Manager Clinical Trials (Hybrid) - Radiology

Washington University in St. Louis; St. Louis (MO); On-site; USD 75,000 - 129,000; Full time

Benefits offered by this job

Vacation and holidays

Health insurance

Transit benefit

Retirement plan

Job summary

Washington University in St. Louis in Saint Louis, MO, seeks a Clinical Research leadership role within the Radiology Department's Theranostics program to manage radiopharmaceutical trials and clinical imaging studies.

You will supervise research coordinators, coordinate protocols, budgets, and regulatory submissions, and collaborate with sponsors, clinicians, and administrative leaders to advance oncology radiopharmaceutical trials.

Qualifications

• Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
• Clinical Research experience (1 year) required.
• Certifications in clinical research are preferred but not required.

Responsibilities

• Leads the Functional Research Groups and makes staffing decisions with input from Directors.
• Orients and trains staff in multiple groups and conducts regular supervision.
• Plans budgets and coordinates protocols for new studies.
• Ensures regulatory compliance and quality data collection across studies.
• Oversees daily activities of Senior Research Coordinators and monitors protocol adherence.
• Facilitates accrual to high-priority research studies.
• Represents groups in senior level meetings and with oncologists.

Skills

Clinical Project Management

Clinical Trials Administration

Microsoft Excel

Microsoft Word

Oncology Research

Radiopharmaceuticals

SQL Databases

Education

Bachelor's degree

Tools

SQL Databases

Job description

Location

SAINT LOUIS, MO 63110

Scheduled Hours

40

Position Summary

This position will be housed in the Department of Radiology, in the clinical research group of Dr. Richard Wahl. Mallinckrodt Institute of Radiology’s clinical theranostics program provides personalized medical management through targeted radiopharmaceutical diagnosis and therapy.

The selected candidate will work collaboratively and directly with the Center for Clinical Theranostics Research (CCTR) managing radiopharmaceutical clinical trials led by Dr. Wahl. The relevant individual will also work on diagnostic imaging trials led by Dr. Wahl, working with the Center for Clinical Imaging Research. The position is directly responsible for the supervision, oversight, training and education of research coordinators and may have direct interactions with commercial sponsors and, on occasion, patients. The position requires the ability to assess protocols for budgetary and logistical issues associated with the coordination and implementation of oncology radiopharmaceutical trials as well as regulatory issue. Additional components of the position include regulatory submissions, finances, and leadership of clinical research staff.

Primary Duties & Responsibilities

Leadership Of The Functional Research Groups:

• Makes hiring and staffing decisions in the Functional Research Groups with input from the Administrative and Medical Directors of the Core.
• Orients and trains all staff in the Functional Research Groups, and assists in orienting new staff in the Regulatory and Protocol Development groups.
• Meets regularly with all staff, providing supervision and training.
• With the Administrative Director and Medical Director, strategically plans and implements plans for Functional Research Groups, including staffing (setting current and future a appropriate staff levels), education, adherence to federal regulations and standard operating procedures for ensuring quality data collection.
• Provides feedback and performs annual performance evaluations for Research Coordinators with assistance from Senior Clinical Research Associates and the Administrative Director.
• Supports Senior Clinical Research Associate through initial performance improvement efforts and directs progressive performance management and disciplinary activities as required.
• Assesses new protocols for logistical and budgetary issues and creates a plan to address these.
• Creates budgets for new studies.
• Assists with evaluating and entering studies into the database.
• Meets regularly with Administrative Director (at least weekly, but probably more often); represents Functional Research Groups at senior level meetings.
• Meets regularly with the oncologist to assess the progress and goals of the research program.
• Leads regular meetings with the study team and members of each clinical area to plan for the successful implementation of upcoming studies.

Oversight Of Daily Activities:

• Oversees the daily research activities for Senior Research Coordinators including compliance with protocol criteria and adherence to federal regulations.
• Oversees daily protocol management activities of Senior Research Coordinators.
• Monitors collected data for accuracy of objective criteria.
• Facilitates accrual to high priority research studies.
• Oversees the quality assurance process for monitoring the collection of data for research, with assistance from the Quality Assurance and Safety Monitoring Committee (QASMC).
• Performs other duties as assigned.

Working Conditions

• Normal office environment.

Physical Effort

• Typically sitting at desk or table.
• Repetitive wrist, hand or finger movement (PC Typing).

Equipment

• Office equipment.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Education

Required Qualifications

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications/Professional Licenses

No specific certification/professional license is required for this position.

Work Experience

Clinical Research (1 Year)

Skills

Not Applicable

Driver's License

A driver's license is not required for this position.

Preferred Qualifications

• Experience in nuclear medicine clinical trials could complement experience in general and oncologic clinical trials.

Education

Preferred Qualifications

No additional education unless stated elsewhere in the job posting.

Certifications/Professional Licenses

Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinical Research Professionals (ACRP), Clinical Research Professional (CRP) - Association of Clinical Research Professionals (ACRP)

Work Experience

No additional work experience unless stated elsewhere in the job posting.

Skills

Clinical Project Management, Clinical Systems, Clinical Trials Administration, Deadline Management, Interpersonal Relationships, Leadership, Microsoft Excel, Microsoft Word, Oncology Research, Oral Communications, Prioritization, Radiopharmaceuticals, SQL Databases, Stress Management, Written Communication

Grade

G14

Salary Range

$75,200.00 - $128,800.00 / 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 [e-mail] or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.

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.
• Take advantage of our free Metro transit U-Pass for eligible employees.
• 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? We’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 Statement

Washington University in St. Louis is committed to the principles and practices of equal employment opportunity. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, citizenship (where prohibited by federal law), age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.