Website Talent Software Services, Inc.
Talent Software Services, Inc.
Company : Talent Software Services, Inc.
Primary Duties and Responsibilities
Establish and execute 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.
Coordinate 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.
Screen and recruit potential patients for protocol eligibility, present non-medical trial concepts and details to the patients, and support the informed consent process.
Ensure accurate and timely data collection, documentation, entry, and reporting, including resolution of queries from sponsors or regulatory entities.
Coordinate institutional, pharmaceutical, and internal audits, including facilitating third-party study monitoring and designing and implementing needed corrective actions.
Compile and report on each study, including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Submit adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
Identify quality and performance improvement opportunities and collaborate with staff in developing action plans to improve quality.
Plan and coordinate strategies for increasing research participant enrollment and/or improving clinical research efficiency as needed.
Provide technical support for the preparation of grant proposals, publications, presentations, and special projects.
Assist with research project budget development, including identifying and classifying routine care vs. research-related care and provide assistance with research participant billing and reconciliation.
Attend meetings and conferences related to research activities, including research staff meetings.
Participate in planning, workshops, evaluation meetings, seminars, educational or administrative meetings as necessary or requested; participate in training and education of new research personnel.
Required:
Associates Degree
3 years of Clinical Research Experience
Basic Life Support (BLS) Certification
Preferred:
Bachelors Degree
SoCRA or ACRP Certification
Phlebotomy Certification
Medical Assistant Diploma
Experience in an Oncology setting