Sr Cra I - Sponsor Aligned - Healthy Volunteer Phase I

2-8 years

Not Disclosed

Remote, USA

10 Aug. 16, 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

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into actionable outcomes to meet modern market needs.

Our Clinical Development model places the customer and patient at the heart of all we do. We continuously seek ways to simplify and streamline our work, making Syneos Health easier to collaborate with and work for. Whether in a Functional Service Provider partnership or a Full-Service environment, you'll work alongside passionate problem-solvers, innovating as a team to help our customers achieve their goals. We are driven by agility and a passion for accelerating the delivery of therapies that can change 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 progression, supportive and engaged management, technical and therapeutic area training, peer recognition, and a total rewards program. Our Total Self culture allows you to be your authentic self. We unite globally under this culture, dedicating ourselves to taking care of our people. We are building the company we all want to work for, and our customers want to work with. When we bring together diverse thoughts, backgrounds, cultures, and perspectives, 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 guidelines, ICH-GCP, GPP, and protocols.
Evaluate site and staff performance, making site-specific recommendations, and immediately escalate serious issues to the project team with action plans.
Maintain working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Verify informed consent process, protecting patient confidentiality, and assessing factors affecting patient safety and clinical data integrity.
Conduct Source Document Review, verify clinical data accuracy, and guide query resolution.
Perform investigational product (IP) inventory and ensure compliance with IP protocols.
Review the Investigator Site File (ISF) for accuracy and ensure compliance with local guidelines for document archiving.
Document activities, support recruitment strategies, and manage site-level activities to meet project objectives and timelines.
Act as a primary liaison with project site personnel and ensure compliance with training and project-specific requirements.
Provide guidance for audit readiness, prepare for audits, and follow up on necessary actions.
Mentor junior CRAs and may lead clinical operations under supervision.

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 applicable regulatory requirements.
Proficiency with computers and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel up to 75% regularly.

Get to Know Syneos Health

In the last five years, we have collaborated with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites with 675,000+ trial patients. No matter your role, you’ll take the initiative and challenge the status quo with us in this highly competitive, ever-changing environment.

Additional Information:

Responsibilities and tasks outlined are not exhaustive. The Company may assign additional duties as needed.
We provide reasonable accommodations for employees and applicants to perform essential job functions as required by law.
Syneos Health has a voluntary COVID-19 vaccination policy. Certain local governments or customers may have vaccine requirements that apply to some employees, requiring proof of vaccination.

Benefits for this position include:

Company car or car allowance
Health benefits (Medical, Dental, Vision)
401k with company match
Employee Stock Purchase Plan eligibility
Bonus/commission based on performance
Flexible PTO and sick time

Salary Range: $72,540 to $145,000 annually, depending on qualifications, skills, and experience.

Apply Now
If you're not ready to apply, join our Talent Network to stay connected with additional career opportunities.

Diversity & Inclusion:
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your experience doesn't align perfectly, we still encourage you to apply. We consider transferable skills from previous roles and encourage you to join our Talent Network for future opportunities.

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