Descripción de la oferta
Sr CRA Spain
The Senior Clinical Research Associate (Sr CRA) is a key member of the Alira Health Clinical team. The Sr CRA independently conducts site monitoring activities, oversees clinical trial execution, and ensures protocol compliance and quality throughout the study life cycle.
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 cross‑functional departments to facilitate negotiation and issue resolution for monitoring related issues.
Assists in development of study‑specific monitoring plans and training presentations.
Assists in set up/collection of site‑specific ethics documents and site contract negotiation.
Provides monthly billing information to finance team.
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.
Prepares accurate monitoring visit reports documenting site‑related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Ensures integrity of CRF data through meticulous source document review and verification.
Conducts 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 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 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.
Conducts audit preparation at study sites as needed.
Collaborates 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 the Clinical Trial Management System (CTMS).
Manages and resolves conflicting priorities to deliver on commitments.
Performs additional duties as assigned.
Qualifications and Experience
US: BS/BA from an undergraduate program (life sciences or related discipline preferred).
US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience with 1 year of management experience.
EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and ability to autonomously manage monitoring activities.
Technical Competencies & Soft Skills
Quality focused; proven ability to be careful, thorough, and detail‑oriented.
Strong organizational skills and the ability to multi‑task 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.
US: Strong command of English, both written and verbal.
EU: 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, 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.
Ability to establish and maintain positive relationships with sponsor, site, and project team members.
EU: Graduation in a scientific health field.
EU: Adequate English.
Languages
English
Education
Bachelor of Science (BS): Biology, Biotechnology, Life Sciences, or Pharmacy
Contract Type
Regular
Salary Range
€55,000 – €65,000
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