Senior Cra Ii - Must Have Early Phase Neurology Expereince - Sponsor Dedicated - Bulgaria (Homebased)

3-5 years

Not Disclosed

Bulgaria

10 Nov. 23, 2024

Job Description

Job Type: Full Time 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

Senior Clinical Research Associate II – Job Description

Company Overview: Syneos Health® is a global biopharmaceutical solutions organization, dedicated to accelerating customer success by translating clinical, medical, and commercial insights into outcomes that address the complexities of modern market needs. With a focus on collaboration and innovation, Syneos Health is committed to simplifying the clinical development process and making a positive impact on patients' lives.

Why Syneos Health? Syneos Health values the development of its people through career progression, technical and therapeutic training, and a supportive workplace culture. We believe in creating an inclusive environment where diversity, authenticity, and personal growth are central to success. Our employees are driven by a shared passion to change lives and help customers achieve their goals.

Key Responsibilities:

Site Management and Monitoring:
- Perform site qualification, initiation, interim monitoring, and close-out visits, ensuring regulatory compliance, adherence to ICH-GCP, and protocol guidelines.
- Evaluate site performance, provide recommendations for improvement, and escalate significant issues to the project team for resolution.
- Verify informed consent procedures, ensuring they are appropriately performed and documented.
- Assess factors impacting patient safety and clinical data integrity, including protocol deviations and pharmacovigilance issues.
Clinical Data and Compliance:
- Conduct Source Document Review (SDR) and Source Data Verification (SDV) of clinical trial records and ensure accuracy of case report form (CRF) entries.
- Address and resolve queries remotely or onsite, ensuring timely closure within agreed timelines.
- Ensure compliance with electronic data capture (EDC) requirements and review Investigator Site Files (ISF) for accuracy and completeness.
- Ensure investigational products (IP) are handled and stored according to protocols, and resolve any related issues (e.g., blinding, randomization).
Training, Supervision, and Collaboration:
- Act as the primary liaison with site personnel or collaborate with the Central Monitoring Associate.
- Ensure sites and team members are appropriately trained and compliant with study requirements.
- Mentor and provide training to junior CRAs, including conducting sign-off visits and supporting their development.
- Participate in investigator meetings and sponsor meetings to ensure alignment with study objectives and timelines.
Documentation and Reporting:
- Document all monitoring activities including trip reports, communication logs, and follow-up letters in compliance with SOPs.
- Manage data tracking systems to monitor ongoing site activities, status, and resolution of action items.
- Prepare and submit reports in line with regulatory and operational standards.
Study Lifecycle Management:
- Participate in business development proposals, scope definitions, and budgeting for clinical trials.
- Assist in the design and review of Case Report Forms (CRFs) and ensure informed consent forms are up to date and compliant with local regulations.
- Identify operational efficiencies and contribute to process improvements to enhance clinical trial execution.
Real-World Late Phase (RWLP) Responsibilities:
- Support site management throughout the study lifecycle from site identification to close-out.
- Manage local real-world late-phase studies, chart abstraction activities, and data collection.
- Collaborate with sponsors, affiliates, and local teams to align on study requirements and local regulations.

Qualifications:

Education: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
Experience: Minimum of 2-4 years of experience in clinical monitoring or site management for a contract research organization (CRO) or pharmaceutical company. Experience in late-phase or oncology studies is preferred but not required.
Skills:
- Strong knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
- Proficient in the use of clinical trial management systems (CTMS), electronic data capture (EDC), and Investigator Site Files (ISF).
- Excellent communication, presentation, and interpersonal skills.
- Strong organizational and time-management abilities.
- Proficient in using new technologies and systems.
Languages: Proficiency in English (both written and spoken). French is a plus.
Travel: Willingness to travel up to 75% for site visits and monitoring activities.

Behavioral Competencies:

Critical thinking and problem-solving skills with the ability to manage complex situations.
Ability to build and maintain relationships with site staff and other stakeholders.
Strong attention to detail and commitment to meeting project timelines.
Demonstrated ability to adapt to evolving project requirements and technologies.

Why work at Syneos Health?
At Syneos Health, you will have the opportunity to work in a dynamic, collaborative environment where you can develop your skills and make an impact on global clinical research. Join us and be a part of a company committed to improving the lives of patients and the success of our clieNTS.

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Senior Cra Ii - Must Have Early Phase Neurology Expereince - Sponsor Dedicated - Bulgaria (Homebased)

Job Description

Senior Clinical Research Associate II – Job Description

Key Responsibilities:

Qualifications:

Behavioral Competencies:

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