Description
Duties:* Conducts and/or oversees all aspects required for selecting, initiating, monitoring and closing investigational sites in accordance with all applicable SOPs and GCP/ICH requirements.
* Serves as a primary contact for internal study team members and external vendors and clinical sites.
* Provides oversight of Clinical Research Organization (CRO) interactions in the areas of study/project management, monitoring, site management, trial master files, and data management.
* Assists in the preparation of clinical trial documents, including study protocols, amendments, model ICFs, laboratory manuals, CRF completion guidelines, study specific instructions, etc.
* Provides timely and accurate information to Project Management for program level tracking.
* Participates in evaluating study drug supply requirements and manages the logistical aspects of distributing supplies to the investigational sites.
* Coordinates investigator meetings and develops presentation materials.
* Routinely reviews study data and progress of EDC entry; works with data management and clinical sites to resolve data discrepancies.
* Identifies program/clinical trial risks; proactively suggests and implements mitigation strategies.
* Participates in the evaluation, selection and eventual management of vendors.
* Participates in the preparation and finalization of company SOPs.
* Performs job duties with minimal supervision and has a sound critical thinking and problem solving skills.
* Ability to travel up to 30%.
Qualifications/Experience:
* Qualifications include a BA or BS within a scientific discipline, or an equivalent combination of education and work experience.
* Minimum of five years related experience and/or training, four of which include Clinical Research Associate with lead CRA or Team Leader experience.
* A strong medical/science background with oncology experience.
* Prior global trial experience required.
* Knowledge of GCP/FDA/ICH regulations required.