Sr. Clinical Research Associate, IVD/Diagnostics

Kelly Science, Engineering, Technology & Telecom; Sunnyvale (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

An innovative biotech company is seeking a Senior Clinical Research Associate to lead clinical trials and ensure compliance with regulatory standards. In this exciting role, you will be responsible for executing all activities related to clinical studies, including site selection, monitoring, and data integrity checks. The position offers the opportunity to work remotely while making a significant impact on the development of cutting-edge diagnostic solutions. If you have a passion for clinical research and a strong background in IVD products, this is the perfect opportunity to advance your career in a dynamic environment.

Qualifications

• 5-8 years of IVD monitoring experience required.
• Bachelor’s degree in Clinical Sciences or related field is essential.

Responsibilities

• Execute clinical study activities including site selection and monitoring.
• Prepare study documents and maintain compliance with GCP.

Skills

GCP knowledge

Excellent communication skills

Clinical trial management

Problem-solving skills

Education

Bachelor’s degree in a scientific discipline

Tools

Clinical trial management software

Biological databases

Job description

Kelly Science & Clinical is seeking a Sr. CRA for a fulltime, long-term contract position with a biotech company in California. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

The Sr. Clinical Research Associate is responsible for the execution of clinical trials in addition to supporting the study site identification, monitoring plan, and implementation of all aspects of assigned clinical trials. Works with and may help guide a study team regarding all operational activities for new and/or ongoing in vitro diagnostic clinical evaluations.

***Must have IVD monitoring experience clearly documented on resume or your application will be rejected.***

This position is part of the Clinical Affairs department and will be a Remote position located in the US. Our client’s vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

Execute all activities related to a clinical study, including (but not limited to):

• Clinical site selection
• Site contract and budget negotiation
• Study initiation visits
• Interim monitoring visits
• Study close out visits
• Data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness.

Identify and suggest ways to resolve problems or issues at site associated with GCP or protocol compliance which could affect the integrity of the data or timely completion of the clinical study.

Prepare study documents for review by project lead. Documents may include but are not limited to:

• Training materials
• Case Report Forms
• Study procedure guidance document
• Protocol specific ICF

Maintain a high level of familiarity with GCP and assigned protocols.

The essential requirements of the job include:

• Bachelor’s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry and/or Human Physiology, or similar).
• Minimum of 5 to 8 years of experience with monitoring In Vitro Diagnostic (IVD) products or medical devices.
• Experience in all aspects of a clinical trial including, but not limited to, clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms, etc.).
• Remain current on clinical trial regulatory requirements and guidelines (e.g. GCP, ICH, FDA, etc) with the ability to translate current regulatory requirements into clinical trial.
• Excellent oral and written communication skills. Ability to develop strong rapport with investigators and site staff.
• Ability to travel 25 – 50%
• Solo international travel will be required 4-6 times per year

It would be a plus if you also possess previous experience in:

• Experience with in vitro diagnostic (IVD) products in molecular diagnostics or immunodiagnostics especially in the areas of oncology and/or infectious disease
• Experience with laboratory automation and biological databases
• CCRA certification