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Job Summary

Under direct supervision of a manager, oversees a portfolio of research projects in development. Responsible for all aspects of the project through to activation, and business assurance requirements. Responsible for coordinating with the principal investigator, study team, research administration, clinical services and external partners to prepare, evaluate and implement research studies. To effectively coordinate the activities of the team and project, competency and familiarity are necessary with research methods, project management, and the roles and functions of teams throughout the system.

Essential Functions

+ Serves as project manager focused on start-up activities for a variety of research studies with various levels of regulatory, clinical, and operational complexity.

+ Supports the Principal Investigator and research team members and is accountable to external sponsors for communications and updates related to study progress.

+ Evaluates and prepares research studies for implementation. This includes leading activities such as the site selection process, review of sponsor provided study documentation, completing tools to support budget negotiation, and partners with clinical and nonclinical teams to support decision making.

+ Leads and supports the service line and departmental vetting processes by providing summary analysis of the operational feasibility of the study.

+ Prepares Internal Review Board application documentation which includes development of consent forms, communication with Sponsor on development updates and timelines, facilitates and attends meetings, and communicates to internal teams throughout the life cycle of development.

+ Communicates, collaborates, networks, and acts as a consultant to the study sponsor and contract research organization, research study centers, academic institutions, investigators, physician offices, ancillary departments, and the multidisciplinary team.

+ Partners with sponsor and study team to ensure post activation essential documentation maintenance requirements are met in accordance with federal laws, rules and regulations and local policies and procedures to follow to ensure compliance.

+ Provides ongoing regulatory maintenance in departmental systems and in coordination with sponsor, and consulting on documentation changes.

+ Tracks metrics and milestones related to project development using research enterprise systems and tools to ensure timely delivery and utilization of project management methodology.

Qualifications

Required

+ Bachelor’s degree in health or science related, or equivalent

+ 2 year of relevant experience in clinical research and project management

+ Collaboration Institute Training Initiative certification required within 90 days of employment

+ Good Clinical Practice certification required within 90 days of employment

About Corewell Health

As a team member at Corewell Health, you will play an essential role in delivering personalized health care to our patients, members and our communities. We are committed to cultivating and investing in YOU. Our top-notch teams are comprised of collaborators, leaders and innovators that continue to build on one shared mission statement - to improve health, instill humanity and inspire hope. Join a nationally recognized health system with an ambitious vision of continued advancement and excellence.

How Corewell Health cares for you

+ Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here (https://careers.corewellhealth.org/us/en/benefits-new) .

+ On-demand pay program powered by Payactiv

+ Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!

+ Optional identity theft protection, home and auto insurance, pet insurance

+ Traditional and Roth retirement options with service contribution and match savings

+ Eligibility for benefits is determined by employment type and status

Primary Location

SITE - Secchia Center - 15 Michigan St - Grand Rapids

Department Name

Research Development - GR

Employment Type

Full time

Shift

Day (United States of America)

Weekly Scheduled Hours

40

Hours of Work

8:00 a.m. to 5:00 p.m

Days Worked

Monday to Friday

Weekend Frequency

Variable weekends

CURRENT COREWELL HEALTH TEAM MEMBERS – Please apply through Find Jobs from your Workday team member account. This career site is for Non-Corewell Health team members only.

Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.

Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.

An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team.

You may request assistance in completing the application process by calling 616.486.7447.