Research Area Specialist Sr

Michigan Medicine; Ann Arbor (MI); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Excellent health coverage

Retirement match 2:1

Hybrid/remote work options

Job summary

Michigan Medicine is seeking an experienced clinical researcher to support NIH funded multi-site trials within the Division of Pulmonary and Critical Care Medicine. You will develop essential study documents, manuals, and onboarding procedures for contracting and training across sites, ensuring high-quality data collection.

The role requires at least 5 years of clinical research experience, a Masters degree, and familiarity with Oncore, MiCHART, and REDCap.

Qualifications

• Masters degree or higher is required or equivalent experience.
• Minimum of 5 years of clinical research experience.
• Experience authoring/editing manuscripts, posters, abstracts.
• Experience with eResearch and regulatory submissions.
• Familiarity with Oncore and MiCHART systems.
• Understanding of study/grant financials and budgeting.
• Mentorship or supervisory experience; willingness to travel ~1–3 times/yr.

Responsibilities

• Lead NIH-sponsored multi-site trial across 10–15 sites.
• Develop essential study documents, tools, manuals, and processes.
• Build REDCap registry and guidance for data collection.

Skills

Clinical research

Mentorship / leadership

Regulatory documentation

Grant writing support

Travel willingness

Education

Master's degree or higher

ACRP/SOCRA certification desirable

Tools

Oncore

MiCHART

REDCap

Job description

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.

Job Summary

The Division of Pulmonary and Critical Care Medicine is seeking someone experienced in clinical research to support an NIH funded multi-site projects The investigator works primarily within cystic fibrosis and bronchiectasis therapeutic areas so experience with pulmonary diseases and testing will be very helpful. This position will work closely with the Program Director to launch an NIH funded multi-site trial, where Michigan Medicine is the data coordinating and clinical coordinating center, by developing essential study documents, manuals, procedures, and onboarding sites by facilitating contracting, training etc. The study evaluates outcomes for patients randomized to two different standard-of-care treatments. Once the project is launched this position will be the primary point of contact for issues related to study operations and coordinate/manage bi-annual DSMB meetings. Other duties will include working with the Program Director to identify funding opportunities and develop grant applications accordingly, providing necessary reporting to various funders, assisting with development of manuscripts, abstracts, posters etc., and collaborating in the planning and execution of strategic initiatives of the program.

Responsibilities

• Lead all aspects of an NIH sponsored multi-site investigator initiated trial encompassing 10-15 sites
• Develop all necessary essential study documents, tools, manuals, processes etc.
• Build RedCap registry and any necessary guidance documents to facilitate accurate and high quality data collection
• Facilitate DSMB review for the project and participating sites
• Serve as primary point of contact for study-related issues and needs
• Onboard participating sites by facilitating contract execution and registry access
• Train participating sites in study related procedures and data collection
• Manage data quality for participating sites
• Liaise with biostats support regarding aims of project and analysis
• Conduct project meetings that include participating sites

Regulatory Support

• Complete new study applications, continuing reviews, event reporting as needed in support of the program portfolio
• Liaise with study sponsors to provide necessary regulatory documents for study start-up and close-out
• Work with central IRBs as needed to facilitate study approvals

Support Program Growth And Visibility

• Provide input on grant proposals and applications;
• Assist with identifying funding opportunities and/or relevant clinical trials to ensure a well-rounded portfolio
• Assist with the development of manuscripts, posters, abstracts by writing specific portions, performing literature reviews etc.
• Attend network, society and other national meetings representing the program
• Present posters, abstracts etc. as needed

Administrative Duties

• Assisting with planning/scheduling program meetings as needed
• Sit in on financial meetings and work to conceptually understand impact of financial decisions
• Complete all necessary training required by institution, networks, sponsors etc.
• Work with Program Director to develop plans and strategies to facilitate growth of the program?s portfolio, assist with execution of strategic initiatives
• Other duties as assigned and/or agreed upon with Program Director

Required Qualifications

• Masters degree or an equivalent combination of education and experience is necessary.
• Minimum of 5 years of clinical research experience
• Experience authoring and/or editing portions of manuscripts, posters, abstracts
• Prior experience with eResearch and preparation of new study applications, event reporting, continuing reviews, etc.
• Experience working in Oncore and MiCHART
• Demonstrated understanding of study/grant financials to the extent that candidate can ensure good stewardship of study/grant funds
• Prior experience providing mentorship and/or functional oversight
• Willingness to travel to national meetings and conferences as needed; approx. 1-3 times per year

Desired Qualifications

• Experience assisting with the development of grant proposals/applications and funder reporting
• Experience with pulmonary disease populations
• Experience with NIH funded trials
• Experience with multi-center investigator initiated trials
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

This position is hybrid, with on-site work required as needed. Work hours are Monday to Friday from 8:00 am to 5:00 p.m. There will be some travel to national meetings

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.