Clinical Research Associate - FSP

Parexel is seeking a Clinical Research Associate to support clinical trial delivery for assigned investigator sites. The role oversees site monitoring from activation through database lock, ensures regulatory and protocol compliance, manages site issues and safety reporting, and collaborates with study teams to achieve quality and timeline objectives.

Responsibilities

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

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 and recruitment 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

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

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 Mentor / Train Clinical Research Associates and Sr CRA I as assigned

May serve as an SME on related initiatives / planning

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

Preferred

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

Oncology experience

Vaccines experience

Internal Medicine experience

Infectious Diseases experience

Benefits

Remote work arrangement

Company

Global clinical research and biopharmaceutical services company

Raleigh, North Carolina, USA

http://www.parexel.com/

Founded in 1983

10001+ employees

Qualifications

Extensive knowledge of clinical trial methodologies, ICH/GCP and local country regulations

Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring

Global clinical trial experience

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

Significant travel is required

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

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

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

Required skills

Clinical Trial Methodologies, Clinical Research Site Monitoring, ICH-GCP, Clinical Trial Regulatory Compliance, Oncology, Global Clinical Trials, Clinical Research and Development Processes, Protocol Design and Feasibility Assessment, Regulatory Inspections and Sponsor Interactions, Risk Management and Mitigation, Multilingual Proficiency

Experience

3+ years