Site Start Up Specialist I
Parexel International Corporation
China - Shanghai - Home Based
The Senior Initiation Clinical Research Associate specialises in Pre Site Initiation Visit activities will be assigned and accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. You will also support protocol amendments if applicable.
Your Key Accountabilities:
Start-Up (from site identification through pre-initiation)
Maintenance (from initiation through close out)
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:
- IRB/IEC and MoH / RA submission/approval,
- Update and maintain appropriate Clinical Trial Management systems in a timely manner.
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.QualificationsSkills:
- Strong problem solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Excellent presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
- Strong ability to make appropriate decisions in ambiguous situations.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Excellent interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Excellent time management in order to meet study needs, team objectives, and department goals.
- Proven ability to work across cultures.
- Shows commitment to and performs consistently high quality work.
- Ability to successfully work in a (‘virtual’) team environment.
- Consulting Skills.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Act as a mentor and role model for other team members.
- Effectively enlist the support of team members in meeting goals.
- Attention to detail.
Knowledge and Experience:
- Advanced study set up, site initiation, study start up experience or equivalent clinical operations experience working in a CRO with a good understanding of both clinical trials methodology and terminology is essential
- Must have strong and in-depth China EC submission experience