Job Description
Clinical Research Associate; Oncology Monitoring Experience Required
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Overview
The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
Key Responsibilities
- Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
- Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.
- Ensures appropriate and timely investigator site visits.
- Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
- Assists in development of study-specific Monitoring Plans and training presentations as required.
- Assists in set up/collection of site specific ethics documents and site contract negotiation as required.
- Provides monthly billing information to finance team as required.
- For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.
- Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.
- Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
- Ensures integrity of CRF data through meticulous and thorough source document review and verification.
- Performs quality control and verification of documents collected at sites for eTMF/TMF.
- Conducts investigational product accountability.
- Reviews site regulatory binder for required documents.
- Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
- Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
- Participates in internal, client/sponsor, scientific, and other meetings as required.
- Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
- Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
- Proactively identifies site issues and develops problem-solving strategies for sites.
- Conducts audit preparation at study sites as needed.
- Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
- Assists in CRA new hire training and onboarding.
- Performs CRA mentoring.
- Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
- Manages and resolves conflicting priorities to deliver on commitments.
- Performs additional duties as assigned.
Qualifications & Experience
- 2+ years oncology monitoring is a requirement for this position.
- EU: Graduation in a scientific health field
- EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
- Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
- Ability to autonomously manage monitoring activities
Technical Competences & Soft Skills
- Quality focused; careful, thorough, and detail-oriented
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
- Able to manage priorities, organize time and solve problems
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Ability to travel
- Ability to manage stress
- Professional, trustworthy and disciplined
- Ability to problem-solve unstructured or ambiguous challenges
- Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
- Excellent communication and interpersonal skills with customer service orientation
- Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
- Self-starter who thrives in a collaborative, yet less structured team environment
- Knowledge of clinical research, ICH GCP and local regulations
- Knowledge of Regulatory and Ethical requirements
- EU: Adequate English
Languages
English
Education
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences
Contract Type
Regular
Seniority level
Employment type
Job function
- Research, Analyst, and Information Technology
- Industries
- Pharmaceutical Manufacturing
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Job Tags
Full time, Contract work, Interim role, Local area, Remote work,