Clinical Trial Assistant

Support trial during study start-up

• Set-up Trial country relevant documents

• Create local signature page
• Set-up SharePoint, public drives, Microsoft Teams, etc.
• Enter feasibility tracking information to Client Clinical Trial Management System (CTMS)
• File Site qualification follow-up letter submission in Trial Master File (TMF) staging area
• Support to Clinical Trial Manager (CTM) to inform Trial Documentation Service (TDS) about trial events to trigger document collections from sites
• Support CTM with administrative aspects in managing the importation and release of Investigational supplies (communication and scheduling, obtain Import Licenses) (CTM to release green light, Clinical Research Organization (CRO) supposed to support all other administrative but if not covered by CRO, to be supported by CTA)
• Support the coordination of Investigational non-drug supply with the Clinical Supplies (if not possible by CRO)
• Co-ordinate translations of documents after review/translation (approvals, applications, advertising, patient materials, Informed Consent Forms (ICFs), etc.) and submit for TMF filing
• Support for site contract preparation/negotiation/execution (CTM provides template, CRA responsible for site adaptation)
• Update Client CTMS: add sites; site staff; event dates; ICF versions; applications; initiation checklists; update trial team members
• Set up Paper Trial Master File if applicable
  Support trial during study conduct

Site communications:

• Maintain site contact and relevant vendor and regulatory document tracker (tracking of medical licenses and follow-up/annual collection reminders)
• Printing/mailing documents and equipment to sites (if CRA is not responsible for it)

Vendor communication:

• Support CTM to inform TDS about trial events to trigger document collections for critical documents (e.g., Investigator Brochures, signature pages)
Other Activities:

• Co-ordinating translations of documents after review/translation (approvals, applications, advertising, patient materials, ICFs, etc.) and submit for TMF filing
• Support CTM to inform TDS about trial events to trigger document collection
• Support production and create local signature pages for local/global amendments
• Resolving Clinical Operations Process & Information (COPI) reports and monthly QC document findings
• Responsible for site address/personnel change, notifications and updates to related forms, supplies, Client CTMS updates, and vendor's spreadsheets, etc.
• Ordering trial supplies and sending to sites (if CRO cannot support)
• Maintain Paper Trial Master File if applicable
  Support trial during study closeout

Communication with sites:

• Support Clinical Trial Report (CTR) synopsis submission and tracking to/from sites, Ethics Committees and/or Health Authorities, as applicable
• Support off-site archiving of Site Investigator Site Files (ISFs) and Pharmacy files

Archiving:

• Support Common drive/Shareroom clean-up
• Support Paper Trial Master File archiving if applicable

Other activities:

• Coordinate the collection of equipment from sites (via CRA)
• Update Client CTMS

Support other activities as required throughout trial
Audits and inspection:

• Assisting trial teams in audits/inspections/Corrective and Preventive Actions (CAPAs)
Training:

• Support to verify training records of site staff and internal staff (including CRA) for amendments and updated documents
Meetings:

• Book clinical team meetings
• Take meeting minutes for clinical team meetings and subsequent distribution to relevant stakeholders (and sending for filing in TMF)
• Support together with CTM/meeting planners, investigator meetings
• Support Investigator meeting and administration (flights, meeting confirmation, etc., expenses reimbursement, sunshine act spreadsheet)
• Follow-up on the action items after meetings

Vendor management tracking:

• Support in requesting access and training for all systems for vendors at site level (e.g., Interactive Response Technology (IRT), eResearch Technology (ERT), etc. tracking/submission/maintenance of vendor spreadsheets), (Site level covered by CRA, but to deliver information to vendors, CTA to support)
• Support in requesting IRT access code envelopes and distribution to CRAs

Client CTMS:

• Support CTMS review and oversight, enter event dates, approval dates, ICFs
• Completing Independent Data Manager (IDM) CTMS information request forms
• Review of site-start up form with IDMs
• Enter relevant study/site staff responsibilities, start/end dates
• Run reports from CTMS
• Validate/cross-check TMF, CTMS information for consistency/completeness

Investigational Study File binders:

• Localize and co-ordinate translation of trial templates
• Support the Maintenance of trial/trial country specific trackers if applicable (if not supported by CRO)

Other:

• Document the feasibility tasks in Progress (Initial Interest, Confidentiality Agreement, Feasibility Forms)
• Submit TMF documents owned by CTM to TDS
• Apply Insurance Certificate on behalf of CTM and make sure that it is up to date (e.g., patient numbers/site contacts/duration of insurance coverage)
• Organize shipment of paper documents collected
• Support management of calibration validity of sponsor loaned equipment (in case not supported by CRO)
• Support CTM to Inform TDS about trial events to trigger document collections
• Support resolution of workflow/filing issues (appropriate issue escalation in relation to documents and vendors)
• Upload legal and other functional area documents to staging area for TMF filing according to client requirements
• Support manual processing of patient expenses and other trial-related expenses (e.g., reimbursement of site staff expenses after an IM)
• Act as Payment Manager in client CTMS
• Act as IDM of assigned trial
  Support other non-trial related activities
• Support Clinical Operations (CO) department meeting/gathering/workshop organization and arrangement including gathering of presentation materials in central e-folder
• Support CO organization chart/handover checklist maintenance
• Support Onboarding and off-boarding of CO staff
• Coordinate orientation program for new CO staff
• Support Clinical Trial (CT) insurance handling including application, payment, filing of original certificates...
• Support management of CO paper mail.
• Support PV query mailbox management
• Support Operational Unit (OPU) specific trial status report maintenance and sharing
• Support gathering of CTM Monthly Report to Line Manager
• Support signatory process coordination including DocuSign
• Act as Contract Manager/Assistant including filing of confidentiality agreement, CTA, vendor agreements in Cora and central paper file
• Act as Contact point for the archiving and archiving vendor
• Support maintenance of Office Archiving Room including management of master key log
• Support Sharedrive/SharePoint/Idea for Gen maintenance
• Liaise with office administrator for office and administrative matters including ordering of office supplies
• Liaise with Global Business Services (GBS), Finance, Purchasing for related queries
• Support consultancy case handling for payment
• Support general vendor management and payment including but not limited to couriers, travel agencies,
• Support management of POs (includes site payments or other related CO payments)
• Support CO client webpage
• Support client MyShop request for onboarding/termination of CRO staff across South East Asia and South Korea (SEASK), and maintenance and update of CRO staff list
  Skills:
• Ability to collaborate with internal team members/functional lines, CROs, vendors, and sites
• Good oral/written communication, organizational, interpersonal, and sound problem-solving skills
• Advanced presentation skills
• Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and consistently performs high quality work
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS)
• Able to multi-task under very limited direction, work independently and seek/receive guidance when necessary
• Effective time management skills in order to meet study needs, team objectives, and department goals
• Proven ability to work across cultures
• Ability to successfully work in a "virtual" team environment which may be matrixed organization
• Proficient in written and spoken English language
• Proficient in local language, as required
  Knowledge and Experience:
• Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, electronic data capture, and eTMF)

Education:

• Educated to degree level (biological science, pharmacy, or other related discipline preferred) or equivalent nursing qualification or other equivalent experience
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