Sr Clinical Research Associate (Portugal)

OpenKrill; United States; Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Education Reimbursement

Cell Phone Allowance

Office setup allowance

Visiting program

Flexible Summer Hours

Employee referral program

Alimentiv Trust eligibility

Mentorship program

Résumé du poste

Alimentiv is seeking a Senior Clinical Research Associate to independently manage site monitoring and site management across Portugal and Spain, from start-up to close-out. You will serve as the main contact for investigative sites, ensuring protocol adherence, ICH-GCP compliance, and study requirements while supporting high-quality data and study delivery.

This senior role includes mentoring junior CRAs, guiding cross-functional teams, and collaborating with sponsors to meet timelines.

Qualifications

• Bachelor's degree in Life Sciences or related field; Master's preferred.
• 4-6 years clinical research experience; 7-9 years preferred.
• Strong site monitoring across trial phases from start-up to close-out.
• Thorough knowledge of ICH-GCP and local regulatory requirements.
• Experience with Phase I-IV trials preferred.
• Proficiency with EDC, IRT, eTMF, CTMS; Medidata Rave/Oracle InForm preferred.
• Strong site management including activation, recruitment, and training.
• Excellent communication and relationship-management skills.
• Willingness to travel 40-60%; valid driver's license.
• Fluent written and verbal English and Spanish.

Responsabilités

• Independently conduct and document onsite and remote monitoring across Portugal and Spain.
• Ensure sites comply with protocols, ICH-GCP, and SOPs.
• Act as primary site contact; manage questions, deviations, and action items.
• Review data, source docs, and study systems for accuracy and integrity.
• Support site selection, activation, and recruitment to milestones.
• Train sites on protocols and study systems throughout the lifecycle.
• Maintain ISF and TMF documentation; timely filing.
• Collaborate with sponsors, teams, vendors to support timelines.
• Participate in audits, Investigator Meetings, and project activities.
• Mentor CRA I/II; contribute to process improvements.

Connaissances

Clinical monitoring

ICH-GCP knowledge

Site management

Data integrity

Cross-functional collaboration

Mentoring/coaching

Travel readiness

English fluency

Spanish fluency

Driver's license

EDC/CTMS proficiency

Medidata Rave

Oracle InForm

Formation

Bachelor's degree in Life Sciences

Master's degree preferred

Outils

Medidata Rave

Oracle InForm

EDC

CTMS

Description du poste

Job Overview

As a Senior Clinical Research Associate, you will play a key role in the successful delivery of clinical trials by independently managing clinical site monitoring and site management activities across Portugal and Spain, from study start-up through close-out. You will act as a primary point of contact for investigative sites in these countries, ensuring compliance with protocols, ICH-GCP, applicable regulations and study requirements while supporting high-quality patient data and study delivery.

This is a senior individual contributor role with responsibility for supporting site performance, resolving issues, maintaining study documentation and providing guidance and mentorship to junior CRAs. You will work closely with Clinical Operations, Project Management, sponsors and other cross-functional teams in a dynamic clinical research environment.

Key Responsibilities:

• - Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits across Portugal and Spain.
• - Ensure investigative sites comply with study protocols, ICH-GCP, applicable regulations, SOPs and project-specific requirements.
• - Serve as a primary point of contact for assigned sites, managing site-related questions, issues, action items and protocol deviations through to resolution.
• - Review clinical trial data, source documentation and study systems to ensure accuracy, completeness, data integrity and compliance.
• - Support site selection, activation and recruitment activities, working with sites to achieve study milestones and patient recruitment targets.
• - Ensure sites are appropriately trained on protocols, study systems, processes and applicable requirements throughout the study lifecycle.
• - Maintain oversight of essential study documentation, including ISF and TMF, ensuring documents are complete, accurate and filed in a timely manner.
• - Collaborate with sponsors, project teams, vendors and investigative sites to support study timelines, resolve issues and maintain effective working relationships.
• - Participate in audits and inspections, Investigator Meetings, study meetings and other project activities as required.
• - Provide mentoring and support to CRA I and II colleagues, participate in co-monitoring and CRA assessment activities, and contribute to process improvement initiatives.

Skills & Qualifications

• - Bachelor's degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline; a Master's degree is preferred.
• - 4-6 years of relevant clinical research experience, with 7-9 years preferred.
• - Strong clinical site monitoring experience across clinical trial activities from site start-up through close-out.
• - Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements.
• - Experience with Phase I-IV clinical trials preferred.
• - Proficiency with clinical trial systems such as EDC, IRT, eTMF, CTMS and Microsoft Office, with experience in systems such as Medidata Rave or Oracle InForm preferred.
• - Strong understanding of site management, including site activation, recruitment, training, issue resolution and maintenance of essential documentation.
• - Excellent communication, interpersonal and relationship-management skills, with the ability to work effectively with investigative sites, sponsors and cross-functional teams.
• - Strong organisational, problem-solving and prioritisation skills, with a high level of attention to detail and a sense of urgency.
• - Ability to work independently, demonstrate sound judgement and manage competing priorities in a results-driven environment.
• - Experience mentoring or supporting junior CRAs is preferred.
• - Willingness and ability to travel approximately 40-60%, depending on project requirements and geographic location.
• - Valid driver's licence required.
• - Fluent written and verbal English and Spanish

What We OfferIn addition, as an Alimentiv Employee, you’re also eligible for the following programs:

• - Education Reimbursement program for full-time employees
• - Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
• - One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)
• - Working while visiting program – up to 4 weeks per year!
• - Flexible Summer Hours Program from May – September
• - Employee referral incentive – we know great people know other great people, and we think that warrants recognition!
• - Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment
• - Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!

Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.

Our Services

• - End-to-end GI clinical trial services, from protocol design through submission support
• - Central medical imaging management and endoscopic reading
• - Precision medicine and biomarker solutions
• - Real-world evidence and clinical consulting
• - Histopathology and lab services through AcelaBio

Equal Opportunity and AccessibilityAlimentiv is committed to building a diverse, inclusive and respectful workplace. We are an equal opportunity employer and consider all qualified applicants for employment without regard to race, colour, ethnicity, national origin, religion or belief, sex, gender identity or expression, sexual orientation, age, marital or family status, disability, or any other characteristic protected by applicable law.

Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to [e-mail].