Sponsor Dedicated Cra Ii/ Sr Cra - Home Based Ita

2+ years

Not Disclosed

Remote, USA

10 Oct. 21, 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

Sponsor Dedicated CRA II/Sr CRA - Home Based ITA

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

Our Clinical Development model places both the customer and patient at the heart of everything we do. We are constantly looking for ways to simplify and streamline our work to make Syneos Health easier to collaborate with and work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team 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 passionate about developing our people through career progression, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters an environment where you can be your authentic self, uniting us globally and ensuring everyone feels they belong.

Job Responsibilities

Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, and study protocols.
Verify that the informed consent process is adequately performed and documented for each subject/patient, maintaining confidentiality.
Assess factors that may affect subject/patient safety and clinical data integrity at investigator sites, addressing protocol deviations and pharmacovigilance issues.
Execute the Clinical Monitoring/Site Management Plan (CMP/SMP) by:
- Assessing site processes.
- Conducting Source Document Reviews of appropriate site documents and medical records.
- Verifying the accuracy and completeness of data entered in case report forms (CRFs).
- Applying query resolution techniques both remotely and on-site, providing guidance to site staff as needed.
- Utilizing available technology to support clinical study data review and capture.
- Ensuring site compliance with electronic data capture requirements.
Perform investigational product (IP) inventory, reconciliation, and review storage and security, ensuring IP is dispensed and administered according to protocol.
Routinely review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF).
Document activities through confirmation letters, trip reports, and other project documents in line with SOPs and CMP/SMP.
Support subject/patient recruitment, retention, and awareness strategies, tracking site-level activities to ensure project timelines are met.
Act as a primary liaison with study site personnel, ensuring compliance with training requirements.
Prepare for and attend Investigator Meetings and sponsor face-to-face meetings, participating in global clinical monitoring/project staff meetings.
Guide audit readiness at the site and project levels, supporting audit preparations and follow-up actions.
Maintain a working knowledge of ICH/GCP Guidelines and company SOPs, completing assigned training as required.
For Real World Late Phase studies, the CRA II will use the title of Site Management Associate II, with additional responsibilities including:
- Providing support throughout the study lifecycle from site identification to close-out.
- Knowledge of local requirements for real-world late phase study designs.
- Conducting chart abstraction and data collection.
- Collaborating with Sponsor affiliates and local staff.
- Identifying and communicating out-of-scope activities to the Lead CRA/Project Manager.
- Suggesting potential sites based on local knowledge of treatment patterns and patient advocacy.

Qualifications

What We’re Looking For:

At least 2 years of experience as a certified CRA, according to M.D. 15 Nov 2011.
Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
Proficiency in computer skills and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel of up to 75% on a regular basis.

Get to Know Syneos Health

Over the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites and 675,000+ trial patients. Join us in taking initiative and challenging the status quo in a competitive and evolving environment.

Additional Information:

The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign other tasks at its discretion. Equivalent experience, skills, and education will be considered. This document does not constitute an employment contract.