clinical research specialist - Saint Louis, MO, United States - Washington University in St. Louis

Description

Scheduled Hours

40

Position Summary

The responsibility of the Clinical Research Specialist is to direct and coordinate all aspects of multi-center clinical research trials, which include tactical management, administration and leadership of project teams to ensure the project milestones proceed on time and within budget parameters.

To accomplish this, the Clinical Research Specialist will collaborate closely with the clinical trial principal investigator, external (and internal) site investigators and staff, and other Washington University team members including those at Trial-CARE, the Center for Clinical Studies, and the Institute for Clinical and Translational Sciences.

Job Description

Primary Duties & Responsibilities

Under general guidance, exercise independent judgment and initiative to perform the following:

• Directs the planning, implementation and coordination of multi-center clinical trials sponsored by industry, government, non-profit foundations, or private organizations.
• Tracks in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, and other study start-up requirements in partnership with the study team.
• Ensures the creation of study documentation (e.g., SOPs, Manual of Study Operations, Case Report Form(s), source documents, surveys, etc.).
• Serves as the established point of contact for the study and study sites; prompts communications to ensure the shortest possible timeframes for start-up and addresses questions from site investigators.
• Assists in budget development.
• Provides oversight and direction to study teams to delegate tasks and to ensure proper conduct in all aspects of a clinical trial which may include management of the Clinical Coordinating Center (CCC), Data Coordinating Center (DCC), and each study site.
• Develops and tracks protocol deviations and develops Corrective and Preventable Action (CAPA) plans and provides consultation and direction to resolve logistical problems associated with the research.
• Submits study protocol, consent form, and any subsequent amendments to the Institutional Review Board (IRB) of record and/or coordinate submission for a Single IRB review model.
• Develops a quality assurance plan and provides ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol.
• Manages the planning and implementation of study meetings.
• Interfaces with the Investigational Drug Service (IDS) to ensure proper distribution of study drug and placebo to each clinical site, if applicable.
• Oversees the development, collection and storage of regulatory documents required in clinical trial, e.g., FDA 1572, IRB approval, etc. Drafts requests and reports to regulatory agencies, e.g., IND application, annual IND update to FDA, etc.
• Oversees the reporting of Serious Adverse Experiences (SAEs), Adverse Events (AEs), other safety information, study suspension, etc.
• Serves as liaison to study sponsors, clinical trial sites, pharmacy department, clinical and research laboratories, contract research organizations, study principal investigators, study medical monitors, biostatistics department, data management unit, and administration/fiscal unit, as needed.
• Possesses extensive working knowledge of Good Clinical Practices (GCP) guidelines and federal regulations (e.g., HIPAA, GDPR, FDA 21 CFR Part 11) applicable to study implementation and data management.

Preferred Qualifications

• Advanced degree in Nursing, Clinical Research Management, or a related field. Research professionals with other backgrounds will also be considered.
• At least five years of experience in clinical research management and supervision of staff.
• Experience working as a lead coordinator or manager on investigator-initiated multi-site clinical trials.
• Experience working as a lead coordinator or manager on drug (IND) and/or device (IDE) clinical trials.
• Effective analytical and problem-solving skills.
• Ability to communicate in oral and written form with all levels of personnel.
• Ability to prioritize tasks in a diverse environment.
• Demonstrated leadership and interpersonal skills.

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, $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.