Sr Cra I- Central Us- Oncology And Dermatology

2+ years

$62,000 to $145,100

Remote, USA

10 Sept. 13, 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, 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

Senior Clinical Research Associate I

Location: [Location]

Company Overview

Syneos Health® stands at the forefront of biopharmaceutical solutions, committed to accelerating customer success through a fully integrated approach. By transforming clinical, medical affairs, and commercial insights into tangible outcomes, we address contemporary market demands.

Our Clinical Development model centers on the customer and patient, continuously innovating to simplify our processes and enhance our effectiveness. Whether in a Functional Service Provider or Full-Service setting, you’ll collaborate with dedicated professionals, driving forward the delivery of life-changing therapies.

Join our global team of 29,000 employees across 110 countries and experience how: WORK HERE MATTERS EVERYWHERE

Why Syneos Health?

Career Advancement: Benefit from robust career development opportunities, supportive management, technical training, and a rewarding recognition program.
Inclusive Culture: Embrace our Total Self culture, where diversity and authenticity are celebrated, and everyone feels a sense of belonging.
Innovative Environment: Contribute to a company that thrives on diverse perspectives and continuous improvement.

Job Responsibilities

Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely). Ensure compliance with regulatory requirements, ICH-GCP, GPP, and protocol. Evaluate site performance, address serious issues promptly, and develop action plans. Stay informed about ICH/GCP Guidelines, relevant regulations, and company SOPs.
Informed Consent and Confidentiality: Ensure proper documentation of informed consent and maintain subject confidentiality. Evaluate factors affecting subject safety and data integrity, including protocol deviations and pharmacovigilance issues.
Data Review and Management: Perform Source Document Reviews, verify accuracy and completeness of clinical data entered in case report forms (CRFs), and apply query resolution techniques. Ensure compliance with electronic data capture requirements and utilize available tools for effective data review and capture.
Investigational Product (IP) Oversight: Manage IP inventory, reconciliation, and storage. Verify IP dispensation and administration according to protocol and address issues related to blinded or randomized information.
Documentation and Tracking: Review and reconcile Investigator Site Files (ISF) with Trial Master Files (TMF). Ensure proper archiving of documents and maintain thorough records of activities. Support subject recruitment and retention, and track observations and action items.
Project Management: Understand project scope, budgets, and timelines. Manage site-level activities and communication to ensure project objectives and timelines are met. Adapt to changing priorities effectively.
Training and Liaison: Act as the primary liaison with site personnel, ensuring training and compliance. Prepare for and attend Investigator and sponsor meetings. Provide guidance on audit readiness and support audit preparation and follow-up.
Mentorship and Leadership: May mentor and train junior CRAs and assist with clinical operations lead tasks under supervision. Contribute to business development and bid defense meetings.
Real World Late Phase (RWLP) Responsibilities: As Sr. Site Management Associate I, support sites throughout the study lifecycle, from identification to close-out. Manage chart abstraction and data collection, collaborate with sponsors and affiliates, and suggest potential sites based on local knowledge. Identify process improvements and contribute to regulatory updates and bid defense meetings.

Qualifications

Education: Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
Experience: Proven CRA experience with knowledge of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements. Experience in real-world late phase studies is beneficial.
Skills: Strong computer skills, excellent communication and interpersonal abilities, and a basic level of critical thinking. Ability to manage travel requirements (up to 75%).

Additional Information

COVID-19 Policy: Syneos Health encourages full COVID-19 vaccination for all employees. Some locations or clients may require proof of vaccination.
Compensation and Benefits: The annual base salary ranges from $62,000 to $145,100, based on qualifications and experience. Benefits include a company car or allowance, health coverage (medical, dental, vision), 401k match, Employee Stock Purchase Plan eligibility, performance-based bonuses, and flexible PTO. Eligibility for paid sick time varies by location, in compliance with applicable regulations.
Legal Compliance: Syneos Health adheres to all relevant employment legislation, including the EU Equality Directive and the Americans with Disabilities Act, and provides reasonable accommodations as necessary.

Be part of a team where your contributions make a significant global impact. Learn more and apply today at Syneos Health Careers.