Sr Cra I

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: Senior Clinical Research Associate I

Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We convert unique clinical, medical, and commercial insights into actionable outcomes that address the complexities of today’s market.

Our Clinical Development model places both the customer and the patient at the forefront of our operations. We continually seek ways to simplify and enhance our processes, making Syneos Health not only easier to work with but also a rewarding place to work.

As part of our team—whether in a Functional Service Provider partnership or a Full-Service environment—you'll collaborate with passionate problem solvers to help our clients achieve their goals. Our agility and commitment to delivering therapies reflect our deep-rooted passion for changing lives.

Why Syneos Health?
We prioritize the development of our employees through career advancement opportunities, supportive management, technical training, peer recognition, and comprehensive rewards programs. Our "Total Self" culture allows you to bring your authentic self to work, fostering a diverse and inclusive environment where everyone feels valued.

Key Responsibilities:

Conduct site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely) while ensuring compliance with regulatory standards, ICH-GCP, and study protocols. Utilize your experience to assess site performance, escalate serious issues, and formulate action plans.
Ensure the informed consent process is conducted thoroughly and documented for each subject, maintaining confidentiality and assessing factors that could impact patient safety and data integrity.
Implement the Clinical Monitoring/Site Management Plan (CMP/SMP) by:
- Evaluating site processes and conducting Source Document Reviews.
- Verifying the accuracy and completeness of data in case report forms (CRFs).
- Resolving queries effectively and guiding site staff as necessary.
- Utilizing technology to support clinical study 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 issues related to blinded or randomized information, applying knowledge of GCP and local regulations to ensure proper handling of IP.
Review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF), and ensuring compliance with local document archiving requirements.
Document activities through confirmation letters, trip reports, and other project-related documentation, supporting patient recruitment and retention efforts.
Understand project scope, budgets, and timelines, managing site-level activities to achieve project objectives efficiently. Adapt quickly to changing priorities to meet targets.
Serve as the primary liaison with project site personnel, ensuring compliance and training for all site team members.
Prepare for and participate in Investigator Meetings and global project staff meetings, and attend clinical training sessions.
Provide guidance on audit readiness and assist with audit preparations and follow-up actions.

Additional Responsibilities for Real World Late Phase (RWLP):

Support sites throughout the study lifecycle from identification to close-out.
Have a thorough understanding of local requirements for real-world late-phase study designs.
Engage in chart abstraction activities and data collection.
Build relationships with Sponsors, medical science liaisons, and local staff as needed.
Communicate out-of-scope activities to the Lead CRA/Project Manager and suggest potential sites based on local knowledge of treatment patterns.
Identify operational efficiencies and process improvements, and develop country-level informed consent forms.
Collaborate with the RWLP Regulatory team to ensure updated regulatory information is shared and applied.
Participate in bid defense meetings.

Qualifications:

Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
Proficient in computer skills with a willingness to embrace new technologies.
Excellent communication, presentation, and interpersonal skills, along with basic critical thinking abilities.
Willingness to manage travel requirements of up to 75%.

Get to Know Syneos Health:
In the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, participating in over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter your role, we encourage initiative and challenge the status quo in our dynamic environment. Discover more about us at Syneos Health.

Additional Information:
This job description is not exhaustive, and responsibilities may change 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 to assist employees and applicants in performing essential job functions. If you're interested but may not meet every qualification, we encourage you to apply—your unique skills might be exactly what we need!