Clinical Trials Associate-QuidelOrtho

Job Description

Job Title: Clinical Trials Associate

Company: QuidelOrtho

Location: Athens, OH

Pay: $21 – 25 per hour

AI Pay Analysis: The hourly rate of $21 to $25 for a Clinical Trials Associate in Athens, OH, is generally considered competitive and aligns with industry standards for entry to mid-level positions in the field. While compensation can vary based on experience, education, and the specific duties associated with the role, most sources indicate that similar positions in Ohio typically offer hourly rates ranging from around $20 to $30, depending on factors like the employer and the complexity of the trials. Therefore, the offered rate appears to be at the lower end of the spectrum but remains within a reasonable range given the cost of living in Athens.

Job description:
The Opportunity
QuidelOrtho combines the expertise of Quidel Corporation and Ortho Clinical Diagnostics to establish a premier in vitro diagnostics company recognized for excellence in immunoassay and molecular testing, clinical chemistry, and transfusion medicine. With a workforce exceeding 6,000 and operations in over 130 countries, we deliver prompt, precise, and dependable testing solutions at every point of care— from home to hospital, and laboratory to clinic. Our corporate culture prioritizes the well-being of our team members, fostering an environment conducive to happiness, inspiration, and engagement. We are dedicated to nurturing meaningful connections, as we recognize that employee satisfaction is intrinsically linked to organizational success. Join us as we embark on our mission to harness the power of diagnostics for a healthier future for all.

The Role
As we expand at QuidelOrtho, we are looking for a Clinical Trials Associate to assist our Clinical Affairs team. This role involves supporting a wide range of clinical team activities, including study start-up, oversight, and closure. Responsibilities include coordinating the preparation and assembly of clinical trial supplies and materials for distribution to clinical sites under minimal to moderate supervision. You will also maintain tracking information related to clinical materials, shipments, and inventory. Collaboration with the Data Management team will be essential for tracking and managing Case Report Forms (CRFs) and Laboratory Submission Forms (LSFs). You will assist in maintaining files and organizing both written and electronic documentation of all study records and site interactions in the Trial Master File (TMF). Effective communication with sites regarding query resolution is vital to ensure compliance with protocols and data accuracy. Additionally, you will be involved in data entry, data auditing, clinical site queries, and overseeing data flow from multiple clinical sites in a timely and professional manner. Responsibilities will also include coordinating in-house specimen procurement studies, demonstrating a willingness and ability to learn, understand, and apply regulatory guidelines and Good Clinical Practices (GCP) relevant to IVD and Medical Devices. Familiarity with GCP, FDA regulations, and applicable Standard Operating Procedures for clinical research is essential. You will assist with the operation and maintenance of our Biorepository and all reference laboratory samples while developing your knowledge of regulatory procedures and Quidel product development processes. Interactions with study coordinators and in-house study participants are integral to this role.

This position is located onsite in Athens, OH.

The Position
– Assist with data entry as needed and audit field clinical trial data for regulatory submissions. Help implement and maintain clinical trial tracking databases for each study and ensure the integrity of Trial Master Files for all clinical studies.
– Collaborate closely with the clinical team to provide essential clinical support.
– Assist in conducting readability studies to validate the usability of test materials and the reliability of drafted procedures.
– Assemble and ship Investigational Use Only (IUO) kits and supplies for clinical studies. You may aid the clinical team in identifying potential clinical trial sites and preparing for the initiation of studies, while also monitoring their progress through in-house oversight.
– Facilitate the acquisition of Institutional Review Board (IRB) study approvals by communicating directly with clinical sites to obtain necessary regulatory submission documents.
– Recruit subjects for in-house specimen acquisition and maintain adequate supplies to support development needs.
– Perform additional work-related duties as assigned.

The Individual
Required:
– A BS/BA in a biological science or a Medical Technologist degree (or an equivalent combination of education and/or experience) is required, alongside a minimum of 1-2 years of progressive clinical research experience.
– Prior experience or certification in clinical trial design, Clinical Research Coordinator (e.g., CCRC), and/or data management is highly desirable. Experience with TMF oversight and documentation quality control, Good Clinical Practice, Good Documentation Practice, and an understanding of TMF impacts on Trial Management are required.
– Proficiency in medical terminology and adherence to good clinical practice are essential.
– A detail-oriented disposition with strong organizational, written, and verbal communication skills, coupled with excellent interpersonal abilities, is necessary. Professionalism and conflict resolution skills are paramount.
– Proficiency in advanced computer skills (Word, Excel, Outlook, Access) or equivalent is required.
– Ability to accurately log and receive incoming biological samples into a biorepository management system.
– Capability to properly store samples in designated freezers and retrieve samples upon request.
– Conduct simple database queries to locate samples.
– Note that this position is not currently eligible for visa sponsorship.

Preferred Skills:
– Familiarity with Zebra printers and/or Bartender label printing software.
– A self-starter capable of learning new software independently.
– Previous research or technical experience in the IVD, medical device, or bio/pharma industry is preferred.

The Key Stakeholders
Internal Partners:
– Collaborate with the clinical team and regulatory staff to implement, oversee, and close out clinical studies. Assist in the in-house monitoring and auditing of clinical data during field investigations to achieve a 100% accuracy rate in the clinical database. Work alongside the Clinical team to facilitate the shipping and oversight of material supplies for clinical and beta-site field trials.

External Partners:
– Interact through telephone and written communications with physicians, nurses, physician assistants, and study site personnel at clinical trial locations. Assist with in-house specimen procurement with minimal supervision.

The Work Environment
The characteristics of the work environment are representative of a manufacturing, laboratory, or warehouse setting. This includes handling viral and bacterial hazards, potentially hazardous chemicals, and infectious bodily fluids, tissues, and samples. The position requires up to 75% of time spent at a desk, as well as standing or sitting for extended periods. Flexible work hours may be necessary to meet project deadlines.

Physical Demands
This role requires the ability to lift up to 20 lbs regularly. Walking, standing, and sitting for prolonged periods (up to 75% of the day) are routine tasks. Specific vision abilities necessary for this role include close and distance vision, as well as the ability to adjust focus. Personal protective equipment is mandated as applicable, and there may be extended periods of working within freezers for Biorepository management.

Salary Transparency
The salary range for this position reflects a broad spectrum of factors, including education, experience, knowledge, skills, geographic location, and individual capabilities, aligned with internal equity and market data. It is uncommon for individuals to be hired at or near the upper end of the salary range for their role, as compensation decisions are tailored to the specifics of each case. The salary range for this position is $21.00 to $25.00 per hour. QuidelOrtho also offers a comprehensive benefits package that includes medical, dental, and vision insurance, as well as life and disability insurance, a 401(k) plan, an employee assistance program, an Employee Stock Purchase Plan, paid time off (including sick leave), and paid holidays. All benefits are non-contractual, and QuidelOrtho reserves the right to modify, terminate, or enhance benefits as deemed appropriate.

Equal Opportunity
QuidelOrtho is committed to fostering an inclusive environment and providing equal opportunity for all individuals, including those with disabilities. We ensure every candidate has the chance to apply for positions for which they qualify, regardless of race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is equally committed to providing reasonable accommodations to qualified individuals to facilitate their performance of job duties. If you need assistance or an accommodation to apply due to a disability, please contact us.

Job Posting Date: Sun, 23 Feb 2025 05:38:14 GMT

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