Study Start Up Specialist (FSP)

Parexel are currently recruiting for an experienced Study Start Up Specialist

In this position you will be an invaluable resource responsible for supporting site start-up activities, including collection and review of essential documents, and reviewing and approving Informed Consent Forms (ICFs) for ethics committee submissions for assigned clinical sites.

Some specifics about this advertised role

• Accountable for site start-up for assigned clinical sites.
• Serves as site’s primary point of contact for start-up, resolving site queries and assisting sites with ethics committee submissions.
• Sends start-up packets.
• Reviews and approves ICFs pre- and post-ethics committee submission.
• Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with Sponsor processes and timelines.
• Assists in resolution of site queries for assigned clinical sites.
• Provides regular updates and escalates site issues to Manager, SSU.
• May attend weekly start-up meetings with Manager, SSU, Protocol Lead (PL), Clinical Contracts Manager, Legal, and other key stakeholders as necessary.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in the this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Minimum of 3 years of relevant clinical trial experience.
• Minimum of 3-5 years of pharmaceutical or biotechnology industry, preferred.
• Thorough knowledge of clinical start-up process and requirements required.
• Knowledge of CFR and ICH/GCP requirements is required.
• Requires effective organizational and time management skills.
• Able to multi-task under limited direction and on own initiative.
• Strong communication and inter-personal skills.
• Highly responsive and proactive, a team player.
• Previous start-up unit experience, preferred.
• Oncology clinical research experience, preferred

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