Clinical Research Specialist - Center for Clinical Studies
Washington University in St. Louis
Location: St. Louis, Missouri
Internal Number: JR65724
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 in order to ensure the project proceeds on time and within budget parameters. To accomplish this, the Clinical Research Specialist will collaborate closely with the clinical trial principal investigator, external 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.
Primary Duties and Responsibilities
Under general guidance and with latitude for the exercise of independent judgment and initiative:
Directs the planning, implementation and coordination of multi-center clinical trials sponsored by industry, government, non-profit foundations, or private organizations.
Coordinates the rapid assignment of new study protocols to local implementation experts for review.
Tracks in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, and other study start-up requirements in partnership with study teams.
Creates or assists in creating study documentation (e.g., SOPs, Manual of Study Operations, Case Report Form(s), source documents, surveys etc.).
Prompts communications to ensure the shortest possible timeframes for start-up and addresses questions from site investigators.
Assists in budget development.
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 quality assurance plan and provide ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol.
Oversees the planning and implementation of the Investigatorâ™s/Coordinatorsâ™ meeting.
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.
Reports Serious Adverse Experiences, other safety information, study suspension, etc.
Tracks protocol deviations and develops Corrective Action Plans and tracking.
Provides oversight and direction to study teams to ensure proper conduct in all aspects of a clinical trial being performed at each study site. Provides consultation and direction to study teams to resolve logistical problems associated with the research.
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. Plans internal meetings and provides professional direction within clinical trials coordination team.
Possesses extensive working knowledge of Good Clinical Practices (GCP) guidelines and Regulations applicable to study implementation and data management. Â
Advanced degree in Nursing.Â However, research professionals with other backgrounds will also be considered.
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.
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.
$65,200.00 - $101,100.00 / AnnuallyThe 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.
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.
Washington University in St. Louis is committed to providing a comprehensive and competitive benefits package to our employees. Benefits eligibility is subject to employment status, full-time equivalent (FTE) workload, and weekly standard hours. Please visit our website at https://hr.wustl.edu/benefits/ to view a summary of benefits.
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.
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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Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.