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Clinical Protocol Writer Jobs (NOW HIRING)

Monitor and train clinical protocol coordinators in accurate and timely data collection.Provide ... written instructions and established proceduresAbility to function independently and manage own ...

You will also have the opportunity to participate in the protocol development, clinical development ... Writing. * Support Alliance Management activities by preparing technical updates and data summaries ...

You will also have the opportunity to participate in the protocol development, clinical development ... Writing. * Support Alliance Management activities by preparing technical updates and data summaries ...

Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD ... clinical summaries, and integrated summaries of safety and efficacy. * The ability to accurately ...

In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives. * Compiles, edits, and submits written reports for both internal and external administrative ...

In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives. * Compiles and edits written reports for both internal and external administrative offices.

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Clinical Protocol Writer information

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$25

$54

$83

How much do clinical protocol writer jobs pay per hour?

As of Jun 7, 2026, the average hourly pay for clinical protocol writer in the United States is $54.35, according to ZipRecruiter salary data. Most workers in this role earn between $39.90 and $64.18 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Clinical Protocol Writer position, and why are they important?

To thrive as a Clinical Protocol Writer, you need expertise in clinical research, scientific writing, and regulatory requirements, typically supported by a bachelor's or advanced degree in life sciences or a related field. Familiarity with tools like Microsoft Office, clinical trial management systems (CTMS), and knowledge of ICH-GCP guidelines or similar certifications are highly valued. Strong attention to detail, collaboration skills, and the ability to translate complex scientific concepts into clear, compliant documents set top candidates apart. These skills are essential for generating precise, regulatory-ready protocols that ensure accurate clinical trial execution and cross-team collaboration.

What are the typical daily responsibilities of a Clinical Protocol Writer?

A Clinical Protocol Writer is responsible for drafting and revising clinical trial protocols, ensuring compliance with regulatory guidelines, and incorporating feedback from cross-functional teams such as clinical operations, biostatistics, and regulatory affairs. On a typical day, you may coordinate with investigators, review scientific literature, and attend meetings to discuss study design and objectives. You’ll also manage document version control and ensure timely delivery of protocol drafts and amendments. This role requires balancing independent writing tasks with frequent team collaboration to align clinical documentation with study goals and regulatory standards.

What is a Clinical Protocol Writer job?

A Clinical Protocol Writer is responsible for drafting and developing clinical trial protocols that outline study objectives, methodologies, patient eligibility criteria, and regulatory requirements. They work closely with clinical researchers, regulatory teams, and medical writers to ensure protocols align with industry and compliance standards. Their role is crucial in guiding the execution of clinical trials and ensuring data integrity. Strong writing, attention to detail, and knowledge of regulatory guidelines are essential for success in this role.

What are the most commonly searched types of Clinical Protocol Writer jobs? The most popular types of Clinical Protocol Writer jobs are:
Infographic showing various Clinical Protocol Writer job openings in the United States as of May 2026, with employment types broken down into 89% Full Time, and 11% Part Time. Highlights an 51% Physical, 2% Hybrid, and 47% Remote job distribution, with an average salary of $113,048 per year, or $54.4 per hour.
Clinical Research Nurse

Clinical Research Nurse

Loyola University

Maywood, IL • On-site

Other

Posted 21 hours ago


Job description

Clinical Research Nurse

As a Jesuit, Catholic institution of higher education, we seek candidates who will contribute to our strategic plan to deliver a Transformative Education in the Jesuit tradition. To learn more about Loyola University Chicago's mission, candidates should consult our website at www.luc.edu/mission/. For information about the university's focus on transformative education, they should consult our website at www.luc.edu/transformativeed.

Position Details

Job Title - CLINICAL RESEARCH NURSE

Position Number - 8150207

Work Modality - Hybrid – 4 In-Person

Is this request for the creation of a new Position (or the modification of an existing Position) to temporarily support the WorkDay ERP? - new

Job Category - University Staff

Job Type - Full-Time

FLSA Status - Non-Exempt

Campus - Maywood-Health Sciences Campus

Department Name - HEMATOLOGY ONCOLOGY

Location Code - HEMATOLOGY - ONCOLOGY (06508A)

Is this split and/or fully grant funded? - Yes

Duties and Responsibilities - Planning and implementation clinical trial to include but not limited to coordination with all members/ departments/ external institutions of the study team, oversight ofIRB, regulatory and/orFDAsubmissions, budget preparation participation, and study management tool development. Provide education and training to other health care professionals related to patient participation in a clinical trial.Screening, recruitment, and enrollment of study participants. Procure eligibility data and materials, interface with sponsors, investigators as appropriate in determining eligibility.Oversee study lab specimen collection, processing and shipping, and long term data collection.Prepare and participate in Cooperative Group Audits,NCI,FDA, SponsorGCPquality audits, Loyola internal audits and department audits.Participation in program research planning to include as appropriate, protocol development, data reporting and grant reporting. Participate in Departmental Process Improvement Activities, National Committees appropriate.Collaborates with the PI in the case management of protocol patients; assuring patient safety and compliance with the protocol and regulatory requirements and patient billing compliance. Communicates with the appropriate clinical staff in coordination of patient care.Data management; collecting, data entry of accurate data. Monitor and train clinical protocol coordinators in accurate and timely data collection.Provide oversight and guidance to clinical protocol coordinators regarding several research protocolsIRBsubmissions and regulatory management.Perform other duties as assigned.

