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CLINICAL RESEARCH PROJECT MANAGER

CLINICAL RESEARCH PROJECT MANAGER

DISCIPLINE Speech-Language Pathology

 

CLINICAL RESEARCH PROJECT MANAGER

 

Job ID: 45157

 

Job Summary:

 

Manages all activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).

 

Specific Responsibilities:

 

Technical

 
  • Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.
  • Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
  • Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors. Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
 

Administrative

 
  • Analyzes, evaluates & interprets data to determine relevance to research.
  • Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
 

Data

 
  • Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
  • Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
 

Finance

 
  • Monitors accounts.
  • Purchases supplies, materials, equipment & services.
  • Ensures appropriate allocation & compliance.
  • Invoices study sponsors for study tests/procedures.
 

Supervision

 
  • Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows.
  • Acts as a mentor in regard to education of junior coordinators.
 

Miscellaneous

 
  • Performs other duties as assigned.
 

Minimum Qualifications: 

 
  • Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required; OR
  • Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 3 years' research study or other relevant experience.
  • Supervisory or project management experience required.
  • Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.
 

Preferred Qualifications:

 
  • Certificate of Clinical Competency (CCC) in Speech-Language Pathology
  • Experience with recruiting, consenting, screening, and scheduling research participants
 

Preferred Competencies: (Skills, knowledge, and abilities)

 
  • Registered MBSImP clinician
  • Experience with REDCap
  • Experience with Epic (or equivalent EMR)
 


 

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

 

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

 

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

 


Northwestern requires all staff and faculty to be vaccinated against COVID-19, subject to limited exceptions. For more information, please visit our COVID-19 and Campus Updates website.

 

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.

 

Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Click for information on EEO is the Law.

 





Additional Info

Contact Name : Bonnie Martin-Harris

Contact Address : 2240 Campus Drive
Evanston, IL 60208

Contact Email : csdchair@northwestern.edu

Contact Phone : 847-491-3066

Instructions : To view the job posting and/or apply for the job, click here

https://careers.northwestern.edu/psp/hr857prd_er/EMPLOYEE/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=1&JobOpeningId=45157&PostingSeq=1

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