Senior Cra - Sponsor Dedicated, Full-Service

5+ years

Not Disclosed

Remote - Europe

10 Sept. 9, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Senior Clinical Research Associate I

Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage our expertise across clinical, medical affairs, and commercial sectors to address modern market realities and streamline our processes, enhancing both our partnerships and workplace.

Join Us: At Syneos Health, our Clinical Development model centers on the customer and the patient. We are constantly innovating to simplify and improve our work, making us an exceptional place to both work with and for. Collaborate with a global team of passionate problem-solvers to drive the delivery of impactful therapies.

Why Syneos Health:

Career Development: We are committed to your professional growth through career progression, supportive management, and extensive training.
Total Self Culture: Embrace your authentic self in a culture that values diversity and inclusion, fostering a sense of belonging for everyone.
Innovation and Inclusion: Join a company that continually strives to create a dynamic workplace where diverse perspectives and experiences are celebrated.

Job Responsibilities:

Site Management: Conduct site qualification, initiation, monitoring, management, and close-out visits (on-site or remotely). Ensure adherence to regulatory standards, ICH-GCP, and protocol requirements. Evaluate site performance and develop action plans for serious issues, maintaining a working knowledge of applicable guidelines and regulations.
Informed Consent: Verify that informed consent processes are correctly performed and documented, ensuring patient confidentiality and addressing safety and data integrity issues.
Data Verification: Assess site processes, conduct source document reviews, and ensure the accuracy and completeness of data in case report forms (CRFs). Resolve queries, provide guidance, and ensure compliance with electronic data capture requirements.
Investigational Product (IP) Management: Oversee IP inventory, reconciliation, storage, and security. Verify compliance with protocol regarding IP dispensing and handling. Ensure proper labeling, importation, and return of IP.
Document Management: Review and reconcile Investigator Site File (ISF) with Trial Master File (TMF). Ensure compliance with archiving requirements and maintain accurate documentation of site activities.
Recruitment and Retention: Support patient recruitment, retention, and awareness strategies. Track observations and action items, and document activities as required.
Project Management: Understand project scope, budgets, and timelines. Manage site-level activities and communications to meet objectives and adapt to changing priorities.
Liaison and Training: Act as a primary liaison with study site personnel, ensure compliance with training requirements, and prepare for and attend investigator meetings and sponsor face-to-face meetings.
Audit Readiness: Guide site and project-level audit readiness and support preparation and follow-up actions.

Additional Responsibilities for Real World Late Phase (RWLP) Studies:

Support site activities from identification to close-out.
Understand local requirements for RWLP study designs.
Perform chart abstraction and data collection.
Collaborate with sponsors, medical science liaisons, and local staff.
Train junior staff and suggest potential sites based on local knowledge.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Proficiency with technology and data management tools.
Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel regularly.

Get to Know Syneos Health: In the past five years, we have contributed to 94% of all Novel FDA-Approved Drugs, 95% of EMA-Authorized Products, and over 200 studies across 73,000 sites with 675,000+ trial patients. Join us to challenge the status quo and make a significant impact in a competitive and evolving field.

Additional Information: This job description is not exhaustive and may be subject to change. Qualifications may vary based on equivalent experience. Syneos Health is committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations as needed.

Apply Now: Explore this opportunity and others by joining our Talent Network to stay connected with future career possibilities at Syneos Health.

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Senior Cra - Sponsor Dedicated, Full-Service

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