CRA II/Senior Initiation Clinical Research Associate (Study Start-Up)
Parexel International Corporation
Milan, Lombardy, Italy
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
We are currently looking for an Initiation Clinical Research Associate II or Senior to be based in our office in Milan, Italy.In this role you will act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase specifically.
Role Responsibilities Build relationships with investigators and site staff. 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. 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. 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 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. Assess & manage test article/study supply including supply, accountability and destruction/return status. QualificationsRelevant experience in a similar role Science degree required. Medical or Pharmacy preferred. 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. Sound problem solving skills. Able to take initiative and work independently, and to proactively seek guidance when necessary. Advance 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. Willingness to work in a matrix environment and to value the importance of teamwork. Strong interpersonal, verbal, and written communication skills. Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables. Effective time management in order to meet study needs, team objectives, and department goals. Developing 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. Attention to detail. Holds a driver’s license where required