Senior Clinical Research Associate - 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.

Parexel FSP is looking for Sr CRAs to join our team. Candidates can be based in São Paulo, Rio de Janeiro or Porto Alegre.

Job Summary
The Senior Clinical Research Associate I (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and client standards. The Sr.

CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.

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 

 Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites 

Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks 

 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

Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities 

 Support database release as needed

May undertake the responsibilities of an unblinded monitor where appropriate

Clinical/Scientific and Site Monitoring Risk
Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team

Interact with investigator site heath care professionals in a manner which enhances the client’s credibility, scientific leadership and in order to facilitate the client’s clinical development goals 

 Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators 

Drive Quality Event (QE) remediation, when applicable 

Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable

Collaboration
Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) 

Partners with SCP and Country Study Operations Manager (SOM) 

When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) 

May act as a Mentor for Clinical Research Associates

Compliance with Parexel standards
Complies with required training curriculum 

Completes timesheets accurately as required 

Submits expense reports as required 

Updates curriculum vitae (CV) as required

Maintains a working knowledge of and complies with Parexel processes, International Conference on Harmonization (ICH) - GCPs, and other applicable requirements

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 and in the native language(s) of the country they will work in

 Significant travel (60-80%) within area is required. May require some international travel and some weekend travel 

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

Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial

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

Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization 

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