Required:
* Associates Degree
* 3 years of Clinical Research Experience
* BLS
Preferred:
* Bachelors Degree
* SoCRA or ACRP Certification
* Phlebotomy Certified
* Medical Assistant Diploma
* Experience with Oncology setting
Primary Duties and Responsibilities
* Establishes and executes logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
* Coordinates administrative functions of research studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, SAE's and source documents.
* Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
* Responsible for accurate and timely data collection, documentation, entry and reporting, including resolution of queries from sponsors or regulatory entities.
* Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions.
* Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
* Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
* Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
* Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency as needed.
* Provides technical support for the preparation of grant proposals, publications, presentations and special projects.
* Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care and provides assistance with research participant research billing and reconciliation.
* Attend meetings and conferences related to research activities, including research staff meetings.
* Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested; Participates in training and education of new research personnel.
Required + Booster - No Exemptions, Current Booster
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