Clinical Research Associate Ii

3-7 years

Not Disclosed

Remote, USA

10 July 3, 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, 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

Clinical Research Associate II

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

Our Clinical Development model prioritizes both customer and patient, continuously simplifying and streamlining our processes. This not only enhances our relationships with customers but also fosters a supportive work environment.

Join us, whether in a Functional Service Provider partnership or a Full-Service environment, and collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health

We are dedicated to developing our people through career progression, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture allows you to authentically be yourself, uniting us globally. We continually strive to create an inclusive workplace where everyone feels they belong.

Job Responsibilities

Site Management: Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring compliance with regulatory, ICH-GCP, or Good Pharmacoepidemiology Practice (GPP) guidelines. Use judgment to evaluate site and staff performance, recommend actions, and communicate serious issues to the project team.
Informed Consent: Verify and document the informed consent process for each subject/patient. Protect subject/patient confidentiality and assess factors affecting safety and data integrity, such as protocol deviations and pharmacovigilance issues.
Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assess site processes.
- Conduct Source Document Review of site documents and medical records.
- Verify the accuracy and completeness of clinical data in case report forms (CRF).
- Apply query resolution techniques and provide guidance to site staff.
- Utilize hardware and software for effective data review and capture.
- Ensure site compliance with electronic data capture requirements.
Investigational Product (IP) Management: Perform IP inventory and reconciliation. Review storage and security, ensuring IP is dispensed and administered according to protocol. Verify compliance with GCP/local regulations and company procedures.
Documentation and Reporting: Routinely review the Investigator Site File (ISF) for accuracy and completeness. Reconcile ISF with the Trial Master File (TMF). Ensure proper archiving of essential documents. Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other project documents. Support subject/patient recruitment and retention strategies. Enter data into tracking systems.
Project Management: Understand project scope, budgets, and timelines. Manage site-level activities and communication to meet project objectives. Adapt quickly to changing priorities.
Liaison and Training: Act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate. Ensure all assigned sites and project-specific team members are trained and compliant. Prepare for and attend Investigator Meetings and sponsor meetings. Participate in clinical monitoring/project staff meetings and training sessions.
Audit Readiness: Provide guidance towards audit readiness standards and support preparation for audits and follow-up actions.
Real World Late Phase Responsibilities:
- Support site throughout the study lifecycle.
- Understand local requirements for late phase study designs.
- Conduct chart abstraction and data collection.
- Collaborate with Sponsor affiliates, medical science liaisons, and local staff.
- Train junior staff as needed.
- Identify and communicate out-of-scope activities to Lead CRA/Project Manager.
- Suggest potential sites based on local knowledge.

Qualifications

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

Get to Know Syneos Health

In the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites with 675,000+ trial patients. No matter your role, you’ll take initiative and challenge the status quo in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks and responsibilities listed in this job description are not exhaustive. The company may assign other tasks as necessary. Equivalent experience, skills, and education will be considered. The company is committed to compliance with the Americans with Disabilities Act and the EU Equality Directive, providing reasonable accommodations as needed.

At Syneos Health, we provide an environment where Our People can thrive, develop, and advance. Benefits include a company car or car allowance, medical, dental, and vision health benefits, 401k match, Employee Stock Purchase Plan, performance-based commissions/bonuses, flexible PTO, and sick time. The annual base salary ranges from $62,000 to $145,100, depending on qualifications and experience.

Syneos Health has a voluntary COVID-19 vaccination policy and encourages employees to be fully vaccinated. Compliance with local government or customer vaccine requirements may be necessary.

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