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Sr Cra I (Estonia) - Sponsor-Dedicated

2+ years
Not Disclosed
10 Nov. 23, 2024
Job Description
Job Type: Remote Education: RN/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

Job Title: Senior Clinical Research Associate I (Estonia, Single-Sponsor)

Company: Syneos Health®


Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, committed to accelerating customer success by translating unique clinical, medical affairs, and commercial insights into real-world outcomes. We focus on putting the customer and patient at the center of everything we do, continuously striving to simplify and streamline our work processes. With a global workforce of over 29,000 employees across 110 countries, we are agile and driven by a passion to change lives.

Why Syneos Health

  • Employee Development: We emphasize career growth through training, progression, and recognition, alongside a comprehensive rewards program.
  • Inclusive Culture: Our Total Self culture celebrates authenticity and diversity, making Syneos Health a place where all employees can feel supported and included.
  • Global Impact: We are building a company that values diverse thoughts and perspectives, enabling us to create a meaningful impact for our customers and communities.

Job Responsibilities

Site Management and Monitoring

  • Site Qualification & Monitoring: Perform site qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with regulatory standards (ICH-GCP, Good Pharmacoepidemiology Practice) and study protocols.
  • Risk Assessment and Issue Resolution: Use judgment and experience to evaluate site performance and communicate/escalate issues to the project team. Develop action plans and resolve issues in a timely manner.
  • Informed Consent: Ensure proper informed consent process is followed and documented for all study subjects, safeguarding patient confidentiality and data integrity.
  • Clinical Data Management:
    • Review and verify the accuracy of clinical data entered in case report forms (CRFs) and site source documents.
    • Utilize query resolution techniques and provide guidance to site staff to ensure data integrity.
    • Monitor compliance with electronic data capture systems.

Investigational Product (IP) Management

  • Inventory & Compliance: Perform investigational product inventory and reconciliation. Ensure IP is stored, dispensed, and administered per the protocol.
  • Blinded Information & Regulatory Compliance: Ensure proper labeling, importation, and release of IP in compliance with local regulations.

Site File Management

  • Investigator Site File (ISF) Review: Routinely review ISF for completeness and accuracy. Reconcile ISF contents with the Trial Master File (TMF).
  • Document Archiving: Ensure sites comply with regulatory guidelines for document archiving.

Project Coordination & Support

  • Project Scope & Timeline Management: Understand project scope, budgets, and timelines. Manage site-level activities and communication to ensure project objectives are met.
  • Training & Compliance: Ensure that site staff is trained on study requirements. Act as primary liaison between project team and site personnel.
  • Audit Readiness: Provide guidance to sites and project teams to ensure audit readiness and assist with preparation and follow-up actions.

Real World Late Phase (RWLP)

  • Site Lifecycle Support: Manage site activities from site identification through close-out for Real World Late Phase studies.
  • Local Knowledge: Provide insights into local treatment patterns, patient advocacy, and Health Care Provider (HCP) associations to identify and suggest potential sites.
  • Collaboration: Work with sponsors, affiliates, medical science liaisons, and local country staff to support data collection and chart abstraction activities.
  • Regulatory Compliance: Collaborate with RWLP regulatory teams to ensure up-to-date regulatory information is applied.
  • Training & Mentorship: Train junior CRA staff and lead site training initiatives.

Other Responsibilities

  • Bid Defense: Participate in bid defense meetings and provide input on project proposals.
  • Process Improvement: Identify and suggest operational efficiencies and process improvements for site management and clinical monitoring.

Qualifications

Education and Experience

  • Education: Bachelor’s degree or Registered Nurse (RN) in a related field, or an equivalent combination of education, training, and experience.
  • Experience:
    • In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and other applicable regulatory requirements.
    • Strong understanding of clinical research processes and site management.
    • Proven ability to manage multiple sites and projects effectively.

Skills and Competencies

  • Technical Skills: Proficiency with clinical data management systems, electronic data capture, and relevant software.
  • Communication Skills: Excellent verbal and written communication skills, with the ability to engage stakeholders at all levels.
  • Critical Thinking: Ability to apply basic critical thinking skills to solve problems and address issues effectively.
  • Travel: Ability to manage required travel of up to 75% regularly.

Additional Information

  • The duties outlined in this job description are not exhaustive and may evolve as required by the company.
  • Syneos Health may assign other responsibilities at its discretion.
  • Equivalent experience, skills, or education may be considered in lieu of the listed qualifications.
  • Syneos Health is committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations when necessary.

About Syneos Health

Over the past 5 years, Syneos Health has partnered with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites, involving over 675,000 trial patients. Join Syneos Health and make a meaningful impact on global healthcare.