Clinical Trials Associate

1 month ago

Minneapolis, Minnesota, United States Hennepin Healthcare Research Institute Full time

The Hennepin Healthcare Research Institute (HHRI) has a new opportunity for a Clinical Trials Associate to support the COVID-19 research being conducted by Dr. Jason Baker at Hennepin Healthcare.

Bilingual in English and Spanish required. Black, Indigenous, and People of Color are encouraged to apply.

This is primarily a remote position though an onsite presence in downtown Minneapolis, MN will be required.

POSITION SUMMARY:

The Clinical Trial Associate is responsible for assisting the Program Manager and other research staff by performing operational tasks associated with the conduct and coordination of clinical trials. The position will provide support to the trial coordinating center by training, supporting and monitoring conduct of clinical trials at clinical sites within the network. They will support the day-to-day tasks at the site including planning and execution of clinical trials.

ESSENTIAL JOB FUNCTIONS:

    • Assists Program Manager (PM) and Principal Investigator (PI) in collecting trial status information from collaborators (and their research staff) at clinical sites primarily in Mexico but also some US sites, synthesizing and reporting trial progress information.
    • Serves as a partner to another CTA in sharing primary responsibility for support of Mexico study sites. Some domestic and international travel required.
    • Works with various international and national vendors/ partners, including supporting international clinical sites with local regulatory and ethics submissions and approvals.
    • Assists PM/PI in preparing, finalizing and reproducing informational documents for assigned clinical trials e.g. operational manuals, newsletters, team-meeting minutes, Q&A documents, etc.
    • Assists PM/PI with written communication (e.g. form design, instruction for job function, draft cover letters)
    • Interfaces with the statistical and data monitoring center as well as clinical site staff to review and follow up on outstanding queries.
    • Tracks collection of key protocol-specific parameters (e.g. pharmacokinetic specimens, imaging studies) Assists PM/PI to prepare for training meetings & Investigator meetings. Conduct select training with clinical site staff.
    • Prepares regulatory documentation, visit report review, and contact information for various spreadsheets and/or trial management databases.
    • Receipt, review (for completeness and internal data consistency) and tracking of data received from clinical sites.
    • Assists the PM/PI in the proper filing, maintenance and archival of study documents according to ICH GCP guidance and internal standard operating procedures.
    • Support Investigation Product (IP) procurement at the sites as needed.
    • Coordinates generation and allocation of necessary administrative trial supplies among participating sites.
    • May assist PM/PI with regards to study related finances (e.g. investigator payments, purchase orders, payment request forms).

EMPLOYMENT STANDARDS:

Education/Experience:

Any equivalent combination of education and experience that provides the required knowledge and skills is qualifying. Typical qualifications would be a baccalaureate degree and three (3) years of experience with the specified research field.

Skill, Knowledge & Ability (SKA):

Spanish speaking required along with the ability to demonstrate competency via an assessment for proficiency. Requires interaction with a diverse population. Must demonstrate effective interpersonal and communication skills (verbal & written) and have proven organizational and documentation skills. Self-motivated and detail-oriented, ability to handle multiple tasks.. Adept with computer systems particularly MS Word, PowerPoint & Excel. Previous REDCap use, and experience maintaining data integrity, and knowledge of medical terminology is favorable. Knowledge of the clinical trial process is required. Should display a high standard of attendance, punctuality, confidentiality, and time management.

AA/EOE of Minorities, Women, Disabilities, Veterans

AA/EOE of Minorities/Females/Vets/Disability

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