Cra Ii - Must Have Immuno-Inflammation (Copd) Expereince - Sponsor Dedicated - Bulgaria (Homebased)

2+ years

Not Disclosed

Remote, USA

10 Nov. 20, 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 - Home Based, France

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We transform clinical, medical affairs, and commercial insights into outcomes that address the modern realities of the healthcare landscape.

Our Clinical Development model places the customer and the patient at the center of everything we do. We are constantly exploring ways to simplify and streamline our processes, making Syneos Health easier to work with and making us a great place to work for our team members.

Whether you join us in a Functional Service Provider partnership or in a Full-Service environment, you will collaborate with passionate, innovative problem-solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Why Syneos Health?

We are committed to developing our people through career growth, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages authenticity, fostering a diverse and inclusive environment where every team member feels like they belong.

Job Responsibilities:

Site Monitoring & Management:
Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol. Use judgment to evaluate site performance and escalate serious issues, developing action plans as needed.
Informed Consent & Patient Safety:
Verify informed consent is properly obtained and documented for each subject/patient. Ensure patient confidentiality is protected and assess factors that affect patient safety and data integrity, such as protocol deviations, violations, and pharmacovigilance issues.
Data Accuracy & Compliance:
Conduct Source Document Reviews and verify the accuracy and completeness of clinical data entered in case report forms (CRFs). Resolve queries remotely and on-site, providing guidance to site staff and ensuring timely closure.
Investigational Product (IP) Management:
Manage investigational product (IP) inventory, reconciliation, and storage. Ensure proper dispensing, administration, and security of IP according to the protocol and regulations.
Documentation & Reporting:
Maintain accurate records of activities, including confirmation letters, trip reports, and communication logs, in compliance with SOPs and the Clinical Monitoring Plan/Site Management Plan. Support recruitment, retention, and awareness strategies for subject/patient enrollment.
Project Management:
Monitor project scope, budgets, and timelines for assigned activities. Manage site-level communications to ensure project objectives are met and adapt to changing priorities as necessary.
Liaison & Training:
Serve as the primary liaison with site personnel and ensure that sites are trained and compliant with project-specific requirements. Attend and contribute to Investigator Meetings and sponsor meetings.
Audit Readiness & Compliance:
Ensure audit readiness and assist sites with preparation for audits and required follow-up actions.
Real World Late Phase (RWLP) Responsibilities:
Provide site support throughout the study lifecycle, from site identification through close-out. Assist with knowledge of local requirements for real world late-phase study designs, including chart abstraction activities and data collection.
- Proactively suggest sites based on local knowledge of treatment patterns and collaborate with Sponsor affiliates, medical science liaisons, and country staff.
- Identify and communicate out-of-scope activities to Lead CRA/Project Manager and may train junior staff.

Qualifications:

Education: Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
Experience: Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
Skills: Proficient computer skills with an ability to adapt to new technologies. Excellent communication, presentation, and interpersonal skills.
Travel: Willingness to travel up to 75% regularly.

About Syneos Health

Over the last five years, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites, involving over 675,000 trial patients.

At Syneos Health, you’ll take the initiative to drive change and deliver therapies faster, helping patients worldwide. If you’re ready to make a difference in clinical development, join us.

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Cra Ii - Must Have Immuno-Inflammation (Copd) Expereince - Sponsor Dedicated - Bulgaria (Homebased)

Job Description

Why Syneos Health?

Job Responsibilities:

Qualifications:

About Syneos Health

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