Clinical stage biotech company in Gaithersburg, MD who focuses on biologics to treat cancers and autoimmune disorders. The Company is progressing from a clinical-stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility, and commercial capability.

They are looking for a Clinical Research Associate in the local area to join their clinical team.

Responsibilities include but are not limited to:

• Oversees TMF set-up, maintenance, and quality control checks for assigned studies

• Maintains CTMS entry for assigned studies

• Assists Clinical Project Manager with study tasks including Site ID, Vendor ID, Vendor oversight, site payments, budget, and financial management.

• Prepares and attends project team meetings and provides updates on project status and site-specific performance.

• Oversees study start-up and site management for assigned studies. Identifies areas requiring follow-up and improvement at each clinical study site and recommends and implements corrective action.

• Assists in preparation for advisory board and investigator meetings and training materials; presents or assists in presentation.

Qualifications:

• Life sciences or medical background is required.
• At least 3 years experience in a function that can be related to pharmaceutical or medical development, preferred previous CTA or CRA experience
• Bachelors Degree
• The ability to work with cross-functional teams in a matrix environment is a must.
• Strong organizational and time management skills; detailed oriented.
• Excellent interpersonal and communication skills
• Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project.
• Ability travel domestically globally up to 20 - 30% of time.