Cra Ii / Sr Cra - Sponsor Dedicated - Rare Disease (Home-Based, Northeast Of Us)

Syneos Health

2+ years

Not Disclosed

Remote

10 Dec. 30, 2024

Job Description

Job Type: Full Time 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

CRA II / Sr CRA - Sponsor Dedicated - Rare Disease (Home-based, Northeast of US)
Updated: December 12, 2024
Location: United States-North America - USA-Pennsylvania-Home-Based, United States
Job ID: 24006594-PA975

Job Description

Senior Clinical Research Associate I

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

Our Clinical Development model places the customer and the patient at the center of everything we do. We're always looking to simplify our processes to make Syneos Health easier to work with and for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem-solvers to help our customers achieve their goals. We're agile and driven to accelerate the delivery of therapies because we're passionate about changing lives.

Why Syneos Health

Career Growth: We are committed to helping our people develop through career progression, training, and peer recognition.
Inclusive Culture: Our Total Self culture values diversity and encourages you to be your authentic self.
Global Impact: Syneos Health has worked with 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies worldwide.

Job Responsibilities

As a Senior Clinical Research Associate I, you will manage clinical monitoring and site management activities throughout the study lifecycle. Key responsibilities include:

Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with regulatory, ICH-GCP, and protocol standards.
Data Review & Documentation: Perform Source Document Reviews, verify data accuracy in case report forms (CRFs), and resolve queries in collaboration with site staff.
Clinical Operations: Ensure investigational products are dispensed and administered according to protocol and maintain site compliance with data capture and IP storage requirements.
Site Support: Manage site-level activities, resolve issues, and ensure the site is trained on clinical monitoring protocols and regulatory requirements.
Project Coordination: Support subject recruitment, retention, and awareness strategies. Track project observations and action items to resolution.
Audit Readiness: Support site preparation for audits and assist in maintaining audit readiness.
Training and Mentorship: Provide guidance and mentorship to junior CRAs and lead training sessions when needed.
Real World Late Phase (RWLP) Studies: Participate in activities such as chart abstraction and data collection and collaborate with local teams and medical science liaisons.

Additional duties include participating in bid defense meetings, suggesting operational efficiencies, and developing informed consent forms.

Qualifications

What we’re looking for:

Education & Experience: Bachelor’s degree or RN in a related field, or an equivalent combination of education and experience.
Clinical Knowledge: Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Skills: Excellent communication, interpersonal, and critical thinking skills. Proficiency in computer systems and technologies is essential.
Travel Requirements: Ability to manage up to 75% travel regularly.

Compensation & Benefits

Syneos Health offers a competitive salary and benefits package, including a company car or car allowance, medical, dental, and vision coverage, 401(k) match, employee stock purchase plan, performance-based commissions/bonus, flexible PTO, and sick time.

The base salary range for this position is $63,090 to $145,000, depending on qualifications, experience, and skill set.

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Cra Ii / Sr Cra - Sponsor Dedicated - Rare Disease (Home-Based, Northeast Of Us)

Job Description

Job Description

Why Syneos Health

Job Responsibilities

Qualifications

Compensation & Benefits

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