Senior Clinical Research Associate - FSP

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

Key Accountabilities:  

Oversight of Monitoring Responsibilities and Study Conduct  

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality  

Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met  

During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery  

 Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation andrecruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level 

Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies  

Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution  

Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics  

Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues  

Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines 

  Skills :  

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations  

Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)  

Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases  

Global clinical trial experience  

Must be fluent in English

Significant travel across whole Turkey

Valid driver’s license and passport required 

Knowledge and Experience:    

Demonstrated knowledge of clinical research and development processes and ability to gain command of process details  

 Demonstrated knowledge of global and local regulatory requirements  

Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)  

Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) 

Demonstrated ability to support sponsor regulatory interactions/inspections  

Demonstrated knowledge of the processes around protocol design and feasibility assessment 

Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery 

Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation  

Education :  

Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

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