Sponsor Dedicated Sr Cra I - Home Based Portugal

2+ years

Not Disclosed

Portugal

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here’s a refined version of the job description:

Position: Sponsor Dedicated Senior Clinical Research Associate I
Location: Home-Based, Portugal

Company Overview
Syneos Health® is a global leader in biopharmaceutical solutions, accelerating success for our customers through integrated clinical, medical affairs, and commercial expertise. Our innovative Clinical Development model places the customer and patient at the heart of everything we do.

We simplify and streamline processes to foster collaboration and efficiency, ensuring a dynamic and rewarding work environment. With over 29,000 employees across 110 countries, Syneos Health is committed to changing lives by delivering therapies that matter.

Why Syneos Health?

Growth and Development: We prioritize career progression, supported by engaged management, technical training, and peer recognition programs.
Diversity and Inclusion: Our Total Self culture celebrates authenticity and diverse perspectives, fostering a workplace where everyone feels they belong.
Innovation and Collaboration: Together, we create a company we love to work for and that our customers trust to partner with.

Job Responsibilities
As a Senior Clinical Research Associate, you will:

Conduct site qualification, initiation, monitoring, management, and close-out visits, ensuring compliance with ICH-GCP, GPP, and regulatory standards.
Assess and verify informed consent processes for subjects/patients.
Monitor site adherence to protocols and identify potential safety or data integrity issues.
Conduct source document review and ensure accurate case report form (CRF) data entry.
Manage investigational product (IP) inventory and verify protocol-compliant dispensing.
Review and reconcile Investigator Site File (ISF) contents with the Trial Master File (TMF).
Document activities via confirmation letters, follow-ups, trip reports, and logs.
Support recruitment, retention, and awareness strategies for study participants.
Collaborate with project teams, meeting site-specific timelines and objectives.
Provide site-level guidance for audit readiness and address any follow-up actions.
Mentor junior CRAs and contribute to training initiatives.
Act as a site management liaison and provide operational support as needed.

Additional Real World Late Phase (RWLP) Responsibilities

Assist with chart abstraction, data collection, and site support throughout the study lifecycle.
Build relationships with sponsors, medical science liaisons, and local staff.
Identify operational efficiencies and suggest process improvements.
Develop country-specific informed consent forms.
Collaborate with regulatory teams to ensure compliance.
Participate in bid defense meetings.

Qualifications

Bachelor’s degree or RN in a related field (or equivalent combination of education and experience).
Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant regulations.
Proficiency with computer technologies and willingness to embrace new tools.
Excellent communication, presentation, and interpersonal skills.
Critical thinking skills and ability to adapt to a dynamic environment.
Availability to travel up to 75%.

About Syneos Health
In the past five years, Syneos Health has supported:

94% of all FDA-approved novel drugs.
95% of EMA-authorized products.
Over 200 studies across 73,000 sites and 675,000+ trial patients.

Additional Information
This job description is not exhaustive, and additional tasks or responsibilities may be assigned based on organizational needs. Syneos Health is committed to compliance with applicable equality and employment regulations and provides reasonable accommodations to assist employees or applicants in performing essential functions.

Join Us
Be part of a dynamic team dedicated to accelerating therapies and changing lives.

Apply Now

This version keeps all relevant information while improving readability, structure, and tone for clarity and engagement. Let me know if you’d like further refinements!

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Sponsor Dedicated Sr Cra I - Home Based Portugal

Job Description

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