Clinical Data Associate

CLINICAL DATA ASSOCIATE

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our client is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet need and is seeking to add a Clinical Data Associate to their team in Foster City, CA.

 

JOB SUMMARY:

Works collaboratively with CRA, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for routine to basic clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of clinical data and data structure.

 

RESPONSIBILITIES:

- Assisting in the implementation of clinical data management process with CRO's including data entry, data quality checking, data transfer, reporting, backup, and recovery.

- Assists in the preparation of CRF/eCRF data collection through the regulatory approval process.

- Assists field clinical staff in collecting data to meet the protocol requirements in a timely manner.

- Identifies, tracks, and resolves basic queries.

- Utilizes reports to track study progress and ensure timeliness and quality expectations are met.

 

QUALIFICATIONS:

- Excellent verbal and written communication skills and interpersonal skills are required.

- Must understand relational database design, have knowledge of FDA regulations and be familiar with web-based Electronic Data Capture (EDC) and clinical data management systems.

- Must be able to effectively communicate and possess good problem solving as well as people/project leadership skills.

 

EDUCATION:

- BS degree in a Biomedical Science or equivalent and minimum 2 years of relevant experience in Clinical Data Management in a CRO or bio/pharmaceutical setting, or a MS degree and minimum 1 year of relevant experience.

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.