Sr. Clinical Trial Management Associate

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

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

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)