Clinical Monitoring and Legal Representation

• Country: Chile
• Summary: Clinical Monitoring and Legal Representation
• CLT Ref No: 78567133
• Deadline: 17 Feb 2023
• Financier: Other Funding Agencies
• Purchaser Ownership: Government
• Tender Value: Refer Document
• Notice Type: Tender
• Document Ref. No.: FY23-1706176-002_RFP_03
• Purchaser's Detail:
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• Description:
• Request for proposals are invited for Clinical Monitoring and Legal Representation in Chile Date of Issue of RFP: Wednesday, February 8, 2023 Date Questions from Supplier Due: Monday, February 13, 2023, by 3pm EST Date Answers due from FHI 360: Wednesday, February 15, 2023 Date Proposal Due: Friday, February 17, 2023, by 3pm EST 1. Clinical Monitoring: • Complete all study-specific, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and research ethics training required by FHI 360 • Travel to clinical site to conduct 4-day interim site monitoring visits approximately every 4 months as described in the clinical monitoring plan and following FHI 360 SOPs • Complete visit reports using FHI 360 template and submit within 10 days of the visit as described in the clinical monitoring plan • Assist as requested with on-site training of clinical site staff for the duration of the clinical trial as directed by FHI 360 • Maintain contact with clinical research site as needed between visits and follow up with the Principal Investigator and staff on open action items and issues • Conduct the site close out visit (COV) as described in the clinical monitoring plan and following FHI 360 SOPs • Communicate with FHI 360 via email or teleconferences to provide regular updates and notify of any issues 2. Act as legal and regulatory representative on behalf of FHI 360 in Chile • Perform ISP sponsor legal representation on behalf of FHI 360 • Perform ISP submission with access to GICONA online ISP Processing system • Submit safety reports, protocol amendments and other routine reports to ISP via the GICONA system • Obtain investigational product import license and annual renewals as needed • Coordinate ancillary clinical supplies importation and customs clearance • Manage receipt, storage and transfer of investigational product using ISP approved depot Location of Work: Santiago, Chile and/or Santo Domingo, Dominican Republic Travel: Include travel cost estimates to the locations above and location where the applicant would be traveling from. Timetable and Address for Submission: Proposals are due no later than 3:00 PM EST on February 17, 2023. Required documentation listed below must be emailed to scordes@fhi360.org Qualifications: Clinical monitors must have at minimum 2 years of clinical monitoring experience. Applicants who apply to monitor in Chile must possess appropriate qualifications/registration to comply with monitoring requirements in Chile and must have experience monitoring prior clinical studies in Chile within the last 3 years. Applicants responding to legal representation activity must have legal presence in Chile.
• Documents:

 Tender Notice