Job Information
ICONMA, LLC Clinical Trials Management Associate in United States
Our Client, a Biopharmaceutical company, is looking for a Clinical Trials Management Associate for their Santa Monica, CA location. Responsibilities:
Monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
Requirements:
Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas. Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
May assist in compilation of investigator brochures under close supervision.
May resolve routine monitoring issues. Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
Excellent verbal, written, interpersonal and presentation skills are required.
Must be familiar with routine medical/scientific terminology.
Must be familiar with Word, PowerPoint, and Excel.
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
Must be able to contribute to SOP development.
Why Should You Apply?
Health Benefits
Referral Program
Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.