Responsibilities include, but are not limited to:

·        Operational responsibility, through a CRO, for aspects of clinical trial activity, including preparation of study protocol and CRF, budget negotiation, investigator selection, study initiation, monitoring, closeout, and report review;

·        Producing, maintaining and monitoring project, development budget plans and timelines;

·        Clinical trial supply ordering and tracking;

·        Working closely with data managers to ensure data retrieval and clean-up is on schedule;

·        Vendor selection and management:  CROs, central labs, clinical trial supply manufacturers and distributors;

·        Maintaining regular contact with personnel at clinical investigative sites and/or CROs;

·        Reviewing and providing input on all necessary study related documents, e.g., protocol, CRFs, informed consent, etc.;

·        Effectively liaising with all participating functional areas that are represented at the clinical trial team;

·        Coordinating and preparing training presentations and/or attending investigator meetings.

Requirements:

Applying candidates must have a Bachelor’s degree in a scientific discipline or the equivalent, with at least 4-6 years clinical research experience.  Three years of direct monitoring experience is preferred.

The ideal candidate possesses knowledge and appreciation of all stages of pharmaceutical drug development, analytical operations, compliance and documentation.  He/She must have demonstrated leadership skills with ability to work in high performance teams.  This position requires excellent knowledge of monitoring practices, demonstrated knowledge/competence in application of CFRs, GCPs, and ICH guidelines.  He/She must possess excellent oral and written communication skills, attention to detail, project management skills, superb organizational and interpersonal skills, and the ability to juggle multiple projects with strict timelines.