Sr Cra I (Finland) - Sponsor-Dedicated

2+ years

Not Disclosed

Remote, USA

10 Nov. 18, 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 I (Sponsor-dedicated)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We transform clinical, medical affairs, and commercial insights into impactful outcomes to address modern market realities. Our Clinical Development model places the customer and the patient at the center of everything we do, continuously seeking ways to simplify and streamline processes.

We are passionate about accelerating the delivery of therapies and innovating as a team to help our customers achieve their goals. We offer both Functional Service Provider partnerships and Full-Service environments, collaborating with problem solvers who share the mission to change lives.

Why Syneos Health
At Syneos Health, we are dedicated to developing our people through career progression, supportive management, technical training, peer recognition, and a comprehensive rewards program. We embrace a Total Self culture, where you can authentically be yourself. This culture unites us globally and fosters a workplace where diversity, inclusion, and belonging are celebrated.

Job Responsibilities

Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, GPP, and protocol guidelines.
Evaluate site performance and provide recommendations regarding site-specific actions.
Ensure informed consent processes are properly documented and confidentiality is maintained for each subject/patient.
Assess safety risks and data integrity, including protocol deviations and pharmacovigilance issues.
Verify clinical data accuracy, assist with query resolutions, and ensure proper inventory and administration of investigational products.
Ensure compliance with site documentation, Investigator Site File (ISF), and Trial Master File (TMF) protocols.
Contribute to site recruitment, retention, and awareness strategies and document all relevant activities.
Manage site-level activities, timelines, and communication to ensure project objectives and deliverables are met.
Provide guidance on audit readiness and collaborate with the project team to resolve any issues.
May provide mentorship to junior CRAs and participate in training sessions.

Qualifications

Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements.
Strong communication and critical thinking skills.
Ability to manage up to 75% travel.

Get to Know Syneos Health
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 globally.

Additional Information
The responsibilities listed are not exhaustive, and the Company may assign other duties as necessary. Equivalent experience, skills, and/or education will also be considered.

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Sr Cra I (Finland) - Sponsor-Dedicated

Job Description

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