Cra Ii- Scra Ii (Melbourne/ Sydney)

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 premier integrated biopharmaceutical solutions organization committed to accelerating customer success. We leverage unique clinical, medical, and commercial insights to deliver outcomes that meet the complexities of the modern market.

Our Clinical Development model prioritizes both the customer and the patient. We continually strive to simplify our processes, making Syneos Health easier to collaborate with and a great place to work.

Join us in either a Functional Service Provider partnership or a Full-Service environment, where you’ll collaborate with dedicated problem solvers, innovating together to help our clients achieve their objectives. We are agile and passionate about expediting the delivery of therapies to improve lives.

Why Syneos Health?
We are dedicated to the growth and development of our employees, offering career advancement opportunities, supportive management, technical training, and recognition programs. Our "Total Self" culture encourages authenticity and fosters an environment where diverse perspectives are valued, creating a workplace where everyone feels they belong.

Key Responsibilities:

Conduct site qualifications, initiations, interim monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, and study protocols. Use your judgment to evaluate site performance, escalate significant issues, and develop action plans as necessary.
Ensure that informed consent processes are properly conducted and documented, while safeguarding patient confidentiality and assessing factors affecting patient safety and data integrity.
Implement the Clinical Monitoring/Site Management Plan (CMP/SMP) by:
- Evaluating site processes.
- Conducting Source Document Reviews.
- Verifying the accuracy and completeness of data entered in case report forms (CRFs).
- Resolving queries both remotely and on-site, providing guidance to site staff.
- Utilizing technology to facilitate effective data review and capture.
- Ensuring compliance with electronic data capture requirements.
Manage investigational product (IP) inventory and ensure adherence to protocols regarding dispensation and administration. Address 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 compliance with local archiving regulations.
Document activities through confirmation letters, trip reports, and other required project documentation, supporting patient recruitment and retention strategies.
Understand project scope, budgets, and timelines, managing site-level communications to achieve project objectives effectively.
Act as a primary liaison with study site personnel, ensuring that all assigned site team members are trained and compliant.
Prepare for and participate in Investigator Meetings and global project staff meetings, as well as clinical training sessions.
Maintain audit readiness and assist with audit preparations and follow-up actions.

Additional Responsibilities for Real World Late Phase (RWLP):

Provide support throughout the study lifecycle, from site identification to close-out.
Understand local requirements for real-world late phase study designs.
Engage in chart abstraction activities and data collection.
Collaborate with Sponsor affiliates, medical science liaisons, and local staff.
Train junior staff as requested and communicate out-of-scope activities to the Lead CRA/Project Manager.
Proactively suggest 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 willingness to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel requirements of up to 75%.

Get to Know Syneos Health:
In the last five years, we have worked with 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 initiative and challenging 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 complying with the Americans with Disabilities Act, providing reasonable accommodations as necessary 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!