Cedars-Sinai Clinical Research Specialist - Protocol Development (Cancer Institute) in United States
The Samuel Oschin Comprehensive Cancer Institute is looking for a Clinical Research Specialist I - Protocol Development to join their team. The Clinical Research Specialist I - Protocol Development will provide clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Department Specific Job Duties:
Work as a specialist in the SOCCI CRO Protocol Development Core for investigator initiated research
Lead major initiatives in protocol development core such as: developing and implement new processes, develop manuals and other guidance documents, standard protocol language, forms, worksheets, instructions and tools, establishing template and guidance documents. May also provide input or help develop training materials for staff and/or investigators.
Responsible for establishment and maintenance of case report forms, data dictionary, forms, templates, tools and other resources.
Provides central coordination of database development for individual studies and manages data compliance, queries and submission timelines.
Serves as a central resource to assist investigators with posting and results reporting as they relate to study outcome measures, to national registry and results databases in accordance with regulations (i..e FDAAA, NIH and ICJME) and liaisons with biostatistics.
Provides training and education on best practices
Designs forms for data collection.
Serves as central point of contact and works with cross-functional team members (i.e. biostatistics, research informatics etc) to ensure sound protocol and logistic set up
Serves as advisor or consultant to junior staff and external non-CRO groups
Work with SOCCI CRO leadership to expand protocol development core to support multi-site IITs.
Lead major projects in SOCCI CRO or enterprise wide consistent with strategic plans/direction
Tracks metrics and reports on protocol development core’s performance
May provide administrative protocol review to ensure language is consistent with regulatory obligations and helps ensure consistency throughout protocol. Responsible for protocol formatting and version control.
May assists in protocol writing for standard CRO sections of the protocol and may develop standard language as appropriate
May support investigators with FDA correspondence to ensure compliance with federal regulations for institutionally/PI held IND/IDEs
May provide regulatory support for IIT/IIS such as IRB submissions, regulatory documents, continuing reviews and ongoing binder maintenance and respond to Quality Assurance (QA) findings by providing corrective/preventative action plans, training, instituting new processes or equivalent
May provide fiscal management (i.e. budgeting, accounting, cost projections) for assigned IIT/IISs
Summary of Essential Job Duties:
Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
Coordinates research projects at an institutional or departmental level.
Communicates project status and improvement areas with leadership in a timely manner.
Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
Provides guidance regarding project planning, project logistics, and project implementation
Serves as an internal consultant for specific departmental activities
Provides research writing activities such as, developing scientific documents for abstracts, publication s,
presentations, funding applications, and study protocols.
May implement and coordinate department -wide initiatives such as research quality management or clinical trial recruitment efforts
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board
Maintains research practices using Good Clinical Practice (GCP) guidelines
Maintains strict patient confidentiality according to HIPAA regulations and applicable law Participates in required training and education programsExperience:
Five (5) years minimum experience in area of research specialty.
Strong technical skills a must. Experience with RedCAP or equivalent preferred.
ACRP/SoCRA (or equivalent) certification preferred.
Physical Demands: (e.g., lifting, standing, walking)
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.