Clinical Trial Associate-2

5 days ago

San Diego, United States QuidelOrtho Full time

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

This position is onsite in San Diego, CA.

The Responsibilities
- Assists with data entry as necessary, and audits field clinical trial data for inclusion in regulatory submissions. Help implement and maintain clinical trial tracking databases for each clinical study. Responsible for maintaining Trial Master Files for all clinical studies.
- Works closely with the clinical team to provide clinical support.
- Assists in the conduct of readability studies to validate ease-of-use of test materials and reliability of draft procedures.
- Assembles and ships IUO kits and supplies for clinical studies. May helps clinical team identify clinical trial sites. Assists in the preparation for initiation of clinical studies and monitors and tracks the progress of those studies via in-house oversight.
- Supports obtaining IRB study approvals through direct communication with clinical sites enabling acquisition of required regulatory submission documents.
- Perform other work-related duties as assigned.

The Individual

Required:

- Requires a BS/BA in any biological science or Medical Technologist degree (or equivalent combination education and/or work experience) with a mínimal of 1-2 years progressive clinical research experience.
- Previous research or scientific technical experience in the IVD, medical device or bio/pharma industry preferred.
- Prior experience or certification in clinical trial design, Clinical Research Coordinator (i.e. CCRC), and/or data management experience highly desirable. Required experience with TMF/clinical study file documentation oversight and Quality Control, Good Clinical Practice, Good Documentation Practice, and strong understanding of the impact of the TMF on Trial Management.
- Knowledge of medical terminology and good clinical practice required.
- Detail-oriented with a high level of organizational skills; good written and verbal communication skills; excellent interpersonal skills, maintains professionalism at all times, with ability to resolve conflict.
- Advanced computer skills (Word, Excel, Outlook, Access) or equivalent required.

The Key Working Relationships

Internal Partners:

- Clinical team and regulatory staff to help implement, oversee and closeout clinical studies. Assists with in-house monitoring and auditing of clinical data during clinical field investigations in order to achieve 100% accuracy of clinical database. Works with Clinical team to assist in shipping and oversight of material supplies of clinical and beta-site field trials.

External Partners:

- Interacts via telephone and written communications with physicians, nurses, physician assistants and study site personnel at clinical trial sites. Assist with in-house specimen procurement with mínimal supervision.

The Work Environment

The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

Salary Transparency

Equal Opportunity


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