Sr Clinical Research Associate (Portugal)

Independently performs, coordinates and oversees all aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per Alimentiv’s and sponsor’s standard processes, ICH/GCP guidelines and local regulation. Serves as the primary liaison between the sponsor/Alimentiv and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II, collaborating effectively with cross-functional stakeholders in a dynamic, results-driven and high-accountability environment. Perform CRA Assessment Visits and participate in audits/inspections, when required.
Site Monitoring activities (55-60%)
Independently conduct and document onsite and remote activities, including site monitoring and close-out visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance
Collaborate with site staff to review and ensure that the data reported in the applicable study system(s) is consistent with the source documents and compliant with study requirements
Monitor, resolve and/or facilitate resolution of data queries and escalate issues as appropriate
Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents
Ensures site staff is trained in all aspects of the study including but not limited to the protocol, study plans, systems and ICH-GCP
Participate in routine study progress meetings, teleconferences, and Investigator’s meetings
Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required
Monitoring visits in Portugal and Spain
Site Management activities (15-20%)
Act as a primary contact for any questions or issues that arise from investigational sites
Oversee overall integrity of the study and promote positive working relationships with the site staff and study team members
Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements
Ensure all site related issues are followed until resolution, including action items and protocol deviations
Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle
Regularly review the study related systems remotely to ensure compliance, accuracy and completeness
Translate site documents for TMF filing when applicable
Routinely review the TMF for accuracy, timeliness, and completeness. Request documents from the site, as required
Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents
Participate in audits/inspections and follow-up on issues and implement actions, when required
Participate in routine study progress meetings and teleconferences
Site Recruitment and Setup (15-20%)
Identify and advise on site investigators selection, independently conduct and document onsite and remote activities, including site qualification and initiation visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance
Coordinate the shipment and delivery of clinical supplies, including but not limited to laboratory supplies, study documents and investigational product
Responsible for all site management activities related to site activation and work with the sites to meet clinical project timelines and milestones
Support the study Start-up team by following up on pending documents, as needed
Support the Regulatory team by reviewing, localizing and translating site documents, as required
Optimize patient recruitment providing guidance and support to site teams to meet the site recruitment milestones
Participate in Investigator’s meetings
Mentoring and Internal Initiatives (5-10%)
Mentor and support CRA I and II
Perform CRA Assessment Visits, co-monitoring visits or visit sign-off process, providing feedback
Assist the MSM hiring Manager by participating in interviews with candidates for the CRA position, as requested.
Participate in process improvement initiatives and contribute to the development of best practices
Qualifications
MINIMUM EXPERIENCE REQUIREMENTS
4 - 6 years of related experience
MINIMUM EDUCATION REQUIREMENTS
(Honors) Bachelor’s degree
PREFERRED EDUCATION REQUIREMENTS
Master’s degree
LANGUAGE REQUIREMENTS
Fluent in written and verbal English and Spanish
Or an equivalent combination of education and experience may be considered.
ADDITIONAL KNOWLEDGE / SKILLS
• Health Sciences, Life Sciences, Pharmacy or Nursing degree preferred, or Sr.CRA and/or ACRP Certification/Designation.
• Experience with Phase I–IV clinical trials is preferred.
• Thorough knowledge of ICH-GCP and local regulatory requirements.
• Proficient in using EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite.
• Ability to travel up to 40-60%, depending on project assignment and geographic location of sites.
• Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams.
• Great communication and organizational skills, detailed orientation and sense of urgency are required.
• Holder of a valid driver’s license.
Working Conditions
Home-based
Regular travel is required
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We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.
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Work arrangement
Yes