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.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Clinical Trials Associate to support our Clinical Affairs team. This person will be responsible for assisting 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). Communicate with sites regarding query resolution to ensure compliance with specified protocols and accuracy of submitted data. Participate in data entry, data auditing, clinical site queries and overall clinical data flow from multiple clinical sites in a timely and professional manner. Coordinate in-house specimen procurement studies. Willingness and ability to learn, understand and apply regulatory guidelines and Good Clinical Practices (GCP's) applicable to IVD and Medical Devices for conducting clinical field trials, CLIA Waiver and 510(k) submission studies. Be familiar with GCP, FDA regulations and relevant Standard Operating Procedures for clinical research. Assist in the operation and maintenance of our Biorepository and all reference laboratory samples. Develop skill and knowledge with regulatory procedures and become familiar with Quidel product development procedures. Interact with study coordinators and in-house study participants.

This position is onsite in Athens, OH.

The Position

• 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.
• 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 minimal of 1-2 years progressive clinical research experience.
• 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.
• Accurately log and receive incoming biological samples into a biorepository management system.
• Properly store samples in designated freezers and retrieving samples upon request.
• Perform simple database queries to locate samples.
• This position is not currently eligible for visa sponsorship.

Preferred Skills:

• Familiarity with Zebra printers and/or Bartender label printing software.
• Ability to learn new software independently.
• Previous research or scientific technical experience in the IVD, medical device or bio/pharma industry preferred.

The Key Stakeholders

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 minimal supervision.

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Physical Demands

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. May be working within freezers for extended periods of time for Biorepository management.

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 the facts and circumstances of each case. The salary range for this position is $21.00 to $25.00/hour. 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.

Equal Opportunity

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 recruiting@quidelortho.com.