Minimum Education and/or Work Experience - Minimum Education:Required: Bachelors Degree OR equivalent training acquired via work experience or educationPreferred: Bachelors Degree Specify Degree(s): NursingMinimum Experience:Required: 1-2 years of previous job-related experiencePreferred: 3-5 years of previous job-related experience

Qualifications - Ability to communicate verballyAbility to compile complex reports and develop presentationsAbility to compose letters and memorandumsAbility to deal calmly and courteously with peopleAbility to deal with stressful situationsAbility to finish tasks in a timely mannerAbility to follow oral and written instructions and established proceduresAbility to function independently and manage own time and work tasksAbility to lead work teamsAbility to maintain accuracy and consistencyAbility to maintain confidentialityAbility to maintain office files and follow standard office proceduresAbility to negotiate, persuade and establish directionAbility to organize workflowAbility to plan, coordinate and develop multiple projectsAbility to work as an effective team memberWork consists of various duties involving different processes and methods. Factors to be considered differ with each assignment, and elements of the work must be identified and analyzed to determine appropriate action. Moderate impact on a limited phase of Loyola activity. Significant impact on the life and health of students or patients. General administrative policies exist, but employee is required to use expertise & judgment to meet objectives. Loyola is committed to providing care that is safe. It is expected that all Loyola employees will perform their job function in a professional and competent manner that constantly seeks to reduce the risk of harm to patients, families and co-workers. Loyola is committed to the continuous improvement of the services it provides to its patients and their families. All Loyola employees are expected to participate in quality improvement activities. Responsible for consistently demonstrating our Magis values of Care, Concern, Respect and Cooperation through teamwork and effective communication in an effort to prevent and solve problems and to achieve quality outcomes, patient safety, customer satisfaction and a safe environment. Responsible for developing and maintaining an environment of service excellence as outlined in the Service Excellence standards.Patient Population Specific Competencies:Demonstrates the skills and knowledge necessary to provide appropriate care to the patient populations served by the specific unit to which the incumbent is assigned.Must be able to assess data reflective of the patient's status and interpret appropriate information needed to identify each patient's requirement relative to population specific needs.The primary patient population for the unit is Oncology and Research.Personal Relationships: Skilled job requiring high level of adaptability & interpersonal skillsInternal Contacts: Within Department, Cross-departmental, Physicians, Management, Faculty, Physician Assistants, Adv Practice Nurses.External Contacts: Patients, Families, Regulatory Agencies, Other healthcare agencies

Certificates/Credentials/Licenses - Registered Nurse, Illinois licenseMinimum Education:Required: Bachelors Degree OR equivalent training acquired via work experience or educationPreferred: Bachelors Degree Specify Degree(s): NursingMinimum Experience:Required: 1-2 years of previous job-related experiencePreferred: 3-5 years of previous job-related experience

Computer Skills - Must be proficient in Microsoft Office suite of programs. Experience with electronic medical record (EMR), preferably Together Care orEPIC.

Supervisory Responsibilities - No

Required operation of university owned vehicles - No

Does this position require direct animal or patient contact? - Yes

Physical Demands - None

Working Conditions - None

Open Date - 03/05/2026

Close Date

Position Maximum Salary or Hourly Rate - $40.87/hr

Position Minimum Salary or Hourly Rate - $36.06/hr

Special Instructions to Applicants - As a Jesuit, Catholic institution of higher education, we seek candidates who will contribute to our strategic plan to deliver a Transformative Education in the Jesuit tradition. To learn more about Loyola University Chicago's mission, candidates should consult our website atwww.luc.edu/mission/. For information about the university's focus on transformative education, they should consult our website atwww.luc.edu/transformativeed.

About Loyola University Chicago - Founded in 1870, Loyola University Chicago is one of the nation's largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact. With15 schools, colleges, and institutes—including Business, Law, Medicine, Nursing, and Health Sciences—Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Consistently ranked among the nation's top universities by U.S. News & World Report, Loyola is aSTARSGold-rated institution that is ranked as one of the country's most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world.Loyola University Chicago strives to be an employer of choice by offering its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. To view our benefits in detail,click here.Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University'sNondiscrimination Policy.