Clinical Research Associate CRA

Job Description

Summary:

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.

• 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.

• Graduation in a scientific health field in the EU.
• Certified Monitor in compliance with Italian CRO decree dated 15 Nov 2011 (Italy).
• Ability to establish and maintain positive relationships with Sponsor, Site, and Project Team members.
• Ability to autonomously manage monitoring activities.

• Quality focused; proven ability to be careful, thorough, and detail‑oriented.
• Strong organizational skills and ability to multi‑task and work effectively in a fast‑paced environment.
• Ability 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).

• English Language:
  Adequate.
• Education:
  
  Bachelor of Science (BS):
  Biology;
  Bachelor of Science (BS):
  Life Sciences.