OpenSpecimen (Krishagni)
Clinical Research Coordinator IU Simon Comprehensive Cancer Center
OpenSpecimen (Krishagni), Indianapolis, Indiana, us, 46262
Job Summary
Department-Specific Responsibilities Assists with development of study recruitment materials for participant contact and/or re-contact, including preparation of regulatory applications. Partners with advocates and those with expertise in community outreach and engagement to identify best practices for participant recruitment. Communicates with pathology labs and biobanks to identify appropriate biospecimens. Coordinates with current research staff to manage new data and biospecimens. Participates in the development of abstracts, manuscripts and grant proposals. General Responsibilities Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies. Participates in study budget negotiations and reconciles study budget accounts. Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed. Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor. Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and
conducting interviews; performs subject interviews and assessments for data required by protocol(s). Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.). Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events. Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply). Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators. Stays up to date with knowledge of regulatory affairs and/or issues.
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Department-Specific Responsibilities Assists with development of study recruitment materials for participant contact and/or re-contact, including preparation of regulatory applications. Partners with advocates and those with expertise in community outreach and engagement to identify best practices for participant recruitment. Communicates with pathology labs and biobanks to identify appropriate biospecimens. Coordinates with current research staff to manage new data and biospecimens. Participates in the development of abstracts, manuscripts and grant proposals. General Responsibilities Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies. Participates in study budget negotiations and reconciles study budget accounts. Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed. Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor. Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and
conducting interviews; performs subject interviews and assessments for data required by protocol(s). Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.). Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events. Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply). Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators. Stays up to date with knowledge of regulatory affairs and/or issues.
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