Sr Cra Ii (Sponsor Dedicated)

4+ years

Not Disclosed

Remote - Europe

10 July 17, 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, 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 II

Company:
Syneos Health

Location:
Global

About Syneos Health:
Syneos Health® is a leading biopharmaceutical solutions organization focused on accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model prioritizes customers and patients, continuously simplifying and streamlining our work to enhance collaboration and effectiveness. Join us in a Functional Service Provider partnership or a Full-Service environment to work with passionate problem solvers and help our customers achieve their goals.

Why Work at Syneos Health:

Passionate about developing people through career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Commitment to a Total Self culture, promoting authenticity and well-being
Diverse and inclusive workplace

Job Responsibilities:

Perform site qualification, initiation, interim monitoring, site management, and close-out visits, ensuring regulatory and protocol compliance.
Evaluate site performance and provide recommendations; communicate serious issues to the project team and develop action plans.
Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Verify informed consent processes and documentation, ensuring subject/patient confidentiality.
Assess factors affecting subject/patient safety and clinical data integrity, addressing protocol deviations and pharmacovigilance issues.
Conduct Source Document Review and ensure clinical data accuracy in case report forms (CRFs).
Apply query resolution techniques and provide guidance to site staff.
Verify compliance with electronic data capture requirements and manage investigational product (IP) inventory and reconciliation.
Review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF).
Document activities and support recruitment, retention, and awareness strategies.
Enter data into tracking systems and manage site-level activities to meet project objectives and timelines.
Liaise with study site personnel and ensure compliance with applicable requirements.
Attend Investigator Meetings and sponsor meetings, participating in clinical training sessions.
Provide guidance for audit readiness and support audit preparations.
Mentor and supervise junior CRAs, performing training and sign-off visits.
Participate in business development proposals and defense meetings.
For Real World Late Phase (RWLP), additional responsibilities include site support, chart abstraction, and data collection.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
Proficiency with computer skills and ability to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Moderate level of critical thinking skills.
Ability to manage travel up to 75% regularly.

Additional Information:

Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Tasks, duties, and responsibilities listed are not exhaustive. The company may assign other tasks and job responsibilities at its discretion.
Equivalent experience, skills, and/or education will be considered, and the company will determine what constitutes equivalence.
This job description does not create an employment contract.
The company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations as appropriate.

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At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We consider transferrable skills from previous roles and encourage you to join our Talent Network for additional career opportunities.

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