Cra Ii - New Sponsor - Fsp - Based In Istanbul

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 (CRA)

Location: Netherlands
Company: Syneos Health
Travel: Frequent travel across the Netherlands for monitoring visits

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We combine unique clinical, medical affairs, and commercial insights to deliver outcomes that address the evolving realities of today’s market.

Our Clinical Development model places both the customer and the patient at the center of everything we do. By simplifying and streamlining our processes, we aim to not only make Syneos Health easier to collaborate with, but to also create a company that’s easy to work for.

Whether working in a Functional Service Provider (FSP) partnership or within a Full-Service environment, you’ll work alongside passionate problem solvers to drive innovation and deliver impactful therapies. At Syneos Health, we are agile, and driven to accelerate the delivery of life-changing therapies.

Join us, and discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?

At Syneos Health, we are passionate about developing our people through career growth, training, mentorship, and a strong commitment to personal well-being. We offer a Total Self culture, where you can authentically be yourself, supported by engaging leadership and a diverse and inclusive team.

Our culture unites us globally, and we are dedicated to creating an environment where everyone feels valued and empowered. Join us to build the company we all want to work for, and the one our clients trust to work with.

Job Responsibilities

As a Senior Clinical Research Associate (CRA), you will be responsible for overseeing site management activities throughout the study lifecycle. This includes managing site qualification, initiation, monitoring, and close-out visits, ensuring that studies are conducted according to regulatory standards, ICH-GCP guidelines, and protocol requirements.

Site Monitoring & Management:
- Conduct site qualification, initiation, monitoring, and close-out visits (both on-site and remotely).
- Ensure compliance with regulatory requirements, ICH-GCP guidelines, and study protocols.
- Utilize professional judgment to evaluate site performance, escalating issues when necessary, and developing corrective action plans.
Informed Consent & Patient Safety:
- Ensure informed consent is appropriately obtained and documented for each participant.
- Safeguard patient confidentiality and assess potential risks to patient safety and clinical data integrity, including protocol deviations or pharmacovigilance concerns.
Source Document Review & Data Accuracy:
- Review source documents and medical records to verify the accuracy and completeness of clinical data entered in the Case Report Form (CRF).
- Resolve data queries remotely and on-site, providing guidance to site staff as needed.
Investigational Product (IP) Management:
- Manage investigational product inventory and reconciliation.
- Ensure IP is dispensed and administered per the study protocol, with appropriate labeling, storage, and security.
Documentation & Compliance:
- Regularly review the Investigator Site File (ISF) for completeness and timeliness, reconciling it with the Trial Master File (TMF).
- Ensure proper archiving of essential study documents according to regulatory guidelines.
- Document all site visit activities, including confirmation letters, follow-up letters, trip reports, and communication logs.
Project Coordination & Communication:
- Manage site-level activities and communications to ensure study objectives, deliverables, and timelines are met.
- Act as the primary liaison with site personnel and collaborate with the central monitoring team.
- Participate in clinical monitoring meetings and Investigator Meetings, representing Syneos Health and the study sponsor as needed.
Audit Readiness & Compliance:
- Ensure sites are audit-ready by maintaining compliance with ICH-GCP and other regulatory requirements.
- Support audit preparations and follow-up actions as required.
Mentorship & Training:
- Provide guidance and mentorship to more junior CRAs.
- Assist in training new staff members and conducting site-level sign-off visits for junior staff.
Real World Late Phase (RWLP) Responsibilities:
- Manage site support throughout the study lifecycle from site identification to close-out.
- Apply knowledge of local requirements for Real World Late Phase (RWLP) study designs and regulatory compliance.
- Perform chart abstraction activities and data collection as required.
- Build relationships with sponsor teams, medical science liaisons, and other affiliates.

Qualifications

Education:
- A Bachelor’s degree in a related field or RN, or equivalent combination of education, training, and experience.
Experience:
- At least 2 years of experience as a Clinical Research Associate (CRA).
- Prior experience in Real World Late Phase (RWLP) studies is a plus.
- In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and other regulatory requirements.
- Oncology experience is an advantage.
Skills:
- Proficient in the use of clinical trial management systems and other relevant software.
- Excellent communication, presentation, and interpersonal skills.
- Strong critical thinking and problem-solving skills.
Language:
- Fluency in Dutch and proficient in English.
Travel:
- Must be willing to travel frequently across The Netherlands for site monitoring visits.

Get to Know Syneos Health

Over the past 5 years, Syneos Health has collaborated on 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and more than 200 studies across 73,000 sites, involving over 675,000 trial patients.

Whether you're in an operational role or part of the clinical team, you'll have the opportunity to make a meaningful impact, challenge the status quo, and grow with us in a dynamic and competitive industry.