Cra Ii

2+ years

Not Disclosed

Remote, USA

10 Oct. 7, 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

Clinical Research Associate - Sponsor Dedicated (Immunology/Oncology/Hematology)

Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. Our Clinical Development model prioritizes both the customer and the patient in everything we do. We continuously strive to simplify and streamline our processes, ensuring Syneos Health is both easy to work with and for.

Join us in a Functional Service Provider partnership or a Full-Service environment, where you will collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, motivated by a passion for changing lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health:

We are committed to the development of our people through career progression, supportive management, comprehensive training, peer recognition, and a robust total rewards program. Our Total Self culture encourages authenticity, uniting us globally and emphasizing the importance of caring for our people. By embracing diverse thoughts, backgrounds, cultures, and perspectives, we create a workplace where everyone feels they belong.

Job Responsibilities:

Conduct site qualification, initiation, interim monitoring, management activities, and close-out visits (on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP guidelines, and study protocols. Use your judgment to evaluate site performance and escalate serious issues as needed.
Ensure informed consent is properly obtained and documented for all subjects/patients, safeguarding their confidentiality and assessing factors affecting their safety and data integrity.
In line with the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assess site processes and conduct source document reviews.
- Verify accuracy and completeness of clinical data entered in case report forms (CRFs).
- Resolve queries both remotely and on-site, guiding site staff to closure within agreed timelines.
- Ensure compliance with electronic data capture requirements.
Oversee investigational product (IP) inventory and security, ensuring proper dispensation and adherence to protocol.
Regularly review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF).
Document activities through confirmation letters, trip reports, and other required project documents, tracking observations and action items.
Understand project scope, budgets, and timelines, managing site-level activities to meet objectives and deliverables. Adapt quickly to changing priorities.
Serve as the primary liaison with study site personnel and collaborate with Central Monitoring Associates to ensure site training and compliance.
Prepare for and participate in Investigator Meetings and sponsor meetings, contributing to global project staff meetings and clinical training sessions.
Ensure audit readiness standards at the site level and assist with audit preparations and follow-up actions.
Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs, completing assigned training as necessary.

For Real World Late Phase studies, the CRA II will also:

Provide site support throughout the study lifecycle from identification through close-out.
Be knowledgeable about local requirements for real-world late-phase study designs.
Conduct chart abstraction and data collection.
Collaborate with Sponsor affiliates and local staff.
Train junior staff as requested.
Identify and communicate out-of-scope activities to the Lead CRA/Project Manager.
Proactively suggest potential sites based on local treatment patterns and healthcare provider associations.

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 applicable regulatory requirements.
Proficient computer skills and a willingness to embrace new technologies.
Strong communication, presentation, and interpersonal skills.
Ability to manage travel requirements of up to 75% on a regular basis.

Get to Know Syneos Health:

In the past five years, we have worked on 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.

No matter your role, you’ll be encouraged to take initiative and challenge the status quo in a competitive and ever-evolving environment. Learn more about what it means to work at Syneos Health.

Additional Information:

The tasks and responsibilities listed in this job description are not exhaustive. Syneos Health may assign additional duties as necessary. Equivalent experience, skills, and/or education will be considered, and the company reserves the right to determine qualifications. This description aims to comply with all relevant employment legislation, including the EU Equality Directive and the Americans with Disabilities Act, which mandates reasonable accommodations when necessary.

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