Cra Ii - Sponsor Dedicated (Home-Based, East Cost Of Us)

0-5 years

$63,090 - $126,100

12 May 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Responsibilities

Site Management:
- Perform site qualification, initiation, interim monitoring, management activities, and close-out visits (on-site or remote) ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards.
- Evaluate site and staff performance, communicate serious issues, and develop action plans.
Patient and Data Protection:
- Verify informed consent processes and ensure confidentiality of subjects.
- Assess factors affecting patient safety and data integrity.
Clinical Monitoring:
- Follow Clinical Monitoring/Site Management Plan (CMP/SMP).
- Conduct Source Document Review, verify clinical data accuracy, and resolve queries.
- Ensure compliance with electronic data capture requirements.
Investigational Product (IP) Management:
- Inventory, reconcile, and review storage and security of IP.
- Verify IP dispensing and administration per protocol.
- Ensure IP compliance with GCP, local regulations, and organizational procedures.
Documentation and Reporting:
- Maintain and review the Investigator Site File (ISF) and Trial Master File (TMF) for accuracy.
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other project documents.
- Support subject recruitment and retention strategies.
Project Management:
- Understand project scope, budgets, and timelines.
- Manage site-level activities to ensure project objectives and timelines are met.
- Adapt to changing priorities to achieve goals.
Collaboration and Training:
- Act as primary liaison with study site personnel or collaborate with Central Monitoring Associate.
- Ensure site and project-specific team members are trained and compliant.
- Participate in Investigator Meetings, sponsor meetings, and clinical training sessions.
Audit and Compliance:
- Provide guidance towards audit readiness and support audit preparation and follow-up actions.
- Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Additional Responsibilities for Real World Late Phase:
- Support sites throughout the study lifecycle.
- Conduct chart abstraction and data collection.
- Collaborate with Sponsor affiliates, medical science liaisons, and local staff.
- Train junior staff and identify potential sites based on local knowledge.

Qualifications

Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Knowledge: Good Clinical Practice/ICH Guidelines and other regulatory requirements.
Skills: Proficient in computer use and new technologies, excellent communication, presentation, and interpersonal skills.
Travel: Ability to manage up to 75% travel on a regular basis.

Compensation and Benefits

Base Salary: $63,090 - $126,100 annually, based on qualifications, skills, and experience.
Benefits: Company car or car allowance, health benefits (Medical, Dental, Vision), 401k match, Employee Stock Purchase Plan eligibility, commission/bonus eligibility, flexible PTO and sick time.

Additional Information

Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements. We also have a voluntary COVID-19 vaccination policy, with certain roles requiring proof of vaccination based on customer or local government mandates. We provide reasonable accommodations for employees or applicants with disabilities to perform essential job functions.

Interested in Applying?

If you're interested but unsure if you meet all requirements, we encourage you to apply. We consider transferrable skills from previous roles and are dedicated to building a diverse and inclusive workplace. Join our Talent Network to stay connected to additional career opportunities.

Apply now to make a meaningful impact with Syneos Health!

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