Your role:

• Manages or support all clinical aspects of a study, including assessing operational feasibility; assist in managing Clinical study timelines and metrics; provides study-specific training and leadership to clinical team; prepares and presents project debriefings, as required; plan, execute, lead or support study-specific meetings (e.g., Study Management Meetings, investigator meetings). Responsible for ensuring that Clinical Team delivers timely and high-quality project
• Site Management: Track and manage subject recruitment at all study sites. Oversee or supports the management of study Monitoring Visits, and review and approval of Monitoring Reports. Monitor study/site performance on an ongoing basis and escalate any infringements, breaches, and misconduct, fraud and trends at sites. Ongoing protocol deviation tracking, reporting, and trending. Notify sites of updates on global study information and updates.
• Study Start-Up: Uses operational and therapeutic expertise to optimize trial execution. Determine or contribute to the list of approved sites for selection visits. Plan or assist in allocating clinical team resources. Determine, develop and implement tracking and reporting specifications. Works with the study team to design clinical protocol; provides input for the design of the ICF template, source documents worksheets, and CRFs. Prepares and/or reviews study-related documents to include, visit report templates and annotations, clinical logs, forms, manuals and guidelines.
• Document and Supplies Management: Oversee or support the collection, review and filing of site essential documents, and maintenance of the TMF. Coordination of IP and clinical study supplies and oversee or support the overall tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC, CTMS, or vendor-specific
• Compliances: Follow international GCP guidelines/regulations, SOPs, and study protocol for executing clinical studies. Participates in the planning of quality assurance activities and coordinates or support the resolution of audit findings.
• Staff Management: Support Clinical Management Team or act as functional Manager to Clinical operations staff allocated on assigned projects. Provides coaching and guidance to junior Clinical staff.
• Daily interaction with the Clinical Management Team and members of the cross-functional study team.
• Support study management team in selecting sites and countries; develops relationships with investigators and site staff.
• Support the cross-functional study team as needed; frequent cross-functional interactions with internal and external personnel (e.g., regulatory affairs, investigators, vendors, etc.).
• Lead or partake in regular team meeting / teleconferences; Participate/present at Client Presentation Meetings as necessary; Participate/present at Investigator Meetings as necessary.
• Communicate any out of scope issues to the Senior Clinical Management Team or Project Management Team as soon as identified.
• Other duties as assigned.

Your Profile:

• Bachelor’s Degree in biomedical sciences or related scientific discipline
• Fluent English (oral and written) and applicable local business language.
• Minimum 8 years of clinical research experience with a combination of clinical monitoring, study operations, and other relevant clinical research experience
• Excellent organizational, multi-tasking, and time management skills required
• Excellent verbal, written communication, and presentation skills.
• Sound knowledge of medical terminology and expert proficiency level in clinical trial monitoring and management process.
• Sound knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• Excellent skills at documenting study conduct and management.
• Effective business skills for interactive situations with peers, sites, and clients.

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being.  Our employees enjoy half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.

Your role:

• Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution
• Provide project updates to project management team.
• Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.
• Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.
• Assists with, prepare for, and attends Investigator Meetings for assigned studies.
• Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.
• Collect and review essential study documents from site for filing in eTMF.
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
• Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, performing review and oversight of site visit reports.
• May review protocols, eCRFs, study manuals and other study related documents, as requested by the Clinical Trial Manager.
• May conduct on-site evaluation visits and on-site training of CRAs
• Lead and partake in regular team meeting / teleconferences.
• Assist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.
• May serve as mentor to associates on the subject of job performance, trainings and professional growth.
• Other duties as assigned. 

Your Profile:

• Bachelor’s Degree in biomedical sciences or related scientific discipline
• Fluent English (oral and written) and applicable local business language.
• Minimum three years of monitoring experience, more experience preferred, with a combination of clinical research coordinator and or other relevant clinical research experience.
• Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process.
• Ability to travel up to 70%, depending on project requirements.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• Good leadership, planning, project management skills, verbal communication skills, and written communication skills.
• Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint and Excel).

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.

Your role:

• Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution
• Provide project updates to project management team.
• Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.
• Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.
• Assists with, prepare for, and attends Investigator Meetings for assigned studies.
• Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.
• Collect and review essential study documents from site for filing in eTMF.
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
• Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, performing review and oversight of site visit reports.
• May review protocols, eCRFs, study manuals and other study related documents, as requested by the Clinical Trial Manager.
• May conduct on-site evaluation visits and on-site training of CRAs
• Lead and partake in regular team meeting / teleconferences.
• Assist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.
• May serve as mentor to associates on the subject of job performance, trainings and professional growth.
• Other duties as assigned. 

Your Profile:

• Bachelor’s Degree in biomedical sciences or related scientific discipline
• Fluent English (oral and written) and applicable local business language.
• Minimum three years of monitoring experience
• Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process.
• Ability to travel up to 70%, depending on project requirements.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• Good leadership, planning, project management skills, verbal communication skills, and written communication skills
• Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint and Excel).

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.

Your role:

• Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution
• Provide project updates to project management team.
• Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.
• Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.
• Assists with, prepare for, and attends Investigator Meetings for assigned studies.
• Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.
• Collect and review essential study documents from site for filing in eTMF.
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
• Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, performing review and oversight of site visit reports.
• May review protocols, eCRFs, study manuals and other study related documents, as requested by the Clinical Trial Manager.
• May conduct on-site evaluation visits and on-site training of CRAs
• Lead and partake in regular team meeting / teleconferences.
• Assist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.
• May serve as mentor to associates on the subject of job performance, trainings and professional growth.
• Other duties as assigned. 

Your Profile:

• Bachelor’s Degree in biomedical sciences or related scientific discipline
• Fluent English (oral and written) and applicable local business language.
• Minimum three years of monitoring experience, more experience preferred, with a combination of clinical research coordinator and or other relevant clinical research experience.
• Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process.
• Ability to travel up to 70%, depending on project requirements.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• Good leadership, planning, project management skills, verbal communication skills, and written communication skills.
• Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint and Excel).

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.

Your role:

• Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution
• Provide project updates to project management team.
• Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.
• Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.
• Assists with, prepare for, and attends Investigator Meetings for assigned studies.
• Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.
• Collect and review essential study documents from site for filing in eTMF.
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
• Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, performing review and oversight of site visit reports.
• May review protocols, eCRFs, study manuals and other study related documents, as requested by the Clinical Trial Manager.
• May conduct on-site evaluation visits and on-site training of CRAs
• Lead and partake in regular team meeting / teleconferences.
• Assist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.
• May serve as mentor to associates on the subject of job performance, trainings and professional growth.
• Other duties as assigned. 

Your Profile:

• Bachelor’s Degree in biomedical sciences or related scientific discipline
• Fluent English (oral and written) and applicable local business language.
• Minimum three years of monitoring experience, more experience preferred, with a combination of clinical research coordinator and or other relevant clinical research experience.
• Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process.
• Ability to travel up to 70%, depending on project requirements.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• Good leadership, planning, project management skills, verbal communication skills, and written communication skills.
• Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint and Excel).

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.