Clinical Research Project Coordinator II

at  University of WisconsinMadison

JOB SUMMARY:

The Department of OB/GYN seeks a Clinical Research Project Coordinator II who will work on basic, translational and clinical trial related research in the Department of OBGYN and as it relates to collaborators from other Departments or study sites.
We see the value in a dedicated research project coordinator who focuses on the understanding and managing the full spectrum of work as it relates to specific research initiative/global projects from patient recruitment, coordination of consent, communication with healthcare team on participant enrollment, tissue collection and processing.
The first main project will work with the Tissue Bank and/or projects that use Human tissue collections. This person will work with team to improve operations of tissue banking and work as liaison between Human Subjects Core and Tissue Collection and Processing Cores.
Additionally, this candidate will also be able to train/teach others on the research team who more specifically perform these task types on a more focused level. The ideal candidate will have excellent communication skills and effectively communicate with study PI’s on setting up and planning for new projects, database set-up, and successful recruitment and tissue collection. Candidate will also ensures data is entered accurately by study team(s), which may include monitoring study records for completeness and accuracy.
This person will identify opportunities for research infrastructure improvement in processes and then follow-up with streamlining and development of Standard Operating Procedures (SOPs).

EDUCATION:

Preferred
Bachelor’s Degree
Degree in biology or closely related field.

QUALIFICATIONS:

Required Qualifications:

• Experience in translational and clinical research studies.

Preferred Qualifications:

• Experience in women’s health.
• Experience in reproductive health.

Serves as project coordinator of multi-site clinical trial activities (activation, maintenance, and closure processes). Serves as a liaison among the Principal Investigator/research team, participating sites, study sponsors, and other collaborators to administer protocols, ensuring goals and objectives are met according to set timelines. May support, guide, train, and lead team members in the implementation of study related activities. May manage external sites participating in trials.

• 5% Serves as point of contact for external institutions participating in clinical research studies. Ensures data is entered accurately by study team(s), which may include monitoring study records for completeness and accuracy
• 30% Collaborates with investigators, research staff, study sponsors, participating sites, and other collaborators to rapidly move clinical trial research protocols through the activation process
• 30% Interfaces with investigators, research staff, sponsors, participating sites, and collaborators to maintain clinical trials, including reviewing, evaluating and implementing protocol amendments, ensuring timelines and milestones are met, and performs proper study close-out procedures. Performs effective, clear, and timely communication to ensure proper trial management
• 5% Coordinates and conducts participating site visits
• 5% May serve as a site manager
• 5% Schedules , coordinates, and prepares for sponsor site visits, ensuring that all study records are available, complete, and accurate for sponsor review
• 10% Backup lab support for Tissue collections
• 10% Backup patient coordinator for Tissue Bank and/or projects that use Human tissue collections