Cra Ii

2+ years

Not Disclosed

Remote, USA

10 Nov. 11, 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

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

Location: Remote/Field-based
Travel: Up to 75%

Job Overview:

Syneos Health is seeking a Clinical Research Associate (CRA) for a Sponsor Dedicated position in the fields of Immunology, Oncology, and Hematology. This is an exciting opportunity for an experienced CRA to contribute to innovative clinical trials, directly impacting the development of therapies that improve patient outcomes. In this role, you’ll be responsible for managing and monitoring clinical trials, ensuring regulatory compliance, and overseeing site performance in the execution of clinical studies.

At Syneos Health, we are driven by a passion for improving lives and accelerating customer success. Our collaborative, dynamic, and forward-thinking approach ensures that we stay at the forefront of the industry. Join us and be part of a team that is committed to making a difference in patients' lives.

Key Responsibilities:

Site Management: Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely) while ensuring compliance with ICH-GCP, regulatory requirements, and protocol.
Risk Management: Evaluate site performance, identify risks, and provide solutions. Escalate serious issues to the project team and develop corrective action plans.
Informed Consent & Patient Safety: Verify that informed consent has been obtained and documented properly for each patient, maintaining patient confidentiality. Assess safety risks and resolve clinical data integrity issues.
Data Verification & Query Resolution: Review source documents and medical records, ensuring accurate and complete data entry in the case report form (CRF). Apply query resolution techniques and guide site staff to close queries within agreed timelines.
Investigational Product Management: Manage investigational product (IP) inventory, reconciliation, and ensure proper storage and dispensation as per protocol.
Site Documentation: Maintain and verify the accuracy and completeness of the Investigator Site File (ISF) and ensure compliance with local regulatory guidelines for archiving essential documents.
Study Coordination: Assist in subject/patient recruitment, retention, and awareness strategies. Manage project scope, budgets, and timelines, ensuring site-level activities align with study objectives and milestones.
Audit Readiness: Provide guidance for maintaining audit readiness standards at the site and project level.
Training & Support: Participate in investigator meetings and sponsor meetings, and provide training to junior staff when required. May act as a liaison between the sponsor and study site personnel.
Late Phase Study Support (Real World Studies): Support study activities, including site identification, chart abstraction, data collection, and collaboration with local and global teams.

Qualifications & Skills:

Education: Bachelor’s degree or RN in a related field (or equivalent combination of education, training, and experience).
Experience: Prior experience in clinical research, with a solid understanding of ICH-GCP guidelines, and clinical trial monitoring.
Specialization: Experience in Immunology, Oncology, or Hematology is preferred.
Skills: Excellent communication, organizational, and interpersonal skills. Strong computer skills and the ability to learn and adopt new technologies.
Travel: Ability to manage travel of up to 75% on a regular basis.

Why Syneos Health:

Career Development: Syneos Health is committed to developing our employees through continuous career progression, training, and recognition.
Culture of Inclusion: We value diversity and strive to create an environment where all employees feel empowered to bring their authentic selves to work.
Comprehensive Benefits: We offer competitive pay, performance-based incentives, 401(k), health and welfare benefits, tuition reimbursement, and more.
Global Impact: Join over 29,000 employees across 110 countries who are working to accelerate the delivery of therapies that change lives.

Additional Information:

This job description is intended to provide a general overview of the responsibilities and qualifications for the Clinical Research Associate position. The company reserves the right to modify the responsibilities, tasks, and qualifications based on business needs. We are an Equal Opportunity Employer and comply with applicable legislation in all countries where we operate.