Clinical research specialist

Full job description

Scheduled Hours

40

Position Summary

Position oversees and coordinates complex clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation of clinical research; responsible for preparation of budgetary reports and ensures billing and regulatory compliance standards are maintained; may supervise clinical research staff.

Job Description

Primary Duties and Responsibilities

• Assists in protocol development, budget development, dispensing of study funds for multi-clinical research projects; invoicing; provides high level of direct and indirect support.
• Directs the planning, implementation and coordination of clinical trials sponsored by industry, government, non-profit foundations, or private organizations and serves as the established point of contact for the study; prompts communications to ensure the shortest possible timeframes for start-up.
• Tracks in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, regulatory documents, and other study-start-up requirements in partnership with the study PI and study team.
• Works with PI to design, perform, and evaluate research procedures; confers with PI to assist in developing plans for research projects and discuss the interpretation of results; collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
• Serves as a resource to the clinical research staff, ensuring appropriate procedures, and explains policies and procedures; ensures that research projects are completed according to IRB and federal guidelines.
• Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; may participate in the hiring, training, and evaluation of clinical research staff.
• Provides Study Coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols.
• Researches and recommends new methods and procedures to maintain standards and improve quality.

Preferred Qualifications

• At least four years of experience in clinical research coordination.
• Experience working as a lead coordinator on FDA device (IDE/IVD) trials.
• Effective analytical, problem-solving and organizational skills.
• Ability to communicate in oral and written form with all levels of personnel.
• Ability to work independently and prioritize tasks in a diverse environment.
• Demonstrated leadership and interpersonal skills.
• Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database management and spreadsheet development.

Required Qualifications

Bachelor of Science degree plus four years of clinical or research experience with at least one year of lead or supervisory experience included; eight years of relevant education and work experience may substitute for this requirement.

Grade

C13

Salary Range

$66,700.00 - $103,400.00 / 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 or call the dedicated accommodation inquiry number at 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? 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:

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 University’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 – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.