Senior Clinical Research Associate I - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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