Cra Ii - Sponsor Dedicated - Neuroscience

2+ years

$63,090 to $126,100

Remote, USA

10 Sept. 13, 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 II

Location: Remote (USA)

Company Overview

Syneos Health® is a premier fully integrated biopharmaceutical solutions organization dedicated to accelerating success for our customers. We leverage unique clinical, medical affairs, and commercial insights to deliver impactful outcomes and address today’s market needs. Our Clinical Development model places the customer and patient at the heart of our work, striving to streamline our processes to make Syneos Health an outstanding partner and employer.

Joining Syneos Health means collaborating with passionate professionals in a dynamic, agile environment focused on delivering therapies efficiently and effectively. With over 29,000 employees across 110 countries, we are committed to making a difference in lives globally.

Why Syneos Health?

Career Growth: We are dedicated to your career development through training, progression opportunities, peer recognition, and a comprehensive rewards program.
Inclusive Culture: Embrace our Total Self culture, where authenticity and diversity are celebrated.
Innovative Work Environment: Contribute to a company that values diverse perspectives and fosters a sense of belonging for everyone.

Job Responsibilities

Site Management: Perform site qualification, initiation, interim monitoring, and close-out visits (both on-site and remotely) to ensure compliance with regulatory requirements, ICH-GCP, GPP, and protocol. Evaluate site performance, address serious issues promptly, and develop action plans as needed. Maintain up-to-date knowledge of applicable guidelines, regulations, and SOPs.
Informed Consent and Confidentiality: Ensure informed consent processes are properly conducted and documented, protect subject confidentiality, and assess safety and data integrity at the site, including protocol deviations and pharmacovigilance issues.
Data Management: Conduct Source Document Reviews, verify accuracy and completeness of clinical data entered into case report forms (CRFs), and apply query resolution techniques both remotely and on-site. Ensure compliance with electronic data capture requirements.
Investigational Product (IP) Oversight: Manage IP inventory, reconciliation, storage, and security. Verify IP dispensation and administration according to the protocol, and handle 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 essential documents, and document activities through various project documents. Support subject recruitment, retention, and awareness strategies, and track observations and action items.
Project Management: Understand project scope, budgets, and timelines, and manage site-level activities to ensure project objectives and deliverables are met. Adapt quickly to changing priorities.
Training and Liaison: Act as the primary liaison with site personnel, ensuring training and compliance. Prepare for and attend Investigator Meetings and sponsor meetings. Provide guidance on audit readiness and support preparation and follow-up actions.
Real World Late Phase (if applicable): Support site management throughout the study lifecycle, including chart abstraction and data collection. Collaborate with sponsor affiliates, medical science liaisons, and local country staff. Train junior staff and identify out-of-scope activities.

Qualifications

Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience: Solid background as a CRA with relevant experience, particularly in oncology. Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements is essential.
Skills: Strong communication, presentation, and interpersonal skills. Proficiency in computer skills and adaptability to new technologies. Ability to manage travel requirements (up to 75%).

Additional Information

COVID-19 Policy: Syneos Health encourages employees to be fully vaccinated. Certain locations or customers may have specific vaccine requirements.
Compensation and Benefits: The annual base salary ranges from $63,090 to $126,100, dependent on qualifications and experience. Benefits include a company car or allowance, health benefits (medical, dental, vision), 401k matching, Employee Stock Purchase Plan eligibility, performance-based bonuses, and flexible PTO.
Legal Compliance: Syneos Health complies with all applicable federal, state, and municipal regulations, including those related to paid sick time.

Join us at Syneos Health and be part of a team where your work makes a global impact. For more information, visit Syneos Health Careers.