Clinical Trial Assistant

**1. Support start up activities**:

- Trial country relevant documents set-up (e.g. local CTPs) including BIRDS set-up, formatting check, initiating workflows etc.
- Create local signature page
- Set up of share point, public drives, Microsoft teams, etc.

**Start-up communication (sites)**
- Enter feasibility tracking information to BI CTMS (as Site Selection Manager)
- Site qualification follow up letter submission for filing in TMF staging area

Ethics Interactions- Support to CTM to inform TDS about trial events to trigger document collections from sites

**Other activities**:

- Investigational supplies support - communication and scheduling, obtain Import Licenses as applicable at OPU level (CTM to release green light, CRO supposed to support all other administrative but if not covered by CRO, to be supported by CTA)- Investigational non-drug supply coordination with 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

**2. Support trial during 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 COPI reports (BICTMS, Clinergize), monthly QC document findings
- Responsible for site address /personnel change, notifications and updates to related forms, supplies, BICTMS updates, and vendor’s spreadsheets etc.
- Ordering trial supplies and sending to sites (if CRO cannot support)
- Maintain Paper Trial Master File if applicable

**3. Support trial during closeout**

**Communication with sites**
- CTR synopsis submission and tracking to from/sites, Ethics Committees and or Health Authorities, as applicable (whether CRO can take it, considering KR CTR timelines that could take long)
- Support off-site archiving of Site ISFs and Pharmacy files

Archiving- 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 BICTMS

**4. Other activities as required throughout trial**
- Audits and inspection support
- Assisting trial teams in audits/inspections/CAPAs

**Training**
- Support to verify training records of site staff, and OPU BI Staff (including CRA) for amendments and updated documents (eg. TLMM)

**Meetings**
- Book clinical team meetings
- 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
- Investigator meeting and administration (flights, meeting confirmation etc., expenses reimbursement, sunshine act spreadsheet)
- Follow-up on the action items after meetings

Vendor management tracking- Access and training for all systems for vendors at site level (eg. IRT, ERT, etc. tracking/submission/maintenance of vendor spreadsheets) (In SEASK, site level covered by CRA, but to deliver information to vendors, CTA to support)
- IRT access code envelopes - distribution to CRAs
- BICTMS- BICTMS review and oversight, enter event dates, approval dates, ICFs
- Completing IDM BICTMS information request forms
- Review of site-start up form with IDMs
- Enter relevant study/site staff responsibilities, start/end dates
- Run reports from BICTMS
- Validate/cross-check TMF, TSL, BICTMS information for consistency/completeness

Investigational Study File binders- Localize and co-ordinate translation of trial templates
- 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
- Organize shipment of paper documents collected
- Management of calibration validity of sponsor loaned equipment (in case not supported by CRO)
- To 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 BI requirements
- 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 BI CTMS

**5. No study specific activities **(per assi