Freelance Srcra Role

4+ years

Not Disclosed

Remote

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 / Senior Clinical Research Associate

Company Overview:

Syneos Health® is a premier, fully integrated biopharmaceutical solutions organization dedicated to accelerating client success. We turn innovative clinical, medical affairs, and commercial insights into effective outcomes, addressing the modern realities of the market. Our Clinical Development model places the customer and the patient at the core of our efforts, and we are continually striving to simplify and enhance our work processes to improve the experience for both our clients and employees.

Join us in a Functional Service Provider or Full-Service environment, where you'll work alongside a dynamic team of problem-solvers, committed to transforming the delivery of therapies. Our agile approach and dedication to making a difference mean that here, WORK MATTERS EVERYWHERE.

Why Syneos Health?

We are dedicated to the growth and development of our people, offering opportunities for career progression, supportive management, technical and therapeutic training, and a comprehensive rewards program. Our commitment to a Total Self culture ensures that every employee can be their authentic self, contributing to a global community where everyone feels valued and included.

Job Responsibilities:

Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely) to ensure compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols. Use your judgment to assess site performance, recommend actions, and address serious issues promptly. Stay current with ICH/GCP Guidelines and other relevant regulations and company procedures.
Informed Consent and Data Integrity: Confirm that informed consent processes are properly executed and documented. Ensure the confidentiality of participants and assess factors affecting their safety and the integrity of clinical data, including protocol deviations and pharmacovigilance issues.
Clinical Data Review: Review site source documents and medical records, ensure the accuracy and completeness of clinical data in case report forms (CRFs), and resolve queries both remotely and on-site. Utilize technology effectively to support data review and capture, and ensure compliance with electronic data capture requirements.
Investigational Product (IP) Management: Oversee IP inventory and reconciliation, ensure proper storage and security, and verify dispensation and administration according to protocol. Address issues related to blinded or randomized information and ensure IP is correctly labeled, imported, and managed.
Site File Management: Regularly review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF), ensuring accurate, timely, and complete documentation. Ensure compliance with archiving requirements.
Documentation and Communication: Document activities including confirmation letters, follow-up letters, and trip reports. Support recruitment, retention, and awareness strategies, and manage data tracking and resolution of action items. Adapt to changing project priorities and ensure project goals are met.
Training and Mentorship: Act as a liaison with site personnel or work with Central Monitoring Associates. Ensure site and project team members are trained and compliant. Prepare for and participate in Investigator and sponsor meetings, and provide training or mentorship to junior CRAs.
Audit Readiness: Guide site and project teams in meeting audit readiness standards and support audit preparation and follow-up.
Real World Late Phase (RWLP) Responsibilities: As Sr. Site Management Associate II, support sites from identification through close-out, understand local requirements for RWLP study designs, conduct chart abstraction, and collaborate with sponsors and affiliates. Suggest potential sites based on local knowledge and develop informed consent forms. Work with the RWLP Regulatory team and participate in bid defense meetings.

Qualifications:

Experience: Oncology therapeutic area experience preferred. Ability to travel within the UK and Ireland without restrictions.
Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Skills: Proficiency in Good Clinical Practice/ICH Guidelines and other applicable regulations. Strong computer skills, excellent communication, presentation, and interpersonal skills. Ability to manage up to 75% travel.

Get to Know Syneos Health:

In the past five years, Syneos Health has 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:

The duties and responsibilities outlined are not exhaustive. Syneos Health may assign additional tasks as needed and considers equivalent experience or education when determining qualifications. The company complies with all relevant laws, including the Americans with Disabilities Act, and provides reasonable accommodations as needed.

Explore how you can contribute to Syneos Health and make a significant impact on the future of biopharmaceutical solutions.

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