Sr Clinical Research Associate / Cra Ii

2+ years

$63,090 to $145,000

Remote, USA

10 Aug. 21, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Company Overview

Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We bring clinical, medical affairs, and commercial insights to address modern market realities, with a focus on patient-centered solutions. Our integrated approach and commitment to innovation drive us to simplify and streamline our processes to make Syneos Health easier to work with and for.

Why Syneos Health?

At Syneos Health, we are committed to developing our people through career growth opportunities, supportive management, and ongoing training. Our Total Self culture allows you to be authentically yourself, fostering a sense of belonging and unity across our global team. Join us and be part of a company that values diversity of thought and perspective, striving to build a place where everyone feels they belong.

Role Overview

As a Clinical Research Associate II, you will play a crucial role in managing clinical trial sites, ensuring compliance with regulatory standards, and contributing to the success of clinical studies. This role involves performing site qualification, initiation, monitoring, management, and close-out visits both on-site and remotely.

Key Responsibilities

Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with regulatory, ICH-GCP, GPP, and protocol requirements.
Informed Consent: Verify that informed consent is obtained and documented appropriately, safeguarding patient confidentiality and assessing factors affecting patient safety and data integrity.
Data Verification: Conduct Source Document Reviews, verify data accuracy in Case Report Forms (CRFs), and resolve queries to ensure data integrity and completeness.
Investigational Product (IP): Manage IP inventory, ensure proper dispensing and administration, and address issues related to blinded or randomized information.
Documentation: Review Investigator Site Files (ISFs) for accuracy and completeness, and ensure proper archiving of essential documents.
Communication: Document activities, track observations, manage site-level communication, and support recruitment and retention strategies.
Site Liaison: Act as a liaison with site personnel, ensuring compliance with project requirements and facilitating training.
Audit Readiness: Support audit preparation and follow-up actions, ensuring adherence to audit readiness standards.

Additional Responsibilities for Real World Late Phase Studies

Site Support: Provide support throughout the study lifecycle from site identification to close-out.
Local Knowledge: Utilize knowledge of local treatment patterns and healthcare provider associations to suggest potential sites.
Training and Collaboration: Train junior staff and collaborate with sponsor affiliates and local country staff.

Qualifications

Education: Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
Experience: Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
Skills: Proficiency in computer skills, strong communication, presentation, and interpersonal abilities.
Travel: Ability to manage travel requirements of up to 75% regularly.

Why Work with Us?

Syneos Health values our employees and offers a range of benefits to support work-life balance and career development. Benefits include:

Competitive Compensation: Base salary range from $63,090 to $145,000, with potential for commissions/bonuses based on performance.
Health Benefits: Comprehensive medical, dental, and vision coverage.
Retirement Plans: Company match 401(k) and participation in the Employee Stock Purchase Plan.
Paid Time Off: Flexible PTO and sick time.
Additional Perks: Possible company car or car allowance and other local benefits.

Join Us

At Syneos Health, your role matters everywhere. We encourage you to apply even if you don’t meet all the qualifications—we might be looking for someone with your unique background.

COVID-19 Vaccination Policy

We strongly encourage vaccination and comply with applicable local government requirements. Proof of vaccination may be required for certain roles.

Apply Now

Discover how your work can make an impact with Syneos Health. Explore more about our culture and career opportunities on our website.

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