ICON Strategic Solutions
Study Start Up Specialist (Hybrid San Diego, CA)
ICON Strategic Solutions, San Diego, California, United States, 92189
ICON Strategic Solutions is hiring a Study Start Up Specialist to support one client in our FSP division. This is a hybrid position in San Diego, CA
Responsibilities
Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with Client’s SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
Coordination of all necessary translations required for any start-up documentation.
Attend study team meetings as required.
Responsible, as assigned, for one or more of the following tasks related to each of the key study start- up and/or maintenance activities:
Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):
Prepare, review and approve Global Master ICF templates for Sponsors.
Prepare, review and approve Country Master ICF templates inserting any required country elements. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.
Proficiently negotiate Informed Consent Forms (ICF) with Study Sites to ensure the Site Specific ICF meets local requirements and contains all required elements from Country Master ICF. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.
Proficiently review, negotiate and approve all Ethics Committee (EC), Institutional Review Board (IRB) and Competent Authority (CA) queries to Country and Site Specific ICFs.
Proficiently prepare, review and approve amended Global, Country and Site Specific amended ICFs.
Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions:
Proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
Effective interaction with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start up and maintenance as assigned).
Forecast submission/approval timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are at risk, and elevate issues as soon as identified.
Preparation, Submission, Review and Approval of Critical Document Package (CDP):
Proficient essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines.
Preparation and submission of site level critical documents which are part of the Critical Document Package (CDP) to the Central CDP Review Team (CDPRT) and Sponsor.
Review and approval of Critical Document Package (CDP).
Investigational Product (IP) release in accordance with regulatory and Sponsor requirements.
Accurately forecast CDP Approval timelines and ensure they are reflected accurately in Client’s systems, proactively follow through for achievement to plan; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are at risk, and elevate issues as soon as identified.
Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.
Qualifications
Bachelor's degree in life sciences or a related field.
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH‑GCP and local regulatory requirements.
#J-18808-Ljbffr
Responsibilities
Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with Client’s SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
Coordination of all necessary translations required for any start-up documentation.
Attend study team meetings as required.
Responsible, as assigned, for one or more of the following tasks related to each of the key study start- up and/or maintenance activities:
Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):
Prepare, review and approve Global Master ICF templates for Sponsors.
Prepare, review and approve Country Master ICF templates inserting any required country elements. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.
Proficiently negotiate Informed Consent Forms (ICF) with Study Sites to ensure the Site Specific ICF meets local requirements and contains all required elements from Country Master ICF. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.
Proficiently review, negotiate and approve all Ethics Committee (EC), Institutional Review Board (IRB) and Competent Authority (CA) queries to Country and Site Specific ICFs.
Proficiently prepare, review and approve amended Global, Country and Site Specific amended ICFs.
Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions:
Proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
Effective interaction with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start up and maintenance as assigned).
Forecast submission/approval timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are at risk, and elevate issues as soon as identified.
Preparation, Submission, Review and Approval of Critical Document Package (CDP):
Proficient essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines.
Preparation and submission of site level critical documents which are part of the Critical Document Package (CDP) to the Central CDP Review Team (CDPRT) and Sponsor.
Review and approval of Critical Document Package (CDP).
Investigational Product (IP) release in accordance with regulatory and Sponsor requirements.
Accurately forecast CDP Approval timelines and ensure they are reflected accurately in Client’s systems, proactively follow through for achievement to plan; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are at risk, and elevate issues as soon as identified.
Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.
Qualifications
Bachelor's degree in life sciences or a related field.
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH‑GCP and local regulatory requirements.
#J-18808-Ljbffr