Job Summary

The department of Family Medicine is seeking a Research Coordinator for a series of studies focused on improving cervical cancer screening and reducing the incidence and mortality from cervical cancer. Our studies will develop, evaluate, study efficacy and implementation of new devices for self-sampling, new molecular markers for testing, working with industry to develop FDA acceptable testing devices as well as the qualitative and decision-making aspects of screening for HPV instead of the speculum directed Pap test. We will be developing study protocols that will use a new reference laboratory for WHO standards for HPV antibody titers to monitor HPV prophylactic vaccination.

This individual will assist the PI in overall project management, including Cancer Center Protocol Review Committee and IRB submissions, tech transfer agreements, and database creation and management. Responsible for working with multi-site community practices to recruit participants as needed. Duties include working with all practices to determine how to identify eligible participants, sending letters of invitation, screening eligible subjects, recruiting participants and meeting them at the University of Michigan and Community practices to administer consent, and questionnaires. Periodic duties will include the development of Standard Operating Procedures, writing quarterly Newsletters to the practices, aiding in IRB functions and the development of Business Agreements and Individual Investigator Assurance documents. Responsible for conducting the trials according to GCP, OHRP and other applicable regulations.

The individual will directly report to the physician investigator and interface with the IRB, Data coordinating center, financial experts, and other internal and external parties.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Responsibilities*

Develop and execute research study plans and day to day work plans

Ensure that study protocols and study activities meet all institutional and funder requirements

Assist in the preparation of all regulatory documents (applications, amendments, continuing reviews, ORIOs, and adverse events). Brings to the PIs attention any questions or issues occurring in the study.

Develop and implement corrective actions as needed to ensure compliance with funder regulations, including documenting deviations from protocol

Assist with progress reports and communications with external stakeholders, funders and regulatory bodies

Serve as the primary liaison with the primary care research network, work with the research network to recruit and maintain clinical sites, and maintain communications with designated representatives of research clinical sites

Coordinate data collection efforts and records management

Assist the PI in any grant- research- and academic related activities that arise

Assist the PI in grant development and submission

Supervise and mentor students and trainees under the guidance of the PI

Recruiting and pre-screening study participants; reviewing patient eligibility with Study PIs and managing study enrollment

Ensuring that inquiries made to the study phone and e-mail account are responded to in a timely fashion.

Printing recruitment material for distribution and collating responses

Scheduling study visits

Liaison with other study personnel

Assisting in training study staff in visit-specific procedures

Maintaining SOPs for visit-specific procedures

Reviewing CRFs for completeness after each study visit.

Creating and maintaining clinical report forms (CRFs) and ensuring that the correct CRFs are completed at each study visit.

Assists in sending texts and email reminders to participants.

Storing and maintaining the security of all source documentation.

Working with the study team to main version control of all study related documents.

Assists in monitoring the patient recruitment and retention across the study sites

Reporting to the PI and team at monthly meeting.

May also participate in phone screening, recruitment and study visits as needed.

Assists in preparing ad hoc reports for the investigative team as requested.

Cleaning data at intermittent periods throughout the study, scoring survey instruments where necessary, and locking the dataset at the completion of the study.

Required Qualifications*

Comfortable working with a diverse study team and patient populations

Capable of working with multidisciplinary professionals

Bachelor's Degree or higher preferably in health science or health related field

At least five years of experience coordinating clinical research or equivalent experience

Excellent interpersonal, oral, and written communication skills with exceptional attention to detail

Excellent computer skills including proficiency in Microsoft software applications (email programs MS Word, MS excel) as well as Qualtrics and SPSS.

Excellent organizational skills including the ability to multi-task and work well under time constraints and deadlines

Willingness to be flexible in a dynamic working environment

Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner

Must have access to a reliable vehicle to get to community-based clinics is required

Must be flexible with work schedule and some weekend work required

Experience recruiting study participants

Desired Qualifications*

Knowledge of U of M Health System policies and procedures

Knowledge of data processing including building databases, entering data and cleaning data

Knowledge of IRB and regulatory issues pertaining to multi-site clinical studies

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.