Cra Ii- Sponsor Dedicated

2+ years

Not Disclosed

Remote, USA

10 Aug. 23, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 global biopharmaceutical solutions organization dedicated to accelerating customer success. We integrate clinical, medical affairs, and commercial insights to address the evolving challenges of the market. Our Clinical Development model centers around the customer and the patient, striving to simplify and streamline our processes to enhance both client and employee experiences. Whether in a Functional Service Provider partnership or a Full-Service environment, we foster innovation and collaboration to deliver therapies that transform lives.

Why Syneos Health?

At Syneos Health, we are committed to career development and progression through supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages authenticity and inclusivity, creating a work environment where everyone can thrive. Join us and contribute to a company that values diverse perspectives and fosters a sense of belonging.

Job Responsibilities:

Site Monitoring: Perform site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely), ensuring compliance with regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) guidelines, and the study protocol. Evaluate site performance, address serious issues, and develop action plans as needed. Maintain up-to-date knowledge of ICH/GCP guidelines, regulations, and company SOPs.
Informed Consent and Data Integrity: Verify that informed consent procedures are properly performed and documented. Safeguard participant confidentiality and assess site factors affecting safety and data integrity, such as protocol deviations and pharmacovigilance issues.
Clinical Data Review: Conduct source document reviews, ensure accuracy and completeness of data entered in case report forms (CRFs), and resolve queries within agreed timelines. Utilize available technologies for data review and capture, ensuring compliance with electronic data capture requirements.
Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and security. Ensure proper dispensing and administration of IP according to protocol and regulations, and manage issues related to blinded or randomized information.
Site File Management: Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF), ensuring compliance with archiving requirements and local regulations.
Documentation and Communication: Document activities, including confirmation letters, follow-up letters, and trip reports. Support recruitment and retention strategies, track observations and action items, and adapt to changing project priorities.
Liaison and Training: Act as the primary liaison with site personnel or collaborate with Central Monitoring Associates. Ensure site and project team training on requirements. Prepare for and attend investigator meetings, sponsor meetings, and clinical training sessions.
Audit Readiness: Provide guidance on audit readiness standards and support audit preparation and follow-up actions.
Additional Responsibilities for Real World Late Phase Studies: As Site Management Associate II, support sites throughout the study lifecycle, perform chart abstraction, collaborate with sponsor affiliates, and train junior staff. Suggest potential sites based on local knowledge and communicate out-of-scope activities to the Lead CRA/Project Manager.

Qualifications:

Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience: Knowledge of Good Clinical Practice/ICH Guidelines and other relevant regulations. Prior experience in clinical research or site management is preferred.
Skills: Proficiency with computer systems and technologies, excellent communication and interpersonal skills, and the ability to manage up to 75% travel.
Additional Skills: Ability to manage multiple priorities, adapt to changing environments, and work independently with minimal supervision.

Get to Know Syneos Health:

Over the past five years, Syneos Health has been involved in 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and has conducted over 200 studies across 73,000 sites with more than 675,000 trial patients.

Additional Information:

The responsibilities and duties outlined in this job description are not exhaustive. Syneos Health may assign additional tasks as needed and will consider equivalent experience or education when determining qualifications. The company is committed to compliance with all applicable laws, including the Americans with Disabilities Act, and provides reasonable accommodations to support employees and applicants.

Explore more about Syneos Health and discover how you can contribute to our mission of accelerating the delivery of life-changing therapies.

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