Clinical Trials Associate - Bilingual in Spanish and English

The Hennepin Healthcare Research Institute (HHRI) has a new opportunity for a bilingual Clinical Trials Associate (CTA) to support the COVID-19 research being conducted by Dr. Jason Baker at Hennepin Healthcare. This is primarily a remote position though an onsite presence in downtown Minneapolis, MN will be required.

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

This CTA position will work within the Hennepin International Coordinating Center (HENN-ICC), which is part of the NIH-funded STRIVE (Strategies and Treatments for Respiratory Infections and Viral Emergencies) network. STRIVE is a global clinical research consortium aimed at improving the clinical outcomes of patients with infections while being prepared to respond to infectious disease emergencies, through the rapid implementation of clinical trials designed to inform practice guidelines, public health policy, and the delivery of health care. The STRIVE network focuses on designing, implementing, and delivering the highest quality clinical research, from observational studies through randomized trials implemented globally. The HENN-ICC is one of nine international coordinating centers globally within the STRIVE network, and our team specifically oversees the conduct of study protocols at over 20 clinical sites within the U.S. and 4 clinical sites within Mexico.

POSITION SUMMARY:

The Clinical Trial Associate is responsible for assisting the Project Manager, Clinical Research 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:

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    • Assists Project Manager (PM) Clinical Research Manager (CRM), 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.
    • Works with various international and national vendors/partners, including supporting international clinical sites with local regulatory and ethics submissions and approvals.
    • Assists PMCRM/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 PMCRM/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 PMCRM/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 PMCRM/PI in the proper filing, maintenance and archival of study documents according to ICH GCP guidance and internal standard operating procedures.
    • Conducts monitoring visits with clinical sites to confirm data integrity and completeness, and submitting monitoring reports to the statistical and data monitoring center
    • 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/CRM/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 at least two to three (2-3) years' experience in a clinical research field. Experience with clinical trials preferred (e.g., at an enrolling site, coordinating center, regulatory capacity and/or monitor role)

Skill, Knowledge & Ability (SKA):

Spanish language fluency (speaking and writing) is 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 and Adobe. 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. Some domestic and international travel required.

AA/EOE of Minorities, Women, Disabilities, Veterans