Site Ambassador

Act as Sponsor Ambassador for local Chinese sites - represents Sponsor and ensures direct line of communication from site to Sponsor is open throughout start-up, conduct and close out of clinical trials.

Visit local sites regularly (up to 50% time will be traveling and on-site)

Communicate and meet directly with Investigators and other site staff to assist with site strategy in supporting the study, i.e., Study Start Up, Enrollment, Data Entry, Patient Compliance, Regulatory etc.

Train site staff

Assist locally assigned CRA with monitoring if needed, query resolution and other study concerns to ensure prompt resolution

May Conduct or assist to conduct protocol and site feasibility assessments to ensure optimal site selection

Track Site Level activity

Help support CRSL and Global Project team located in Shanghai with any and all Study Management activities such as

• Supply and Biosample Management, Vendor management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current standard operating procedures (SOP’s) and ICH Good Clinical Practice (GCP)
• Document preparation and review as required i.e. for submissions to local committees, study conduct, etc.
• budget preparation and management including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking
• Member of the cross-functional Study Management Team (SMT). Support the CRSL in the planning, coordination, communication and documentation of the SMT
• Tracking key milestones and critical study/site activities. Provide regular updates as appropriate, to key stakeholders

Qualifications (Mininum):

• Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline
• At least 5 years monitoring experience (experienced Monitor)

• 1 to 2 years Study management experience in clinical or pharmaceutical development
• Infectious disease experience required

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