Sr. Clinical Trial Management Associate

Title: Sr. Clinical Trials Management Associate

Duration: 6 Months

Location: Foster City, CA, United States

JOB RESPONSIBLITIES AND SKILLS

• Must meet all requirements for CTMA position and have demonstrated proficiency in all relevant areas
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
• Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
• Must have a general understanding of functional issues and routine project goals from an organizational perspective
• May participate in abstract presentations, oral presentations and manuscript development.
• Interfaces with individuals in other functional areas to address routine study issues
• Ability to develop tools and processes that increase measured efficiencies of the project
• May be asked to assist in the training of CTMAs and CPAs
• Assists in CRO or vendor selection
• Coordinates CROs or vendors
• Assists in the setting and updating of study timelines
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
• May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required
• Assures site compliance with the protocol and regulatory requirements
• Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
• Excellent verbal, written, interpersonal and presentation skills are required
• Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
• Working knowledge and experience with Word, PowerPoint and Excel

MINIMUM EDUCATION AND EXPERIENCE

At least 3+ years of experience and a BS or BA in a relevant scientific discipline

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

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