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Senior Initiation Clinical Research Associate

求人ID 65108BR ロケーション アクスブリッジ, イングランド 仕事内容
Parexel strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.

We are hiring for a Senior Study Start up Specialist (Sr ICRA) for our UK Clinical Operations group. This role will be situated at our UK Head office in Uxbridge as well as having the possibility of some home-based working. You must have a strong background and previous experience of working in a study start up position within a CRO environment. Please apply below if you are interested and have the relevant SSU experience.

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)
- Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct remote Qualification Visits (QVs).
- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- 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,
- Site activation,
- Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
- Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.

Qualifications

Education:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.

Skills:
- 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 UK EC submission experience
- Advanced level knowledge and use of the IRAS System/Amendment tool.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary as well as a benefits package including 25 days holiday per year, strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading edge benefits that you would expect with a company of this type.

If you are ready to join PAREXEL’s Journey, please apply!
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