Sr Cra I (Sponsor Dedicated) Denmark

2+ years

Not Disclosed

Remote, USA

10 Nov. 5, 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

Senior Clinical Research Associate I

Company: Syneos Health®
Location: [Location specifics not mentioned]
Job Type: Full-Time

About Syneos Health:

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We leverage clinical, medical affairs, and commercial insights to address the evolving challenges of the healthcare market. At Syneos, we place both the customer and the patient at the center of everything we do.

Our Clinical Development model is built around continuous innovation and efficiency, making 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-solving colleagues to deliver therapeutic solutions and positively impact lives.

Why Syneos Health?

At Syneos Health, we are deeply committed to career development and progression. Our supportive management and training initiatives help you develop both technical and therapeutic expertise. Our Total Self culture emphasizes authenticity and inclusivity, allowing employees to bring their true selves to work, while encouraging diversity of thought, background, and experience.

As part of a global team, you'll contribute to shaping the company we all want to work for and that our customers want to partner with. We value the diversity of perspectives and aim to create a workplace where everyone feels like they belong.

Job Responsibilities:

As a Senior Clinical Research Associate I (Sr. CRA I), you will be responsible for managing clinical sites through the study lifecycle, ensuring protocol adherence and compliance, and supporting key project objectives. Your main responsibilities include:

Site Monitoring & Management:
Conduct site qualification, initiation, monitoring, and close-out visits (both on-site and remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol guidelines. Use your judgment to assess site performance and communicate/escalate issues as needed.
Informed Consent & Patient Safety:
Ensure proper informed consent is obtained, documented, and compliant with regulatory requirements. Prioritize subject/patient safety, monitor for protocol violations, deviations, and pharmacovigilance issues.
Clinical Data Management:
Review source documents and verify that clinical data entered in the Case Report Forms (CRFs) is accurate. Apply query resolution techniques to drive timely closure of any issues identified, ensuring data integrity throughout the study.
Investigational Product (IP) Management:
Verify the safe handling, storage, and reconciliation of IP, ensuring adherence to protocol guidelines, GCP, and local regulations. Address any risks associated with blinded or randomized data.
Document & File Management:
Regularly review and reconcile the Investigator Site Files (ISF) and Trial Master Files (TMF) for accuracy and compliance. Ensure that required documents are archived according to local regulations.
Project & Budget Management:
Assist in managing project timelines, budgets, and site-level activities to meet objectives. Maintain proactive communication with site personnel to ensure project deliverables are met on time.
Training & Mentorship:
Act as a mentor for junior CRAs, providing training and guidance to support their professional development. You may also perform training and sign-off visits for new CRA staff.
Audit Preparation & Compliance:
Ensure site readiness for audits and provide audit support, ensuring that all corrective actions are taken in a timely manner.
Real World Late Phase (RWLP):
As part of late-phase study teams, you will engage in activities such as chart abstraction, data collection, and collaboration with sponsor teams, affiliates, and medical science liaisons to ensure study success.
Collaboration & Relationship Building:
Build strong relationships with local sponsors, investigators, and affiliates to ensure smooth study execution. Proactively identify and communicate out-of-scope activities to the Lead CRA/Project Manager.
Travel:
Up to 75% travel to support site visits, investigator meetings, and other project-related activities.

Qualifications:

We are looking for candidates who possess the following qualifications:

Education:
A Bachelor’s degree or RN in a related field, or equivalent experience, training, and education.
Experience:
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory standards. Prior clinical research experience is preferred, with a basic understanding of clinical trial operations.
Skills:
- Strong computer and data management skills with the ability to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage multiple priorities and adapt to changing project needs.
Travel Requirements:
Ability to manage up to 75% travel for site visits, meetings, and other project-related activities.

Why Choose Syneos Health?

Syneos Health is dedicated to helping shape the future of clinical research. Over the past five years, we have partnered with over 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. We’ve conducted over 200 studies across 73,000 sites, impacting the lives of 675,000+ trial participants.

No matter your role, at Syneos Health, you’ll be part of a forward-thinking team dedicated to creating positive change and driving results.

Additional Information:

The responsibilities described in this job description are not exhaustive and may be subject to change at the discretion of the company. Syneos Health is an equal opportunity employer committed to complying with all applicable legislation, including accommodations for individuals with disabilities. We encourage diverse applicants and provide reasonable accommodations as necessary to support employees' essential functions.

Ready to Make a Difference?
Apply now to join Syneos Health and help us change lives through innovative clinical research!