Sponsor Dedicated Cra Ii

2+ years

Not Disclosed

Remote, USA

10 Sept. 30, 2024

Job Description

Job Type: Remote 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

Job Title: Clinical Research Associate II

Company: Syneos Health®
Syneos Health is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform clinical, medical, and commercial insights into outcomes that address modern market challenges.

Our Clinical Development model places the customer and patient at the heart of everything we do. We continually seek ways to simplify and streamline our processes to enhance collaboration and efficiency, making Syneos Health a great place to work and partner with.

Why Syneos Health?
We are passionate about developing our employees through career growth opportunities, supportive management, specialized training, and recognition programs. Our Total Self culture fosters authenticity and a sense of belonging, allowing us to build a workplace that values diverse thoughts, backgrounds, and perspectives.

Key Responsibilities:

Conduct site qualification, initiation, interim monitoring, management activities, and close-out visits, ensuring compliance with regulatory standards, ICH-GCP, and study protocols.
Verify informed consent processes, maintaining confidentiality and assessing factors affecting patient safety and data integrity.
Follow the Clinical Monitoring/Site Management Plan (CMP/SMP) to:
- Assess site processes and perform Source Document Reviews.
- Ensure accuracy and completeness of clinical data entered in case report forms (CRFs).
- Resolve queries effectively and guide site staff towards closure.
- Ensure compliance with electronic data capture requirements.
Manage investigational product (IP) inventory and verify adherence to protocol for IP dispensing and administration.
Review the Investigator Site File (ISF) for accuracy and reconcile with the Trial Master File (TMF).
Document monitoring activities in compliance with SOPs and Clinical Monitoring Plans, supporting patient recruitment and retention strategies.
Understand project scope, budgets, and timelines, managing site-level communications to meet project objectives.
Act as a liaison with study site personnel, ensuring training and compliance among site team members.
Prepare for and participate in Investigator Meetings and global project staff meetings.
Support audit readiness standards and assist in audit preparations and follow-ups.
Maintain up-to-date knowledge of ICH/GCP guidelines and complete required training.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
Prior monitoring experience, including all visit types (SIV to close-out), preferably in a CRO or Pharma setting.
Strong computer skills and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Willingness to travel up to 50% regularly.

About Syneos Health:
In the past five years, we have collaborated on 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and managed over 200 studies involving more than 675,000 trial patients across 73,000 sites.

At Syneos Health, every role is an opportunity to challenge the status quo and drive change in a competitive, evolving environment.

Additional Information:
This job description is not exhaustive and may be subject to change at the company's discretion. The company reserves the right to assign additional tasks and responsibilities as necessary. We are committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations to assist employees or applicants in performing essential job functions.

Join us at Syneos Health, where your work truly matters!

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Sponsor Dedicated Cra Ii

Job Description

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