Clinical Trial Assistant

Singapore, Remote

**Job ID** R0000017969

**Category** Clinical Trials

**ABOUT THIS ROLE**:
The Clinical Trial Assistant (CTA) is responsible for driving and/or supporting key clinical trial tasks for assigned studies from study start-up to study close-out and provides administrative support to Clinical Operations (CO) team.

Support trial during study start-up
- Set-up Trial country relevant documents
- Create local signature page
- Set-up share point, 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)
- Support for site contract preparation/negotiation/execution (CTM provides template, CRA responsible for site adaptation)
- 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 (eg. Investigator Brochures, signature pages)

Other Activities:

- 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 staffs, and internal staffs (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 (eg. 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

date (eg. patient numbers/site contacts/duration of insurance coverage)
- Organize shipment of paper documents collected
- Support man