Cra Ii

2+ years

Not Disclosed

Remote, USA

10 Nov. 18, 2024

Job Description

Job Type: Full Time 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/Haematology)

Location: Syneos Health® (Global)

About Syneos Health®: Syneos Health® is a global leader in fully integrated biopharmaceutical solutions, accelerating success for our customers by transforming clinical, medical affairs, and commercial insights into actionable outcomes. Our approach places the customer and patient at the heart of everything we do. Whether in a Functional Service Provider (FSP) partnership or a full-service environment, we work together to help customers achieve their goals and accelerate the delivery of therapies that change lives.

Why Join Us? At Syneos Health®, we prioritize career development and progression through training, technical and therapeutic area expertise, peer recognition, and a competitive rewards program. Our "Total Self" culture encourages authenticity and fosters an inclusive work environment where every individual feels they belong.

Role Overview: As a Clinical Research Associate (CRA), you will perform essential tasks for clinical trials in Immunology, Oncology, and Haematology, ensuring adherence to regulatory standards such as ICH-GCP, local regulations, and study protocols. Your responsibilities will include site management, monitoring activities, and ensuring patient safety and data integrity throughout the study lifecycle.

Key Responsibilities:

Site Management & Monitoring: Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote). Ensure compliance with regulatory and protocol standards.
Informed Consent & Safety: Ensure proper documentation of informed consent and maintain confidentiality of patient information. Identify and resolve potential risks or issues related to patient safety and data integrity.
Clinical Data Review: Conduct source document review and ensure accurate and complete data entry in case report forms (CRF). Resolve queries and maintain data quality.
Investigational Product (IP) Management: Verify IP handling, storage, and administration per protocol, ensuring compliance with GCP and regulations.
Tracking & Documentation: Maintain accurate site files and documentation, ensuring compliance with the Trial Master File (TMF). Support subject recruitment and retention strategies.
Collaboration & Training: Act as primary liaison with site personnel, ensuring training and compliance with study requirements. Participate in Investigator Meetings and sponsor meetings.
Audit Readiness & Reporting: Support audit preparation, ensuring adherence to audit readiness standards and follow-up actions.

For Real World Late Phase Studies, you may also:

Support study lifecycle from site identification to close-out.
Handle chart abstraction, data collection, and collaborate with Sponsor affiliates.
Train junior staff and proactively suggest potential sites.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent education/training.
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Strong computer skills with a willingness to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to travel up to 75% regularly.

Why Syneos Health®? With 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products managed by Syneos Health®, we continue to lead the way in clinical development. Our team is agile, innovative, and dedicated to improving patient outcomes.

Join Us: Discover a workplace where you can grow professionally, be part of a diverse and inclusive team, and make a real impact on the future of healthcare.

Additional Information: Syneos Health® may assign other tasks, duties, or responsibilities as required, based on the needs of the organization. Equivalent experience, skills, and education will be considered for qualifications. We are committed to compliance with all applicable laws, including the Americans with Disabilities Act, and provide reasonable accommodations where appropriate.

Apply now to make a difference in the lives of patients worldwide.

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Cra Ii

Job Description

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