Clinical Trial Associate
needed for a contract opportunity with Yoh Scientific's client located in Durham, NC.
This position is for a major pharmaceutical company,
and the ideal candidate would have a BS degree in a scientific field with at least 1-2 years of experience with on-site monitoring (a must).
Shift: Monday - Friday, 8 am - 4:30 pm.
Responsibilities
- Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study.
- Has knowledge of the therapeutic area and product.
- Participates in CRF development, IVRS set-up, central lab set-up, and other vendor processes set-up, with supervision
- Assists in the management of vendor performance during conduct of the study.
- Assists in evaluation of vendor performance during conduct of the study.
- Oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance, with supervision.
- Carries out in house clinical monitoring activities
- Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up
- Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine clinical trial protocol, GCP/ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study
- Assist in the clinical trial management
- Tracks study specific tasks and progress of the trial
- Assists with effective and timely audit/inspection responses
- Performs regulatory document review and approval for IP release
- Monitors processes for distribution and tracking of SAE's, safety documentation, and pregnancies
- Collaborates with data management to resolve queries
- Facilitates investigator site payments, as applicable
- Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation
- Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). Reviews and tracks study documents, including project files both electronically and in the Trial Master File and Project Status Reports.
- Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). Prepares accurate and complete meeting minutes for various meetings.
Qualifications
- BS degree in a scientific field with at least 1-2 years of experience with on-site monitoring (a must).
Opportunity is Calling,
Apply Now!
Contract:
12-month contract with potential for extension and/or conversion.
Pay rate:
$24.60 - $36.00 per hour depending on experience, W2.
Recruiter:
Ery Baniqued
What's In It for You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!
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
https://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.