Cra Ii - Scra Ii (Perth/ Adelaide)

2+ years

Not Disclosed

Remote

10 Oct. 22, 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

Clinical Research Associate II

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 outcomes that address modern market realities.

Our Clinical Development model centers on the customer and patient, continuously seeking ways to simplify and streamline our work. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

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

Why Syneos Health?

Career Development: We invest in your growth through career progression, supportive management, training, and peer recognition.
Total Self Culture: Our inclusive culture encourages you to be your authentic self, fostering a sense of belonging.
Diversity: We believe that diverse thoughts, backgrounds, and perspectives create a workplace where everyone feels valued.

Key Responsibilities:

Perform site qualification, initiation, interim monitoring, management activities, and close-out visits (on-site or remotely) while ensuring compliance with regulatory standards and protocols.
Evaluate site performance and recommend site-specific actions; communicate serious issues to the project team and develop action plans.
Verify that informed consent has been properly obtained and documented, maintaining patient confidentiality and assessing factors that affect safety and data integrity.
Conduct source document reviews and ensure the accuracy and completeness of clinical data in case report forms (CRFs).
Utilize query resolution techniques and support site staff in achieving timely resolutions.
Verify compliance with electronic data capture requirements and perform investigational product (IP) inventory and reconciliation.
Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF), ensuring compliance with archiving requirements.
Document activities, support patient recruitment and retention strategies, and track observations and action items in required systems.
Understand project scope, budgets, and timelines, managing site-level activities to meet project objectives.
Act as a primary liaison with study site personnel and ensure training and compliance for all assigned sites.
Participate in investigator meetings and global clinical monitoring meetings, providing audit readiness guidance.
Maintain a working knowledge of ICH/GCP guidelines and complete required training.

For Real World Late Phase Studies:

Serve as a Site Management Associate II, supporting sites throughout the study lifecycle, from identification to close-out.
Conduct chart abstraction activities and collaborate with Sponsor affiliates and local staff.
Identify and communicate out-of-scope activities to Lead CRA/Project Manager and suggest potential sites based on local knowledge.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent experience.
Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
Proficient computer skills and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Willingness to travel up to 75% regularly.

Get to Know Us: In the past five years, we’ve collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites with more than 675,000 trial patients.

Additional Information: This job description is not exhaustive, and tasks may be assigned at the company's discretion. Equivalent experience will be considered. This posting complies with applicable laws and regulations, including the Americans with Disabilities Act, providing reasonable accommodations as needed.

Join Us: If you’re ready to take on this exciting CRA II role and make a meaningful impact in clinical research, we want to hear from you!

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Cra Ii - Scra Ii (Perth/ Adelaide)

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