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Clinical Research Project Manager
2 months ago
Salary/Grade: NEX/11
Position Overview:
This role offers a unique opportunity to collaborate with the inpatient critical care team, assess intricate medical cases, and execute cutting-edge clinical trials focused on pneumonia, COVID-19, and sepsis.
Responsible for overseeing the collection, analysis, processing, and reporting of research data while assisting the Principal Investigator (PI) in evaluating the integrity of test data related to biomedical and/or social-behavioral research studies of moderate complexity involving co-investigators across multiple campuses and/or institutions. All tasks must be completed in strict adherence to Good Clinical Practices (GCP) and all applicable local, state, and federal laws, regulations, guidelines, policies, and procedures established by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).
Note: The supervisor will provide objectives, deadlines, and specific instructions primarily for new, challenging, or unusual tasks. Work will be reviewed upon completion and occasionally to ensure technical accuracy and compliance with practice, policy, and procedures. The employee is expected to keep the supervisor informed of ongoing progress and any potentially contentious issues.
Key Responsibilities:
Technical
- Engage in the planning and execution of research studies, including participant recruitment and retention.
- Secure informed consent from participants.
- Administer assessments and/or surveys in accordance with established protocols.
- Collect, compile, tabulate, and process participant responses.
- Gather relevant information.
- Extract and analyze data from medical records.
- Perform basic clinical tasks such as blood draws and measuring blood pressure.
- Collect, document, review, and summarize research data.
- Organize relevant statistical results and create tables, charts, and graphs to illustrate relationships among various tests.
- Prepare reports for investigators and sponsors detailing recruitment status and other significant study data.
- Contribute to grant applications and co-author scientific publications.
- Complete documentation in compliance with current local, state, and federal regulatory standards, requirements, laws, and research protocols.
- May handle payments for research participants as per study protocols.
- Collaborate with industry representatives to negotiate preliminary grant funding.
- Manage reimbursements for expert panel travel, consultant fees, additional gift card orders, etc., ensuring expenses remain within the designated grant budget.
- May provide guidance and/or training to other research staff on participant interviewing/testing.
- May serve as a mentor for the education of junior coordinators.
Perform additional 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 a suitable combination of education and experience along with 2 years of 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 a suitable combination of education and experience.
- Must complete NU's IRB CITI training prior to interacting with any participants and must re-certify every 3 years.
- Ability to obtain American Heart Association or American Red Cross Healthcare certification in cardiopulmonary resuscitation (CPR).
- Ability to fulfill the requirements of the Northwestern Memorial Research Access Program.
- Proficiency in specimen processing/handling.
- Proficiency in Microsoft Office applications, including Excel, Outlook, and Word.
- Familiarity with medical terminology.
- Knowledge of hospital medical records.
- Prior experience with inpatient medical records.
- Prior experience in clinical research protocol development.
- Prior experience with data entry systems, e.g., REDCap.
- Certification as a clinical research coordinator (ACRP or SOCRA).
- Phlebotomy certification and prior experience as a phlebotomist.
- Action-oriented - Proactive in addressing problems or situations.
- Coachability - Open to feedback, eager to learn, and committed to continuous improvement.
- Collaboration - Promotes effective communication, cooperation, and teamwork within and beyond one's own team.
- Collegiality - Approachable, respectful, and supportive; fosters strong working relationships and a positive work environment.
- Initiative - Demonstrates energy and ambition to achieve; sets high goals and takes decisive action to enhance job outcomes and prevent issues.
- Deadline-oriented - Consistently meets deadlines with success.
- Multi-tasking - Capable of managing multiple projects simultaneously.
- Organizational skills - Efficiently plans, organizes, and schedules tasks; anticipates challenges and pays attention to detail.
Benefits:
Northwestern is committed to providing meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts, and more.
Work-Life and Wellness:
Northwestern offers comprehensive programs and services to assist you and your family in navigating life's challenges and opportunities while promoting healthy lifestyles. Flexible work arrangements are supported where feasible, along with programs to help locate and afford quality childcare and senior/adult care.
Professional Growth & Development:
Northwestern encourages employee career development in all circumstances, whether working on campus or remotely. For those interested in enhancing their professional potential or pursuing further education, a variety of tools and resources are available.
Northwestern strongly advocates for COVID-19 vaccinations and boosters for individuals who can receive them as a vital measure to reduce severe illness.
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.
