Sr. Clinical Trial Associate
GENERAL
Summary:
4DMT seeks a motivated and experienced Senior Clinical Trial Associate to support the Company's clinical trial activities. This position reports to the CTM/Sr. CTM, Clinical Operations and will be responsible for supporting the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close-out activities. This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines. This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.
Responsibilities:
Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management
Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing
Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking
Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
Ensure timely updates are provided to CTM for updating of 'Clinicaltrial.gov' (site updates/changes)
Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
Assist with the development of site tools and clinical trial start-up activities
Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
Assist in tracking of trial IP and development of Pharmacy Manuals
Participate in study vendor set up and specification process, as appropriate
Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities
Assist with tracking of clinical trial progress including status update reports, as requested
Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
Other duties as may be assigned
Qualifications:
BA/BS, degree required
At least 2 years of work experience supporting clinical trials
Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook
Ability to prioritize and manage competing priorities
Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
Willing to travel as business needs demand (Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
4DMT seeks a motivated and experienced Senior Clinical Trial Associate to support the Company's clinical trial activities. This position reports to the CTM/Sr. CTM, Clinical Operations and will be responsible for supporting the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close-out activities. This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines. This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.
Responsibilities:
Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management
Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing
Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking
Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
Ensure timely updates are provided to CTM for updating of 'Clinicaltrial.gov' (site updates/changes)
Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
Assist with the development of site tools and clinical trial start-up activities
Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
Assist in tracking of trial IP and development of Pharmacy Manuals
Participate in study vendor set up and specification process, as appropriate
Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities
Assist with tracking of clinical trial progress including status update reports, as requested
Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
Other duties as may be assigned
Qualifications:
BA/BS, degree required
At least 2 years of work experience supporting clinical trials
Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook
Ability to prioritize and manage competing priorities
Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
Willing to travel as business needs demand (Estimated Salary: $20 to $28 per hour based on qualifications.
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