Clinical Research Feasibility Specialist
4 weeks ago
As a Clinical Research Feasibility Specialist at Pharmiweb, you will play a crucial role in the start-up phase of clinical trials. Your primary responsibility will be to coordinate and manage the feasibility assessments of potential study sites, ensuring that they meet the necessary criteria for conducting clinical trials.
Key Responsibilities:
- Feasibility Assessments: Conduct thorough assessments of potential study sites to evaluate their suitability for clinical trials. Collaborate with site investigators and study teams to gather necessary information and assess site capabilities.
- Site Selection: Identify and recommend potential study sites based on feasibility assessments and strategic alignment with study goals. Perform Investigator due diligence checks in accordance with company SOPs and Clinical Operations processes.
- Regulatory Submissions: Prepare and submit regulatory documents required for study start-up, including IRB/EC submissions and regulatory agency applications. Ensure compliance with all applicable regulations and guidelines.
- Start-Up Coordination: Coordinate site initiation visits and ensure all required documentation and contracts are in place before study start. Work closely with Clinical Operations, Regulatory Affairs, and other departments to ensure smooth study start-up processes.
- Documentation and Reporting: Maintain accurate and up-to-date records of all study start-up activities. Provide regular updates and reports to management on the status of study start-up activities.
- Compliance and Quality: Ensure adherence to company SOPs, GCP, and other regulatory requirements. Participate in audits and inspections as needed.
Requirements:
- Bachelor's Degree in Business, Life Sciences, or Paralegal
- Minimum 3 years of independent study start-up/feasibility experience in clinical research
- Strong understanding of clinical trial processes, regulations, and guidelines
- Excellent organizational and project management skills
- Ability to work independently and manage multiple projects simultaneously
- Strong communication and interpersonal skills
- Proficiency in MS Office Suite and clinical trial management systems (CTMS)
What ICON Can Offer:
At Pharmiweb, we value diversity, inclusion, and belonging. Our rich diversity makes us more innovative, helping us better serve our people, patients, customers, and communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates. Pharmiweb is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
We encourage you to apply regardless of whether you meet all of the requirements. There's every chance you're exactly what we're looking for here at Pharmiweb, whether it's for this or other roles.
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