Clinical Trials Associate

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.

As we continue to grow as QuidelOrtho, we are seeking a Clinical Trials Associate to assist in all clinical team activities for start-up, oversight, and study closure to include coordinating the preparation and assembly of clinical trial supplies and materials for distribution to clinical sites with minimal/moderate supervision. Maintain related tracking information of all clinical materials, shipments, and inventory. Assist the Data Management team in tracking and management of Case Report Forms (CRFs) and Laboratory Submission Forms (LSFs). Assist in maintaining files and tracking of all written and electronic documentation for all study records and site interactions in the Trial Master File (TMF). This position in onsite in Athens OH.

• 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.

• Recruits subject for in-house specimen acquisition and maintains necessary supplies for specimen acquisition in support of development needs.

• This position may require up to 25-30% travel.

• Perform other work-related duties as assigned.

Required:

• Requires a BS/BA in any biological science or Medical Technologist degree (or equivalent combination education and/or work experience).

• 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.

• 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.

Preferred:

• 1-2 years progressive clinical research experience.

• Internal partners: Works collaboratively with clinical team and regulatory staff.

• External partners: Interacts with physicians, nurses, physician assistants and study site personnel at clinical trial sites.

The work environment characteristics are a combination of both an office and laboratory 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.

This position may require up to 25-30% travel.

Salary Transparency

The salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. A salary range for this position is $35,700-$66,000. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at .

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