Administrative Assistant, OBGYN Clinical Research Center - Department of Obstetrics & Gynecology

Wayne State University•Detroit, MI

19h•Onsite

About The Position

Wayne State University is searching for an experienced Administrative Assistant, OBGYN Clinical Research Center - Department of Obstetrics & Gynecology at its Detroit campus location. Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich, high-quality education. Our deep-rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities which prepare students for success in a global society. Position Purpose: Provide administrative assistance to the Clinical Research Center Manager in coordinating and managing personnel, financial, regulatory, and administrative services for a clinical research center within the research center. Support the operational goals and objectives of multiple clinical trials and research studies through the application of specialized skills in clinical research administration, regulatory compliance, and data management acquired through job-related training and on-the-job experience. This position reports to the Manager, Clinical Research Center. Essential Functions: Provide administrative support, including calendar management, meeting coordination, travel arrangements, data entry, and correspondence using clinical research software and databases. Answer questions and provide information to research staff, investigators, and sponsors. Assist the Clinical Research Center Manager in preparing, organizing, and maintaining regulatory documents for submission to Institutional Review Boards (IRBs), sponsors, and regulatory agencies using electronic regulatory systems. Participate in tracking protocol amendments, informed consent versions, continuing reviews, and other regulatory submissions. Provide support with ensuring compliance with federal regulations, institutional policies, and study-specific requirements. Coordinate and participate in the preparation and processing of paperwork for study personnel for research studies. Establish and monitor related record-keeping systems for studies, such as training records, CVs, and certifications. Interpret and apply internal operating procedures, University policies, and sponsor requirements. Assist with coordinating student interns, college work study, and technician support staff. Plan events and assign work activities; train in appropriate office methods and procedures and monitor workflow for these positions. Create and maintain study databases, spreadsheets, and tracking systems for participant enrollment, study milestones, protocol deviations, and adverse events. Generate reports for sponsors and internal monitoring Coordinate study start-up activities, including preparation of Investigator Site Files (ISFs), organization of study-specific documents and forms, and assistance with contract documentation. Maintain organized electronic and paper filing systems. Assist the Clinical Research Manager with the administration and consulting with outside facilities for multiple clinical research protocols and processes for clinical research studies. Performs other related duties as assigned.

Requirements

Associate degree from an accredited college or university.
Experienced (minimum 2 years of job-related experience)
Ability to maintain confidentiality of protected health information (PHI) and proprietary study data.
Working knowledge of Microsoft Office Suite, particularly Word and Excel (required). Knowledge of or willingness to learn clinical research regulations, including Good Clinical Practice (GCP), IRB requirements, and HIPAA compliance. Knowledge of University administrative policies and procedures preferred. Familiarity with Adobe Acrobat and electronic document management (preferred)
Proficiency in creating and maintaining databases, spreadsheets, and tracking systems. Ability to learn and use clinical research software and electronic regulatory systems (e.g., e-Reg, CTMS, EDC systems). Strong organizational skills with the ability to maintain detailed, accurate records and filing systems. Excellent written and verbal communication skills. Ability to prioritize multiple tasks and meet regulatory deadlines. Data entry and document processing skills with close attention to detail
Ability to work independently and exercise sound judgment in routine situations. Ability to establish and maintain effective working relationships with research staff, investigators, sponsors, study participants, and University personnel. Ability to manage confidential information with discretion and maintain HIPAA compliance. Ability to adapt quickly to changing priorities in a fast-paced clinical research environment. Ability to learn new software systems and procedures efficiently. Ability to follow detailed protocols and standard operating procedures (SOPs). Ability to work collaboratively as part of a research team

Nice To Haves

Bachelor's degree from an accredited college or university preferred.
Experience supporting clinical research operations preferred.
Procedural understanding of clinical trial activities and regulatory compliance preferred.
Knowledge of University administrative policies and procedures preferred.
Familiarity with Adobe Acrobat and electronic document management (preferred)

Responsibilities

Provide administrative support, including calendar management, meeting coordination, travel arrangements, data entry, and correspondence using clinical research software and databases. Answer questions and provide information to research staff, investigators, and sponsors.
Assist the Clinical Research Center Manager in preparing, organizing, and maintaining regulatory documents for submission to Institutional Review Boards (IRBs), sponsors, and regulatory agencies using electronic regulatory systems. Participate in tracking protocol amendments, informed consent versions, continuing reviews, and other regulatory submissions. Provide support with ensuring compliance with federal regulations, institutional policies, and study-specific requirements.
Coordinate and participate in the preparation and processing of paperwork for study personnel for research studies. Establish and monitor related record-keeping systems for studies, such as training records, CVs, and certifications. Interpret and apply internal operating procedures, University policies, and sponsor requirements.
Assist with coordinating student interns, college work study, and technician support staff. Plan events and assign work activities; train in appropriate office methods and procedures and monitor workflow for these positions.
Create and maintain study databases, spreadsheets, and tracking systems for participant enrollment, study milestones, protocol deviations, and adverse events. Generate reports for sponsors and internal monitoring
Coordinate study start-up activities, including preparation of Investigator Site Files (ISFs), organization of study-specific documents and forms, and assistance with contract documentation. Maintain organized electronic and paper filing systems.
Assist the Clinical Research Manager with the administration and consulting with outside facilities for multiple clinical research protocols and processes for clinical research studies.
Performs other related duties as assigned.

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