Sr Cra I

2+ years

Not Disclosed

Remote, USA

10 Nov. 8, 2024

Job Description

Job Type: Full Time 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

Job Title: Senior Clinical Research Associate - Sponsor Dedicated

Experience: Immunology & Rare Disease Experience Required
Company: Syneos Health
Location: Flexible / Remote
Travel: Up to 75%

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market challenges.

Our clinical development model brings both the customer and the patient to the center of everything we do. We continuously streamline and simplify our work to ensure that Syneos Health is not only easier to collaborate with but also an incredible place to work.

With 29,000 employees across 110 countries, we aim to help customers achieve their goals and deliver therapies that change lives.

Why Join Syneos Health?

At Syneos Health, we’re passionate about career development and progression for our employees. We offer a supportive and engaging environment, technical and therapeutic area training, peer recognition, and a total rewards program.

We embrace our Total Self culture, where you can bring your authentic self to work. Our diversity of thoughts, backgrounds, cultures, and perspectives allows us to create an inclusive environment where everyone feels they belong.

Job Overview

As a Senior Clinical Research Associate (Sr. CRA) with Immunology and Rare Disease expertise, you will be responsible for overseeing the full lifecycle of clinical trials, from site identification and initiation through to study closeout. You will ensure compliance with regulatory requirements, ICH-GCP, and company SOPs. This role requires a proactive, solution-oriented professional who can manage clinical operations at multiple sites, maintaining the highest standards of quality, ethics, and patient safety.

Key Responsibilities

Site Management & Monitoring:
Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely) while ensuring compliance with regulatory and study protocols.
Evaluate site performance and provide actionable recommendations to enhance site efficiency.
Informed Consent & Patient Safety:
Ensure informed consent is appropriately documented and obtained for all patients. Monitor and ensure patient safety throughout the trial by identifying and addressing potential risks, protocol deviations, or pharmacovigilance issues.
Data Management & Compliance:
Perform source document review to verify data accuracy in case report forms (CRFs). Resolve queries, drive closure within timelines, and ensure compliance with electronic data capture requirements.
Support the investigational product (IP) inventory and reconcile data to ensure adherence to protocols.
Trial Master File (TMF) Management:
Review the Investigator Site File (ISF) for completeness and timeliness. Ensure that essential documents are archived in accordance with local guidelines and regulations.
Training & Mentorship:
Act as a mentor to junior CRAs, providing guidance on clinical monitoring and site management.
Lead and participate in training sessions for internal teams and site personnel.
Collaboration & Communication:
Work closely with Sponsors, affiliates, and local country staff to ensure that all aspects of the clinical trial run smoothly.
Communicate regularly with the Lead CRA and Project Manager to ensure project objectives and timelines are met.
Audit Preparation & Regulatory Compliance:
Support site audit preparation and ensure compliance with Good Clinical Practice (GCP) and other regulatory requirements. Provide assistance with audit follow-up actions as needed.
Real World Late Phase (RWLP):
For RWLP studies, participate in chart abstraction activities, data collection, and collaborate with local teams to ensure regulatory updates are shared.
Proactively suggest new sites based on knowledge of treatment patterns, patient advocacy, and healthcare provider (HCP) relationships.

What We’re Looking For

Education: Bachelor’s degree or RN in a related field (or equivalent combination of education, training, and experience).
Experience:
- Minimum 3+ years of experience as a Clinical Research Associate, with a focus on Immunology and Rare Diseases.
- Comprehensive knowledge of GCP/ICH guidelines and local regulatory requirements.
- Proven track record in site management, patient recruitment, and study monitoring.
Skills:
- Strong organizational and time-management skills, with the ability to manage multiple sites and projects simultaneously.
- Proficient in clinical trial management systems, electronic data capture, and other relevant tools.
- Excellent communication, presentation, and interpersonal skills.
Travel: Must be able to travel up to 75% of the time, as required by the role.

What We Offer

Career Development: Continuous learning and progression opportunities.
Work-Life Balance: Flexible work environment with up to 75% travel required.
Comprehensive Benefits: Health, wellness, and retirement benefits.
Global Impact: Work with a global team making a meaningful impact on healthcare.

Get to Know Syneos Health

Over the past 5 years, Syneos Health has worked on 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites, touching the lives of 675,000+ trial patients. Whether you’re in a clinical operations or therapeutic development role, WORK HERE MATTERS EVERYWHERE.