The primary role of the Cancer Clinical Trials Office Investigator-Initiated Trial Specialist is to provide support, coordination and effective management for Investigator Lead Clinical Trials. Working side by side with the PI to provide clinical research expertise by participating in the design and implementation of research projects as needed. The responsibilities include training and professional development of research staff members and physicians.
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Duties of an Investigator Initiated Trial Specialist may include the following but are not limited to:
Provides all required administrative and oversight of Investigator Initiated Trials (IIT) study progress. Including but not limited to protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committee. Working closely with PI’s they will evaluate with study protocols with appropriate staff members for suitability and feasibility.
Supports investigators with all FDA correspondence to ensure compliance with federal regulations for institutionally/PI held IND/IDEs.
Provides administrative protocol review to ensure language is consistent with regulatory obligations and helps ensure consistency throughout protocol. Responsible for protocol formatting and version control. Reviews the entire protocol document for content, consistency, clarity, formatting, and grammar to ensure a submission-ready document.
Development and entry of case report forms in a digital format.
Working with investigators and biostatisticians, ensure that data to support primary objectives and endpoints are included.
Working with Safety and Data Quality Office and Clinical Trials Office leadership, develop systematic and industry best practice approaches to case report form development to support quality control and monitoring efforts while improving efficiency of data entry.
Work with management to develop processes for investigator initiated trials including: developing process workflows, manuals, standard protocol language, forms, worksheets, instructions and tools, establishing template and guidance documents.
Coordinate responsibilities and data collection on multi-site studies when necessary.
Responsible for assisting PI in protocol registration for clinicaltrials.gov and clinical trials reporting program (CTRP) and results posting to applicable sites for IITs.
Reviews Food and Drug Administration applications made on behalf of University sponsor-investigators for accuracy and compliance to Federal Code of Regulations by identifying and reporting deficiencies to the principal investigator, study team and DSMC.
Assists in study budget building with Finance Manager.
Work with Quality Manger to creates, revises and implements company SOP’s to all applicable study staff.
May provides regulatory support for the Quality Assurance and Process Improvement Unit (QIU).
Attends and participates in Clinical Research Team meetings.
Creates monthly study status report(s) and maintains study metrics; maintains appropriate trackers, generates routine and ad-hoc reports and provides project management support to ensure timely protocol development and activation and portfolio management.
Maintains research practices using Good Clinical Practice (GCP) guidelines, strict patient confidentiality according to HIPAA regulations and applicable law and ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Bachelors or Higher in a related field.
3 years’ experience with investigator initiated studies in the clinical research environment in a health care setting.
Knowledge and experience in designing and developing clinical trials regulatory guidelines and requirements for the conduct of Clinical Trials.
Fluent in Microsoft Office applications.
Organized and detail oriented.
Master’s Degree or PhD.
Additional years of clinical research, grant submission, and medial writing experience.
ACRP/SoCRA (or equivalent) certification.
Knowledge of multi-site studies.
Working with industry partners including Phase 1 designs and IND development/communications.
Knowledge of policies and procedures that govern clinical research and research subject’s protection including US Federal Regulations, FDA; International Committee on Harmonization, Good Clinical Practices, HIPPA, NCI/CCSG requirements and NIH requirements.