Responsibilities:
*Setting up, documenting and communicating project specific medical monitoring requirements for assigned projects.
*Supporting medical monitors under medical guidance in the conduct of studies
*Developing and reviewing medical monitoring and other study related plans
*Training project team and sites in the protocols
*Reviewing site and project team queries
*Reviewing medical data including labs, patient profiles, CRF data and eligibility/enrolment reviews
oPerforms scientific research for and provides input into the RFP
*Conducting medical data review and generates data queries
*Ensuring compliance with and adherence to all internationally recognized standards
*Initiating medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements
*Reviewing budget and scope of medical team's responsibilities addressing inadequacies or concerns with the Medical Director and/or project management team
*Tracking study progress, proactively resolves issues, and proposing corrective action to project team/clients
*Processing and addressing protocol non-compliances at Investigative sites and ensuring adherence to ethical guidelines
*Collaborating with Medical Directors on the medical-operational aspects of complex clinical studies
*Attending Investigator Meetings and interacting with Investigative site staff and client representatives
*Preparing for audits and inspections by sponsors or regulatory agencies
*Reviewing and QCing documents and work of other associates, as needed
*Mentoring other more junior members of the team
*Supporting PV activities as needed
EDUCATION AND EXPERIENCE
*Graduate in medicine
*Ideally, previous clinical practice experience in Gastroenterology, (Board certification or equivalent not required).
*CRO experience is preferred
*Knowledge of ICH / GCP regulations
*Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
*Fluent verbal and written English as well as SPANISH
*Excellent team player, collaborative and able to build an effective team
*Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
*Excellent organizational and time-management skills, able to prioritize workload to meet deadlines
*customer service focused in approach to work both internally and externally
*Maintains a positive, results orientated work environment
