Parexel

Senior Initiation Clinical Research Associate / Study Start-Up

Company
Parexel
Location
Milan, Italy
Salary
Competitive
Posted
11 May 2021
Closes
06 Jun 2021
Ref
69724BR
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Job Description

As a Senior initiation Clinical Research Associate would will act as Parexel's direct point of contact with assigned sites and take accountable for quality and delivery during the start-up phase.
You will furthermore build relationships with investigators and site staff and conduct, drive and manage country specific feasibility and/or site prequalification 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.
  • o IRB/IEC and MoH / RA submission/approval
    o Site activation
    o 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:
  • o potential issues or risks with site activation timelines, issues with patient recruitment strategy
    o deficiencies in training, data quality or integrity
    o 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
  • Work in a self-driven capacity, with limited need for oversight.
  • Proactively keep manager informed about work progress and any issues.
  • Build relationships with investigators and site staff.
  • Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
  • Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
  • Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
  • Address/evaluate/resolve issues pending from the previous visit, if any.
  • Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
  • Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
  • Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
  • Conduct remote visits/contacts as requested/needed.
  • Generate visit/contact report.
  • Review & follow-up site payment status.
  • Follow-up on CRF data entry, query status, and SAEs.
  • Develop expertise to become a subject matter expert.
  • Work in a self-driven capacity, with limited need for oversight.
  • Qualifications

    Professional experience:
  • At least 5 years of experience in similar position
  • Work in a self-driven capacity, with limited need for oversight.

  • Skills:
  • Able to take initiative and work independently, and to proactively seek guidance when necessary.
  • 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.
  • 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.
  • Effective time management in order to meet study needs, team objectives, and department goals.
  • Developing ability to work across cultures.
  • Ability to successfully work in a ('virtual') team environment.
  • Education:
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
  • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

    Similar jobs

    Similar jobs