Clinical Trial Assistant

**For GCO**: Services/deliverables include the management of all documents and logístical and administrative tasks related to trial feasibility, start-up, execution and close out of clinical trials. Ensures trial related activities are compliant with GCO SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC) and local regulatory requirements. Further services/deliverables will include technical regulatory document review, including Informed Consent Forms. Partners with the Local Trial Manager (LTM) and Site Manager (SM) to ensure overall site management while performing trial related activities for assigned protocols.

**For CTLD**: Services/deliverables include the support of the protocol specific training process, management of forms used to track, administer and document completion of protocol specific training.

Further services/deliverables will include ensuring study related activities are compliant with Global Development SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC) and local regulatory requirements; Services also include filing and maintenance of training materials in the Clinical Trial Learning & Development Training Library and the Trial Master File System at the direction of the Therapeutic Area (TA) Lead(s).

**For PDO**:
Global Portfolio Support and administration.

**Deliverables**:

- Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
- Complies with relevant training requirements.
- Provides the following deliverables: tracks progress of the clinical trial, manages study data, budget, investigational products, mailings and correspondence and other relevant tasks in support of the LTM/TM and SM.
- Maintains trial, country and site level protocol information in trial management systems, including but not limited to relevant systems to ensure appropriate safety update distribution.
- Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site(s) within required timeframes.
- Collects and files all documents throughout the trial and post-trial (GCO) or protocol specific training related documents (CTL&D). Uses appropriate systems to ensure file completeness at designated study milestones. Coordinates archiving of paper study relevant documents/files.
- Ensures audit and inspection readiness.
- Provide process improvement suggestions if applicable.

**GCO specific**:

- Negotiates site requested changes to the confidential disclosure agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations and alerts as applicable; and other relevant tasks in support of study feasibility and site assessments.
- Collects/prepares documents required for study, such as start-up/submission to the IEC/IRB and HA, in support of the LTM/TM/SM where applicable.
- Collects and tracks financial disclosure information at appropriate timepoints in accordance with procedural documents.
- Prepares study files for investigational sites and co-ordinates the development of associated documents and review them for completeness and accuracy.
- Provides updates to study specific internal data repositories to ensure availability of trial documents to the study team.
- If requested, manage study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary.
- If requested, organizes training for SM(s) and/or SIV/small investigator meetings.
- If applicable, region-specific deliverables will be specified.

**CTLD specific**
- Enable the strategy for training material version control, consistency and accessibility by maintaining training library content, relevant workflows and permissions
- Contribute to Global Development quality goal of proper filing and maintenance of the TMF by reporting issues related to filing and functionality of site staff training related documents
- Full utilization by timely and accurate time reporting

**PDO specific**
- Supporting a dedicated Therapeutic Area lead by an OH
- Portfolio access reports and distribution
- Manage (Trial) SharePoints and (Trial) Team Sites
- Coordinate Stakeholder meetings with needed materials and follow ups in concert with OH (or delegated owner)

**ADVANCED**
- Autonomy in execution of clinical trial assistance services or CTL&D assistance services
- Depth of knowledge with clinical trial assistance services. or CTL&D assistance services
- Provide coaching/mentoring to less experienced CTAs or less experienced members of the CTL&D assistance services, if applicable.

**CTL&D specific**:

- Depth of knowledge with Janssen Site Staff Training process and support services
- Advanced skills and knowledge of the Trial Master File system with research and resolution of issues
- Process leadership

**Interfaces - Primary/Other**:

- Primary i