Job Description

Job Description

Job Description

Yoh is hiring for a Clinical Research Associate who will be a vital role in the Clinical Operations Team. The CRA will be responsible for monitoring studies, reviewing data, engaging with cites and ensuring the success of clinical trial operations and management. Candidates with recent Ophthalmology experience are encouraged to apply. 

Pay Rate - $110-140K
Location - San Jose, CA/ Remote 

Responsibilities

1. 1. Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out
   2. Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
   3. Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
   4. Monitoring and documenting investigational product dispensing, inventory, and reconciliation
   5. Monitoring and documenting laboratory sample storage and shipment
   6. Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
   7. Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
   8. Reviewing data queries and listings, and working with the study centers to resolve data discrepancies
   9. Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues
   10. Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present
   11. Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
   12. Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs

OTHER QUALIFICATIONS

1. 1. Detail oriented
   2. Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
   3. Flexibility with changing priorities
   4. Ability to efficiently perform and prioritize multiple tasks
   5. Familiarity with medical and pharmaceutical industry, and related terminology and practices
   6. Extensive knowledge of FDA regulations and their practical implementation
   7. Ability to travel, including by air or by car on short notice
   8. A valid driver's license with access to a car with up-to-date car insurance
   9. Computer proficiency in Microsoft Word, Excel, and PowerPoint

EDUCATION/ EXPERIENCE

1. 1. Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
   2. 2 years of prior experience as a Clinical Research Associate preferred

 

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit -with-disabilities  to contact us if you are an individual with a disability and require accommodation in the application process. Company Description

Founded in 1940, Yoh operates from 75 locations throughout North America and is headquartered in Philadelphia, PA. Yoh was the nation’s first technology staffing firm. As a business unit of Day & Zimmermann, Yoh has a flourishing global footprint, as our parent company operates from more than 150 worldwide locations.
Company Website:

Company Description

Founded in 1940, Yoh operates from 75 locations throughout North America and is headquartered in Philadelphia, PA. Yoh was the nation’s first technology staffing firm. As a business unit of Day & Zimmermann, Yoh has a flourishing global footprint, as our parent company operates from more than 150 worldwide locations.\r\nCompany Website:

Job Tags

Interim role, Remote job, Worldwide,

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