Sr Cra I

2+ years

$72,540 to $145,000

Remote, USA

10 Sept. 17, 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: Senior Clinical Research Associate I

Company: Syneos Health®

Location: Various Locations (Home-Based / Hybrid / Office-Based)

About Syneos Health:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, dedicated to accelerating customer success through unique clinical, medical affairs, and commercial insights. Our Clinical Development model places both the customer and patient at the center of everything we do. We are committed to simplifying and streamlining our work to enhance both our client and employee experiences.

Why Join Us?

Career Development: We invest in our people through career advancement opportunities, supportive management, technical training, peer recognition, and comprehensive rewards programs.
Culture: Embrace our Total Self culture, where diversity of thoughts, backgrounds, and perspectives are valued, creating a workplace where everyone feels they belong.
Impact: With 29,000 employees across 110 countries, our work matters everywhere. We’re passionate about accelerating the delivery of therapies to change lives.

Job Responsibilities:

Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) ensuring compliance with regulatory, ICH-GCP, and protocol standards. Evaluate site performance, communicate serious issues, and develop action plans as needed.
Informed Consent: Verify the informed consent process and ensure confidentiality and safety of subjects/patients. Assess factors affecting patient safety and data integrity.
Data Review: Review source documents and medical records, verify clinical data accuracy, and resolve queries. Ensure compliance with electronic data capture requirements.
Investigational Product (IP): Monitor IP inventory, reconciliation, and ensure proper storage, security, and handling according to protocol.
Documentation: Maintain accurate and timely records of site activities, including Investigator Site File (ISF) and Trial Master File (TMF). Support subject recruitment, retention, and awareness strategies.
Project Management: Understand project scope, budgets, and timelines. Manage site-level activities to meet project objectives. Adapt to changing priorities and contribute to audit readiness.
Training & Mentorship: Provide training and mentorship to junior CRAs and participate in clinical training sessions and meetings.

Qualifications:

Education: Bachelor’s degree or RN in a related field or equivalent combination of education and experience.
Experience: Demonstrated knowledge of Good Clinical Practice (GCP) and ICH Guidelines. At least 2 years of relevant experience preferred.
Skills: Excellent communication, presentation, and interpersonal skills. Proficiency with computer systems and new technologies. Ability to manage up to 75% travel.
Additional: Basic critical thinking skills and experience in managing multiple projects simultaneously.

Additional Responsibilities (Real World Late Phase):

Support site activities from identification through close-out.
Knowledge of local requirements for late-phase study designs.
Engage in chart abstraction, data collection, and collaboration with Sponsors and affiliates.
Identify operational efficiencies and process improvements.

Benefits:

Compensation: Annual base salary ranges from $72,540 to $145,000, based on qualifications and experience.
Perks: Company car or car allowance, health benefits (Medical, Dental, Vision), 401k match, Employee Stock Purchase Plan, performance-based commissions/bonus, flexible PTO, and sick time.

COVID-19 Policy:

Syneos Health encourages COVID-19 vaccination and adheres to local government or customer requirements. Proof of vaccination may be required.

Equal Opportunity Employer:

Syneos Health is an equal opportunity and inclusive employer, committed to providing a workplace free from discrimination and harassment. We welcome applications from all qualified individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Interested?

If you’re ready to make an impact and advance your career, apply now at Syneos Health Careers.

Note: Job responsibilities and qualifications are subject to change based on company needs and project requirements. Syneos Health complies with all applicable federal, state, and municipal regulations.

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Sr Cra I

Job Description

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