At a Glance
- Tasks: Support site start-up activities and maintain relationships with study personnel.
- Company: Join Alimentiv, a leader in clinical research and project management.
- Benefits: Enjoy remote work flexibility and competitive salary plus bonuses.
- Other info: Home-based role with opportunities for growth and training.
- Why this job: Be part of impactful studies while developing valuable skills in a dynamic environment.
- Qualifications: 1-3 years of relevant experience or a degree in Health or Life Sciences required.
The predicted salary is between 27500 - 45500 £ per year.
Support Project Management, Regulatory, and Contract and Legal in all site-related start-up activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site start-up. Prepare, distribute and follow-up on start-up documents with sites. Plan and track site start up activities and data using designated systems and tools. Provide reports on intelligence and metrics related to study start-up activities.
Site Start-Up Packages- In cooperation with Project Management create study-specific start-up document package.
- Distribute and follow up with sites to obtain the required executed documents.
- Review content and correctness of returned documents from the sites, in accordance with internal standards.
- In conjunction with Regulatory Affairs, ensure that the correct and complete packages are obtained within the planned timelines.
- In co-operation with Contract and Legal, obtain feedback on suggested site and investigator contract language.
- Act as main point of contact for sites to obtain feedback on budget and contract negotiations.
- In conjunction with the Project Manager, provide sites with the suggested study budget and negotiate within pre-approved margins.
- Maintain site intelligence tracker with data related to specific requirements for study sites such as start-up timelines, budget, contract negotiation timelines and prerequisites, patient recruitment data, etc.
- Provide input for suggested site list during start-up using past experiences with potential studysites.
- Act as main contact for study sites during start-up.
- Develop and maintain relationships with study sites that will facilitate timely completion of start-up.
- In conjunction with project management and CRAs, plan start-up actions and provide expected SIV dates for individual sites based on previous start-up metrics, as well as regulatory and /RB timelines.
- Track progress of start-up activities in smart sheet and/or CTMS.
- Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentations.
- Provide support to project management with study related activities as required.
- Applicants should have a minimum of one to three years of related work experience with ongoing training, or a minimum of a one-year College Advance Diploma/Degree in a relevant field of study, preferable in Health or Life Sciences, or Clinical Research. The successful candidate must exhibit the following skills: Excellent communication skills. Knowledge of start-up requirements for clinical sites. Experience in working directly with clinical study sites through previous involvement in studies. Very high sense of urgency.
- Home-based
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*Accommodations for job applicants with disabilities are available upon request.
#J-18808-LjbffrStudy Start Up Specialist in Belfast employer: Alimentiv
At Alimentiv, we pride ourselves on being an exceptional employer that fosters a collaborative and supportive work culture. As a Study Start Up Specialist, you will benefit from flexible home-based working conditions, competitive salary packages, and opportunities for professional growth within the dynamic field of clinical research. Our commitment to employee development and well-being ensures that you can thrive while making a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Study Start Up Specialist in Belfast
✨Tip Number 1
Familiarise yourself with the specific start-up requirements for clinical sites. Understanding these nuances will help you engage more effectively with study personnel and demonstrate your expertise during any discussions.
✨Tip Number 2
Build a network within the clinical research community. Attend relevant webinars or local meet-ups to connect with professionals who can provide insights into the role and potentially refer you to opportunities at StudySmarter.
✨Tip Number 3
Stay updated on regulatory requirements and compliance standards in clinical research. This knowledge will not only boost your confidence but also show potential employers that you are proactive and well-informed.
✨Tip Number 4
Practice your communication skills, especially in negotiating and relationship-building scenarios. Being able to articulate your thoughts clearly and persuasively is crucial for the role of a Study Start Up Specialist.
We think you need these skills to ace Study Start Up Specialist in Belfast
Some tips for your application 🫡
Understand the Role:Before applying, make sure you fully understand the responsibilities of a Study Start Up Specialist. Familiarise yourself with the key tasks such as supporting project management and regulatory activities, and maintaining relationships with study sites.
Tailor Your CV:Highlight relevant experience in your CV that aligns with the job description. Emphasise any previous work with clinical study sites, project management, or regulatory affairs to showcase your suitability for the role.
Craft a Compelling Cover Letter:Write a cover letter that specifically addresses how your skills and experiences meet the requirements outlined in the job description. Mention your communication skills and any experience with contract negotiations or site start-up processes.
Proofread Your Application:Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail.
How to prepare for a job interview at Alimentiv
✨Know the Role Inside Out
Make sure you thoroughly understand the responsibilities of a Study Start Up Specialist. Familiarise yourself with site-related start-up activities, regulatory requirements, and the importance of maintaining relationships with study personnel.
✨Demonstrate Your Communication Skills
Since excellent communication is key for this role, prepare to showcase your ability to convey information clearly. Think of examples where you've successfully communicated with clinical study sites or managed negotiations.
✨Showcase Your Organisational Skills
Be ready to discuss how you plan and track activities. Highlight any experience you have with project management tools or systems, as well as your ability to maintain up-to-date knowledge of regulatory requirements.
✨Prepare Questions for the Interviewers
Have insightful questions ready about the company's approach to study start-up processes or how they measure success in this role. This shows your genuine interest and helps you assess if the company is the right fit for you.
