Cra Ii / Senior Cra - Sponsor Dedicated - Bulgaria

2+ years

Not Disclosed

Remote - Europe

10 Oct. 16, 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

Description - External
Clinical Research Associate II / Senior Clinical Research Associate

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model puts the customer and the patient at the center of everything we do. We continuously seek ways to simplify and streamline our processes, making Syneos Health easier to work with and for.

Joining us in a Functional Service Provider partnership or a Full-Service environment means collaborating with passionate problem solvers, innovating as a team 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.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are dedicated to developing our people through career progression, supportive management, technical training, peer recognition, and a comprehensive rewards program. We are committed to our Total Self culture, allowing you to authentically be yourself. This culture unites us globally, and we prioritize taking care of our people. We are building the company we all want to work for, fostering diversity of thoughts, backgrounds, cultures, and perspectives, creating a place where everyone feels they belong.

Job Responsibilities

Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring compliance with regulatory, ICH-GCP, and protocol standards. Use judgment to evaluate site performance and communicate serious issues to the project team.
Verify informed consent processes are properly executed and documented for each subject. Protect confidentiality and assess factors impacting patient safety and data integrity at investigator sites.
Follow the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assess site processes and conduct Source Document Reviews.
- Ensure accuracy of data entered in case report forms (CRFs).
- Apply query resolution techniques and guide site staff.
- Utilize technology for effective data review and capture.
- Verify compliance with electronic data capture requirements.
Perform investigational product (IP) inventory and ensure compliance with labeling and safety regulations.
Review Investigator Site Files (ISF) for accuracy and reconcile with the Trial Master File (TMF). Ensure adherence to local archiving guidelines.
Document activities through confirmation letters, trip reports, and other required project documents. Support patient recruitment and retention strategies.
Understand project scope, budgets, and timelines; manage site-level communication to meet project objectives.
Act as primary liaison with study site personnel and ensure compliance with training requirements.
Attend Investigator Meetings and participate in clinical training sessions as needed.
Support audit readiness and preparation for audits.
Maintain a working knowledge of relevant guidelines and regulations and complete required training.

For Real World Late Phase, additional responsibilities include:

Support throughout the study lifecycle.
Knowledge of local requirements for real-world late phase study designs.
Collaborate with sponsors, medical science liaisons, and local staff.
Train junior staff as requested.
Propose potential sites based on local treatment patterns.

Qualifications

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

Get to Know Syneos Health

In the past five years, we've worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites with more than 675,000 trial patients.

No matter your role, you’ll take initiative and challenge the status quo in a competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks at its discretion without prior notice. Equivalent experience and skills will be considered, and qualifications may differ. Nothing herein creates an employment contract. The Company is committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations when appropriate.

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At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also invite you to join our Talent Network to stay connected to additional career opportunities.