Job Purpose:

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 sponsor 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 sponsor standards to achieve project goals, timelines and qualityManage 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 metDuring 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 deliveryInterface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sitesPartner 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 risksAttend 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 levelConduct 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 technologiesMonitor 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 resolutionSubmit 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 metricsIdentify 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 issuesResolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelinesEnsures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activitiesSupport database release as neededMay 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 teamInteract with investigator site heath care professionals in a manner which enhances sponsor’s credibility, scientific leadership and in order to facilitate sponsor’s clinical development goalsSupport the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigatorsDrive Quality Event (QE) remediation, when applicableServe 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

Skills:

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulationsMonitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organizationPreferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious DiseasesGlobal clinical trial experienceMust be fluent in English and in the native language(s) of the country they will work inTravel (60-80%) within area is requiredValid driver’s license and passport required

Knowledge and Experience:

Demonstrated knowledge of clinical research and development processes and ability to gain command of process detailsDemonstrated knowledge of global and local regulatory requirementsDemonstrated 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/inspectionsDemonstrated knowledge of the processes around protocol design and feasibility assessmentDemonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial deliveryProven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trialAbility to evaluate, interpret and present complex issues and data to support risk management and mitigationEffective 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 is required

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