Sr Cra I

5+ years

Not Disclosed

Remote

10 Aug. 23, 2024

Job Description

Job Type: Full Time Remote 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: Senior Clinical Research Associate I

Company Overview:

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating client success. By translating unique clinical, medical affairs, and commercial insights into actionable outcomes, we address the evolving needs of the market. Our Clinical Development model centers on the customer and the patient, continually seeking to simplify and streamline 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, driven by a passion to accelerate the delivery of transformative therapies. Join us and be part of a global team that values diverse perspectives and strives to make a meaningful impact.

Why Syneos Health?

We are committed to developing our people through career progression, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture celebrates individuality and inclusivity, creating a work environment where everyone feels valued. We are dedicated to building a workplace where diversity of thought, background, and perspective is celebrated.

Job Responsibilities:

Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely) to ensure adherence to regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols. Use judgment and experience to evaluate site performance and staff, provide recommendations, and develop action plans for serious issues. Maintain up-to-date knowledge of relevant guidelines, regulations, and company SOPs.
Informed Consent and Data Integrity: Ensure informed consent procedures are properly performed and documented. Safeguard participant confidentiality and evaluate factors affecting safety and data integrity, including protocol deviations and pharmacovigilance issues.
Clinical Data Review: Review site source documents and medical records, verify accuracy and completeness of clinical data in case report forms (CRFs), and apply query resolution techniques. Utilize available technology to support data review and capture, ensuring compliance with electronic data capture requirements.
Investigational Product (IP) Management: Oversee IP inventory and reconciliation, ensure proper storage and security, and verify dispensing and administration according to protocol. Address issues related to blinded or randomized information and ensure IP is appropriately labeled, imported, and returned.
Site File Management: 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 track observations and action items. Adapt to changing project priorities and ensure timely achievement of goals.
Training and Mentorship: Act as a primary liaison with site personnel or collaborate with Central Monitoring Associates. Ensure all sites and project-specific team members are trained and compliant. Prepare for and attend investigator and sponsor meetings, and provide training or mentorship to junior CRAs.
Audit Readiness: Provide guidance on audit readiness standards and support preparation for audits and follow-up actions.
Real World Late Phase (RWLP) Responsibilities: As Sr. Site Management Associate I, support sites throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsors and affiliates, and identify potential sites based on local knowledge. Develop informed consent forms, work with the RWLP Regulatory team, and participate in bid defense meetings.

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. Basic critical thinking skills are expected.

Get to Know Syneos Health:

In the past five years, Syneos Health has been involved with 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 how you can contribute to Syneos Health and make an impact on the future of biopharmaceutical solutions.