Sr Cra I - New Sponsor In Fsp - Turkey

2+ years

Not Disclosed

Remote, USA

10 Nov. 8, 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 (Sr CRA I)

Location: Istanbul, Turkey
Company: Syneos Health
Travel: Up to 75% travel required

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success. By translating clinical, medical affairs, and commercial insights into meaningful outcomes, we address the modern challenges of the healthcare market.

At Syneos Health, the customer and patient are at the center of everything we do. We continuously look for ways to simplify and streamline our work to make Syneos Health not only easier to work with, but also a great place to work.

Whether you join us in a Functional Service Provider (FSP) partnership or a Full-Service environment, you’ll be part of a team of passionate problem solvers, driving innovation to help our customers achieve their goals. We are agile, motivated, and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Join us and discover why our 29,000 employees across 110 countries say: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?

At Syneos Health, we are committed to developing our people through career development, training, and progression. We offer supportive management, peer recognition, and a total rewards program that values your contributions.

Our Total Self culture celebrates individuality, and we are dedicated to creating a work environment where everyone feels they belong. We believe diversity—of thought, experience, and background—drives innovation and helps us build the company we all want to work for.

Job Responsibilities

As a Senior Clinical Research Associate I (Sr CRA I), you will play a pivotal role in managing and monitoring clinical trial sites to ensure compliance with regulatory standards, ICH-GCP guidelines, and study protocols. Key responsibilities include:

Site Management & Monitoring:
- Perform site qualification, initiation, interim monitoring, and close-out visits—both on-site and remotely.
- Evaluate site performance, escalate critical issues, and recommend actions to resolve problems.
- Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.
Informed Consent & Patient Safety:
- Oversee the informed consent process, ensuring it is executed and documented correctly.
- Protect patient confidentiality and monitor for safety concerns and data integrity issues, including protocol deviations and pharmacovigilance matters.
Data Review & Quality Control:
- Conduct Source Document Reviews and verify that clinical data entered into Case Report Forms (CRFs) is complete and accurate.
- Resolve queries, provide site staff guidance, and drive query resolution to closure within the agreed timelines.
- Ensure compliance with electronic data capture (EDC) systems.
Investigational Product (IP) Management:
- Monitor investigational product (IP) inventory, reconcile stock, and ensure proper storage, labeling, and security.
- Verify that IP is dispensed and administered according to study protocols and applicable regulations.
Documentation & Compliance:
- Review and maintain the Investigator Site File (ISF) for accuracy and completeness.
- Reconcile the ISF with the Trial Master File (TMF) and ensure that documents are archived according to regulatory standards.
- Record and document study activities (e.g., confirmation letters, trip reports, communication logs) as per the Clinical Monitoring Plan (CMP) and Site Management Plan (SMP).
Project Coordination & Communication:
- Understand the scope, budgets, and timelines of clinical trials, managing site-level activities to meet project objectives.
- Act as the primary liaison with site personnel, supporting site staff and ensuring timely completion of study deliverables.
- Communicate site-specific challenges and opportunities with the project team and proactively manage site expectations.
Audit & Compliance Readiness:
- Ensure sites are prepared for regulatory audits, maintaining audit readiness at all times.
- Support preparation for audits and implement follow-up actions to maintain compliance.
Training & Mentorship:
- Mentor and provide training to junior CRAs.
- Support the training and development of other clinical operations team members.
Real World Late Phase (RWLP):
- Support Real World Late Phase (RWLP) studies throughout the lifecycle, from site identification to close-out.
- Engage in chart abstraction and data collection, and collaborate with Sponsor affiliates and medical science liaisons.
Operational Improvements & Site Suggestions:
- Identify operational efficiencies and suggest process improvements to enhance study execution.
- Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy, and healthcare provider (HCP) networks.
Regulatory Compliance & Documentation:
- Collaborate with the RWLP Regulatory team to ensure that study protocols and informed consent forms are compliant with local regulations.
- Participate in bid defense meetings and provide input into proposals as needed.

Qualifications

Education:
- Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.
Experience:
- 4+ years of experience as a Clinical Research Associate (CRA), including significant experience in site management and monitoring.
- Familiarity with Good Clinical Practice (GCP), ICH Guidelines, and other relevant regulations.
- Experience in Real World Late Phase studies is advantageous.
Skills:
- Proficiency with clinical trial management systems and other clinical research tools.
- Strong communication, presentation, and interpersonal skills.
- Ability to handle complex clinical data and manage site-level challenges effectively.
Language:
- Fluency in Turkish and English is required.
Travel:
- Ability to travel up to 75% within Turkey for site monitoring visits.

Get to Know Syneos Health

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, impacting more than 675,000 trial patients globally.

Whether you are in a clinical role or part of our operations team, at Syneos Health, you will be empowered to challenge the status quo and help deliver therapies that make a real difference in the lives of patients.