Sr Cra I- Ophthalmology

5+ years

Preffered by Company

Remote, USA

10 Sept. 2, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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: Sofia, Bulgaria (Hybrid: Office/Remote)

About Syneos Health®

Syneos Health® is a premier biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market challenges and streamline the delivery of innovative therapies.

Our Clinical Development model places the customer and patient at the center of everything we do. We continuously seek to simplify and enhance our processes to improve our work environment and client interactions.

Join our team of passionate problem solvers and innovators who are committed to making a difference. Discover why our 29,000 employees across 110 countries know that:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

Career Development: We focus on nurturing talent through career progression, supportive management, technical training, and peer recognition.
Inclusive Culture: Our Total Self culture encourages you to be authentic and fosters a workplace where everyone feels they belong.
Company Growth: We are committed to creating a workplace that is both desirable and effective by valuing diverse perspectives and experiences.

Job Responsibilities

Conduct site qualification, initiation, monitoring, management, and close-out visits, ensuring compliance with regulatory, ICH-GCP, and GPP guidelines.
Evaluate site performance and provide recommendations; escalate serious issues and develop action plans as needed.
Verify informed consent processes and safeguard patient confidentiality.
Assess site processes, review source documents, verify data accuracy, and resolve queries.
Monitor investigational product inventory, security, and compliance with protocols.
Review the Investigator Site File (ISF) for accuracy and completeness, and ensure proper archiving.
Document activities and manage data tracking systems to monitor project progress.
Act as a liaison with project site personnel and ensure compliance with training requirements.
Prepare for and attend Investigator and sponsor meetings, and support audit readiness.
Provide training or mentorship to junior CRAs and assist in clinical operations lead tasks.

For Real World Late Phase (RWLP) studies:

Support site management from identification through close-out.
Conduct chart abstraction, data collection, and collaborate with sponsors and local staff.
Suggest sites based on local knowledge and contribute to process improvements.

Qualifications

Bachelor’s degree or RN in a related field or equivalent combination of education and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
Proficiency in computer skills and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills, with basic critical thinking abilities.
Ability to travel up to 75% regularly.

Additional Information

Salary: $62,000 to $145,100 annually, based on qualifications and experience.
Benefits: Includes a company car or car allowance, health benefits (medical, dental, vision), 401k match, Employee Stock Purchase Plan, performance-based bonuses, and flexible PTO.
COVID-19 Policy: Vaccination is strongly encouraged. Employees may need to comply with local vaccine requirements and provide proof of vaccination.

Apply Now

At Syneos Health, we are dedicated to creating an environment where our people can thrive and advance. Explore how you can make an impact with us. Learn more about Syneos Health and apply today!

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Sr Cra I- Ophthalmology

Job Description

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