for a Clinical Contracts Associate II position in the South San Francisco, CA area with a leading pharmaceutical company.
- Collaborate with other teams for the planning, development, and implementation of standards, processes, and projects to ensure the effective and efficient archiving of clinical agreements and related information created in support of clinical research.
- Comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.
- Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements.
- File incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filing.
- Ensure record filing is kept up to date and is performed accurately by DMT members.
- Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents.
- Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying records.
- Track and maintain departmental metrics related to operational activities, progress of contract filing and archive, quality measurements and other variables.
- Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival.
- Ensure appropriate documentation completed to track archival of files.
- Provide management with DMT metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level of outstanding items on a periodic and/or ad hoc basis as requested by management.
Skills and Requirements:
- BA/BS required.
- 3-4+ years' project or clinical trial coordination/management experience.
- 3+ years' Clinical Research Associate (CRA) or relevant records management.
- TMF experience preferred.
- Exemplary interpersonal skills with proven demonstration.
- Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management.
- Proficiency in MS Project and standard desktop tools including, but not limited to, MSWord, Access, PowerPoint, Visio, and Excel.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.