Sr Cra I

3+ years

Not Disclosed

Remote - Europe

10 Aug. 7, 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, 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

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We convert unique clinical, medical affairs, and commercial insights into actionable outcomes to meet modern market demands.

Our Clinical Development model centers on the customer and the patient, continuously seeking to simplify and streamline our processes. This approach not only enhances our partnerships but also makes Syneos Health a desirable place to work.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with dedicated problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery 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 committed to developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters an environment where you can authentically be yourself, uniting us globally and ensuring we take care of our people.

We strive to build the company we all want to work for and our customers want to work with. When we embrace diversity of thought, background, culture, and perspective, we create a place where everyone feels they belong.

Job Responsibilities

Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring compliance with regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) standards.
Evaluate site and staff performance, provide recommendations, and communicate serious issues to the project team, developing action plans as necessary.
Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Verify informed consent processes and documentation, ensuring subject/patient confidentiality and safety.
Assess site processes, conduct source document reviews, verify clinical data accuracy, and drive query resolution.
Manage investigational product (IP) inventory, reconciliation, storage, and security, ensuring compliance with GCP/local regulations and organizational procedures.
Review Investigator Site File (ISF) accuracy, timeliness, and completeness, ensuring compliance with archiving requirements.
Document activities in accordance with SOPs and Clinical Monitoring Plan/Site Management Plan, supporting subject/patient recruitment and retention strategies.
Manage site-level activities and communication to meet project objectives, deliverables, and timelines.
Act as primary liaison with project site personnel, ensuring training and compliance.
Participate in and potentially lead global clinical monitoring/project staff meetings and training sessions.
Provide guidance for audit readiness and support audit preparations.
Mentor and train junior CRA staff as assigned.

For Real World Late Phase (RWLP) Projects

Support site activities throughout the study lifecycle.
Apply knowledge of local requirements for real world late phase study designs.
Conduct chart abstraction activities and data collection.
Collaborate with sponsors, medical science liaisons, and local country staff.
Identify and communicate out-of-scope activities.
Suggest potential sites based on local knowledge.
Identify operational efficiencies and process improvements.
Develop country-level informed consent forms.
Collaborate with RWLP Regulatory team to share updated regulatory information.
Participate in bid defense meetings.

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 other regulatory requirements.
Proficient computer skills and ability to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel requirements of up to 75% regularly.

Get to Know Syneos Health

Over the past five years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 Studies across 73,000 Sites involving 675,000+ Trial patients. Join us to take the initiative and challenge the status quo in a competitive, ever-changing environment.

Additional Information

Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks, duties, and job responsibilities at its discretion and without prior notice. Equivalent experience, skills, and/or education will be considered. The Company determines what constitutes equivalent qualifications. This job description does not create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations.

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