Clinical Trials Management Associate – II

Job description

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 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row) Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.