Senior Clinical Research Associate I

3+ years

Not Disclosed

Remote, USA

10 May 17, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Research Associate I

Location: United States-North America - USA-Michigan-Home-Based

Job ID: 24002874

Date Updated: May 9, 2024

Description:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We prioritize simplifying and streamlining our work to better serve our customers and patients.

Why Syneos Health:

We invest in our people's career development and progression.
Our Total Self culture fosters authenticity and inclusivity.
We are dedicated to building an inclusive workplace where everyone feels they belong.

Job Responsibilities:

Perform site qualification, initiation, monitoring, and close-out visits to ensure regulatory and protocol compliance.
Verify the informed consent process and assess patient safety.
Conduct source document review and ensure accuracy of clinical data.
Manage the clinical trial database and ensure compliance with electronic data capture requirements.
Review Investigator Site Files for completeness and accuracy.
Document activities and track observations to resolution.
Manage site-level activities to meet project objectives and timelines.
Serve as a primary liaison with project site personnel and provide training to junior staff as needed.

Additional Responsibilities:

Provide site support throughout the study lifecycle.
Collaborate with sponsors, medical science liaisons, and local staff.
Identify operational efficiencies and process improvements.
Participate in bid defense meetings and develop informed consent forms.

Qualifications:

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

Get to know Syneos Health:

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks as needed. Equivalent experience, skills, and/or education will also be considered. The Company will determine what constitutes equivalent qualifications. Nothing contained herein should be construed to create an employment contract.

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Senior Clinical Research Associate I

Job Description

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