Senior Clinical Research Associate - FSP

Parexel; Augusta (ME); On-site; USD 85,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate I to oversee site management, monitoring and close-out of investigator sites across trials, ensuring patient safety and adherence to GCP and client standards.

The role requires leading site delivery from activation to database lock, active collaboration with the Site Care Partner and study team, and substantial travel (60–80%). English fluency and oncology experience are highly valued.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 3+ years of clinical research site monitoring experience ( Oncology preferred).
• Strong knowledge of ICH-GCP, FDA regulations and local country requirements.
• Fluent in English; local language skills as applicable.
• Willingness to travel 60–80% within region and some international travel.

Responsibilities

• Oversee monitoring responsibilities and study conduct to meet SMP, timelines and quality.
• Manage operational aspects from site activation to database lock.
• Serve as primary contact for investigator sites and coordinate with SCP for site delivery.
• Facilitate information flow among study team, vendors and investigator sites.
• Provide site development and training to ensure protocol compliance and patient safety.
• Attend investigator meetings and support site activation and recruitment.
• Conduct onsite and remote monitoring and manage site close-out activities.
• Monitor AEs/SAEs and assist with timely reporting and follow-up.

Skills

Clinical trial monitoring

GCP/ICH-GCP

FDA/regulatory knowledge

English fluency

Travel readiness

Stakeholder communication

Site relationship management

Oncology/Vaccines/IM/ID experience

Education

Bachelor's degree in life sciences

Job description

Job Overview:

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 escalation 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

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, 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

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.