Medical Writer (Clinical Research Project Manager)

Department: MED-Cancer Center
Salary/Grade: EXS/7

Target hiring range for this position will be between be $65,000-$78,000. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Job Summary:

The Medical Writer will be an integral part of the clinical research team, primarily responsible for assisting investigators with the development and maintenance of investigator-initiated cancer clinical research protocols. This position will provide support to the Cancer Center members and the interdisciplinary Disease Sections by collaborating with individual investigators to produce high quality clinical trials assuring compliance with federal regulations.

Specific Responsibilities:

• Responsible for developing the non-scientific portions of a standard research protocol (such as registration, record-keeping and regulatory compliance sections). Collaborate with the investigator to draft non-scientific/clinical aspects including project scope. Review the entire protocol document for consistency, clarity, formatting and correct grammar. May assist with Letter of Intent and Informed Consent Form development.
• Serve as primary contact for revisions to the protocol document during the submission and approval processes (including funding source, FDA, SRC, and/or IRB). Edit documents with future revisions/amendments to the study. Prepare the summary of changes, may responding to any queries about the changes during the approval process.
• Maintain and distribute updated versions of the protocol throughout the protocol life cycle.
• Monitor the trial status and respond to inquiries from investigators, affiliates, supporting agencies, CRO staff, etc. Research questions regarding other aspects of trial activation and/or direct questions to the appropriate personnel. Answer questions from regulatory staff about the CTRP or ClinicalTrials.gov registration of these trials and assisting the study team at the time of results reporting to ClinicalTrials.gov.
• Maintain and update protocol templates.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• BA or BS with a minimum of 2 years of relevant scientific writing experience or the equivalent combination of education, training and experience from which similar skills can be acquired.

Minimum Competencies: (Skills, knowledge, and abilities.)

ACC,

ATTDET,

COACH,

COMPLIAN,

DEP,

ORG,

EFF,

COW

Preferred Qualifications:

• An advanced degree (MA, MS, PhD) or the equivalent combination of education, training and experience from which comparable skills can be acquired

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 University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.