At Parexel FSP people make the difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.

Our employees have the opportunity to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential.

Parexel FSP is recruiting for a Clinical Trial Specialist (Associate COL) based in Poland or Spain. Home based role. Dedicated to a single sponsor.

You will supports the Clinical Trial Manager by managing moderately complex study activities, ensuring GCP and relevant SOP compliance, assisting with vendor oversight and management, and participating in monitoring tasks as needed. They work closely with the clinical trial team to maintain study integrity and efficiency and will identify issues in a timely manner and escalate to management as appropriate.

We will offer you exceptional financial rewards, training, and development.

Expect exciting career challenges, but with a healthy work-life balance. We value your well-being as much as that of our patients.

Tasks on the role

• Support Phase 1, 2, 3 and 4 clinical studies with guidance.
• Support activities related to study/site feasibility, start-up, maintenance, and close-out.
• Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out.
• With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable (including but not limited Informed Consent Forms, study manuals, site materials, training materials, pharmacy, and laboratory related manuals, etc.)
• Study Trial Master File (TMF) oversight.
• Ensure required study documents received, reviewed, and filed in the TMF in accordance with SOPs, GCP and applicable regulations.
• Organize study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs.
• May lead and present at study related meetings.
• May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits).
• Provides rapid action to address both internal and site QA findings from audits.
• May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation.
• General study tracking and maintenance, includes but not limited to study status, enrolment, sites queries, deviations, study levels documents and plans, etc.
• Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.).  
• Study site oversight including but not limited to site performance, metrics, monitoring report review, etc.
• Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
• Work cross-functionally and provide oversite of CRO and vendor activities, including vendor management as assigned.
• Review and verification of contracted vendor activities including vendor invoice review.
• Support study reporting and tracking with applicable systems and technology.
• Support study leads in cross-functional alignment of study timelines.

Requirements:

Knowledge and Experience:

• Strong experience as CRA (at least 5 years in onsite monitoring).
• Site management experience.
• Strong vendor management experience.
• Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.
• Understanding of study phases and general knowledge of how they apply to clinical development.
• Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).
• Knowledge of the principles and practices of computer applications in database management.
• 10% - 20% travel may be required.

Skills:

• Strong verbal and written communication skills required
• Demonstrated ability to work independently and in a team environment.
• Advanced knowledge of Word, Excel, and PowerPoint.
• Ability to prioritize and manage multiple tasks simultaneously.

Education:

• BA/BS, nursing degree or equivalent required, science major preferred.
• Relevant clinical trials experience is preferred.
  

For more details contact marta.kuniewicz@parexel.com