Clinical Project Associate
Proclinical is currently recruiting for a Clinical Project Associate with a pharmaceutical company located in San Mateo, CA.
- Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
- Provide input and assist with harmonization of Clinical Operations databases and tracking tools.
- Assist in maintaining clinical information in the clinical trials management system (CTMS).
- Order and maintain inventory of clinical supplies such as Lab Kits or electronic diaries.
- Assists with development of country and/or site documents, including but not limited to, Informed Consent Form development and review.
- May provide verbal and written communication with study personnel.
- Under close supervision reviews and participates in the quality assurance of data through data listing review or document quality control in the eTMF.
- Arranges meeting logistics. Drafts meeting agendas and meeting minutes.
- Interacts with other departments, as directed, to complete assigned tasks.
Skills and Requirements:
- Certificate in Clinical Trial Design and Management, or equivalent is a plus.
- Knowledge of FDA regulations, ICH guidelines, and GCPs.
- Must have experience with MS Office.
- Experience with Adobe publisher preferred.
- Experience with preparation of study documents, eTMF, Medidata RAVE EDC system, eCOA, Central Labs and/or data listing review experience preferred.
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
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.