- 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
At least 3+ years of experience and a BS or BA in a relevant scientific discipline
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.
Thank you.
Kind Regards,
Harris Kaushik
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - (732)-844-8715
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
