Cra Ii- Scra Ii (Perth)

2+ years

Not Disclosed

Remote, USA

10 Sept. 25, 2024

Job Description

Job Type: 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

Position: Clinical Research Associate II

Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform clinical, medical affairs, and commercial insights into impactful outcomes that respond to today’s market needs.

Our Clinical Development model puts both customers and patients at the forefront of our efforts. We continuously seek to simplify and enhance our processes, making Syneos Health easier to collaborate with and to work for.

Join us in a Functional Service Provider partnership or a Full-Service environment, where you’ll collaborate with passionate problem solvers focused on delivering results. With agility and determination, we aim to accelerate therapy delivery because we are committed to changing lives.

Discover why 29,000 employees across 110 countries say:
WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?
We prioritize the growth and development of our team members through career advancement opportunities, supportive management, technical training, and recognition programs. Our "Total Self" culture encourages authenticity and unites us globally, fostering an environment where everyone belongs.

Key Responsibilities:

Conduct site qualifications, initiations, monitoring, and close-out visits (on-site or remotely) while ensuring compliance with regulatory standards, ICH-GCP, and protocols. Utilize judgment to assess site performance, escalate serious issues, and develop action plans as needed.
Ensure informed consent processes are appropriately conducted and documented, safeguarding patient confidentiality and assessing factors that impact patient safety and data integrity.
Execute the Clinical Monitoring/Site Management Plan (CMP/SMP) by:
- Evaluating site processes.
- Conducting Source Document Reviews.
- Verifying the accuracy and completeness of data in case report forms (CRFs).
- Resolving queries both remotely and on-site, providing guidance to site staff.
- Utilizing technology to support effective data review and capture.
- Ensuring compliance with electronic data capture requirements.
Manage investigational product (IP) inventory, confirming proper dispensing and administration per protocol, and addressing any issues related to blinded or randomized information.
Review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF) and ensuring adherence to local document archiving regulations.
Document all activities through confirmation letters, trip reports, and other required project documentation. Support patient recruitment and retention strategies and maintain tracking systems for ongoing observations and action items.
Understand project scope, budgets, and timelines to manage site-level communications, ensuring project objectives are achieved efficiently.
Act as the primary liaison with study site personnel, ensuring compliance and training for all team members.
Prepare for and participate in Investigator Meetings and global clinical monitoring/project staff meetings.
Maintain audit readiness and assist with audit preparation and follow-up actions.

Additional Responsibilities for Real World Late Phase (RWLP):

Provide site support throughout the study lifecycle, from identification to close-out.
Collaborate with Sponsor affiliates and local staff, ensuring adherence to local regulations for real-world late phase studies.
Identify and communicate out-of-scope activities to the Lead CRA/Project Manager.
Recommend potential sites based on local treatment patterns and relationships with healthcare providers.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
Proficient computer skills and openness to new technologies.
Excellent communication, presentation, and interpersonal skills.
Willingness to travel up to 75% of the time.

Get to Know Syneos Health:
In the past five years, we have partnered on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, contributing to over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter your role, we encourage you to take initiative and challenge the status quo in a dynamic environment. Learn more about us at Syneos Health.

Additional Information:
This job description is not exhaustive, and responsibilities may evolve as needed. Syneos Health reserves the right to assign additional tasks. Equivalent experience and qualifications will be considered.

We are committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations as needed to support our employees and applicants in performing essential job functions.

If you’re interested in this role but may not meet every qualification, we encourage you to apply—your unique skills might be just what we need!

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Cra Ii- Scra Ii (Perth)

Job Description

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