Scheduled Hours

40

Position Summary

Assists faculty in developing documents to guide the conduct of investigator initiated clinical research. Possesses detailed knowledge of protocol development, research operations regulatory compliance, data collection mechanisms and both internal and external policies and procedures regulating the conduct of clinical research.

Job Description

Primary Duties & Responsibilities

Develop Protocol

• Develops protocol-related documents, source documents and data collection forms for investigator-initiated research protocols.
• Coordinates and participates in initial protocol team meetings with appropriate investigators and staff.
• Revises investigator-initiated protocols, informed consents, source documents, data collection forms and all other protocol-related documents as per investigator suggestions and review committees requirements.
• Submits Investigational New Drug (IND) applications with FDA and communicates with FDA as appropriate.
• Assists investigators and research staff in complying with a broad range of applicable regulations and informs research personnel about new policies and procedures, answers questions and finds solutions to problems.
• Creates case report forms (CRFs) and specifically defined electronic databases (e.g., Siteman Cancer Center Administrative Database and SCIP â“ Siteman Cancer Informational Portal) for data collection for investigator-initiated protocols.
• Enters data plan into electronic data capture system.
• Maintains and manages electronic study files for investigator-initiated trials.
• Develops clear timelines for data submission.
• Reviews draft forms with study coordinator(s) to ensure feasibility and appropriateness of data plan.
• Manages and maintains the integrity and confidentiality of the data.
• Reviews and revises data collection forms and electronic data capture system when needed.

Facilitate Multi-Center Study Coordination / Coordination of Investigator Initiated Protocols

• Assists investigators and research staff in complying with a broad range of applicable regulations and informs research personnel about new policies and procedures, answers questions and finds solutions to problems.
• Develops and submits new study paperwork, including Protocol Review and Monitoring Committee (PRMC) Forms and Institutional Review Board (IRB) (known as the Human Research Protection Office or HRPO) forms. Ensures that new submissions comply with all applicable requirements (e.g., appropriate signoffs, forms, etc.) and communicates with investigators, research staff and study sponsors (if applicable).
• Responds to PRMC and HSC review contingencies.
• Completes, reviews with investigators and study staff and submits renewal paperwork for studies, including PRMC and IRB-HSC paperwork and interim reports.
• Completes, reviews with investigators and study staff and submits amendment paperwork for studies.
• Processes other protocol and consent-related actions.
• Provides requested study-related information to investigators, study staff, PRMC, HSC, FDA, study sponsors and other entities.

Other Functions

• Registers study to clinicaltrials.gov.
• Maintains protocol-related records and performs additional administrative functions.
• Prepares study-related and other reports (e.g., renewal report, pending studies report).
• Records and reports time, workload and productivity efforts.
• Assists in development and implementation of policies and procedures for CTC operations and processes.
• Participates in special CTC projects, as assigned.
• Attends staff and regulatory coordinator meetings, unless excused by the supervisor.
• Attends appropriate training sessions (e.g., database) and other meetings as necessary.
• Ensures regulatory requirements (per PRMC guidelines) are included in multi-center protocols.
• Communicates with multi-center sites and distribute documents.
• Collects documentation from other sites, including documentation of FWA, 1572, cvs, human studies training, IRB approvals, etc.

Preferred Qualifications

• SOCRA or ACRP certification.
• Experience working in a health care environment.
• Familiarity with oncology terminology a plus.
• Previous clinical trials and/or research experience.
• Investigator-initiated and/or cooperative group trial experience.
• Ability to learn quickly and work independently and efficiently with minimal supervision.
• Ability to independently prioritize tasks and to work well under deadline pressure.
• Excellent verbal and written communication skills.
• Ability to interact effectively with a wide variety of individuals, including clinical investigators, regulatory, clinical, administrative and support staff and representatives from cooperative groups, other institutions and pharmaceutical companies.
• High attention to detail.
• Strong organizational and computer skills.

Required Qualifications

• Bachelorâ™s degree or equivalent training and experience.
• Familiarity with the regulatory and/or operational side of clinical research, as well as with the human subject protection system.
• Basic medical terminology.

Grade

C10

Salary Range

$52,600.00 - $78,900.00 / Annually

The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.

Questions

For frequently asked questions about the application process, please refer to our External Applicant FAQ.

Accommodation

If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

Pre-Employment Screening

All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.

Benefits Statement

Personal

• Up to 22 days of vacation, 10 recognized holidays, and sick time.

• Competitive health insurance packages with priority appointments and lower copays/coinsurance.

• Want to Live Near Your Work and/or improve your commute? Take advantage of our free Metro transit U-Pass for eligible employees. We also offer a forgivable home loan of up to $12,500 for closing costs and a down payment for homes in eligible neighborhoods.

• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.

Wellness

• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!

Family

• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? Weâ™ve got you covered.

• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/

EEO/AA Statement

Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the Universityâ™s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.

Diversity Statement

Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment â“ fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

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