Clinical Trial Assistant

Duties:

The incumbent is responsible for the day-to-day support of clinical studies. Assisting and providing support to the members of the clinical operations project team in order to facilitate the management clinical trial processes including planning, execution, and closeout of outsourced clinical trials. The incumbent will ensure that the trial is conducted in compliance with the protocol, ICH good clinical practice, applicable regulatory requirements and applicable standard operating procedure work instructions. This role may be responsible for managing specific study and operational tasks and hold vendor management responsibilities.

KEY ROLE AND RESPONSIBILITIES:

• Develop and distribute meeting agendas, minutes and monthly status reports to document key project updates and communications to relevant stakeholders, as requested. Support Clinical Trial Management in communication to CRO, Vendors and Investigator Sites.

• Support the Clinical Trial Manager with study start-up activities, to include preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, study logs and forms Site Contracts and Budgets, Vendor Contracts and Budgets, etc.).

• Support the Clinical Trial Manager in the tracking of subject recruitment at all study sites; monitoring visits and approval; infringements, breaches, and misconduct, fraud, and negative trends and protocol deviations. Notify CRO and sites of updates on global study information.

• Assist project team in the collection, review and filing of site Essential Documents, and maintenance of the TMF. Assist in the tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS.

• Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies. Support the Clinical Trial Manager in formal risk assessment activities; review and corrective action plans across study, participates in the planning of quality assurance activities, internal and external audits/inspections, and coordinates communication of audit/inspection findings.

• Participate in regular team meeting / teleconferences; CRO, Vendor and Investigator Site meetings as necessary; and Investigator Meetings, as necessary.

• Communicate any out-of-scope issues to the Clinical Trial Manager as soon as identified.

• Communication and support Clinical Trial Manager with cross-functional study team interaction.

• Other duties as assigned.

Skills:

Demonstrated experience operating effectively in a clinical environment

Experience working with clinical protocols

KNOWLEDGE, SKILLS AND ABILITIES:

Excellent verbal and written communication skills required.

Excellent organizational, multi-tasking and time management skills required.

Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines

Education:

BSC in in biomedical sciences or related scientific discipline with 2 years clinical research experience.