Job Details

Overview

The Work:

The Study Coordinator II provides advanced coordination and operational support for government?led clinical and translational research studies. Working under the direction of the Principal Investigator (PI) and/or designated government point of contact (POC), this position is responsible for the day?to?day execution of study activities, including subject screening, enrollment, and monitoring; collection and management of clinical and research data; and coordination of biospecimen collection for laboratory analysis. The Study Coordinator II ensures that all study procedures are conducted in accordance with approved protocols, regulatory and ethical requirements, and institutional policies, and contributes to data analysis and the preparation of written reports and summaries of study findings.

This position aligns with Cayuse's core values of Innovation, Excellence, Collaboration, Adaptability, and Integrity by fostering technical solutions that meet customer needs, promoting teamwork, and prioritizing quality in deliverables.

Responsibilities

Key Responsibilities:

• Identify potential clinical and translational research studies and assess the suitability of the TAMC patient population based on protocol?specified inclusion and exclusion criteria, anticipated enrollment needs, and required timelines for study completion.
• Align sponsored studies with an appropriate Principal Investigator (PI), taking into account clinical specialty, research interests, and operational feasibility, and coordinate initial study start?up discussions as needed.
• Advise and support the PI with respect to Scientific Review Committee and Institutional Review Board (IRB) requirements, including preparation and submission of protocol materials, amendments, and continuing reviews, and coordinate interactions with clinical collaborators, sponsors, and other external partners.
• Recommend, help assemble, and coordinate clinical and translational study teams-including study coordinators and other required personnel-to support effective execution, monitoring, and close?out of assigned studies.
• Collect, organize, maintain, and securely manage study data and documentation; administer day?to?day project activities; and assist with drafting reports, abstracts, and manuscripts derived from study findings.
• Review patient records to identify and pre?screen potentially eligible subjects, provide input on enrollment strategies, and coordinate or perform study subject enrollment activities, including collection of required clinical specimens for laboratory analysis in accordance with protocol requirements.
• Collaborate with internal departments across TAMC (e.g., Pharmacy, Laboratory, Radiology, Nursing) to support implementation of clinical and translational studies. For prospective clinical trials, oversee or coordinate the informed consent process, monitor and document patient response to therapy, and ensure that all adverse events and protocol deviations are promptly noted, cataloged, and reported per regulatory and sponsor requirements. For translational laboratory or animal model studies, coordinate and perform specimen collection, processing, and documentation.
• Track study subject course and status throughout participation; interface regularly with physicians, nurses, and technicians to obtain current clinical information; and ensure that all case report forms and other required study documentation are completed accurately, contemporaneously, and in accordance with sponsor and regulatory requirements.
• Retrieve relevant data from patients' written and electronic medical records and other institutional systems (e.g., imaging, laboratory, and culture result databases), abstract necessary information, and accurately enter these data into case report forms, databases, or electronic data capture systems.
• Maintain strict confidentiality and secure handling of all study logs, source documents, and collected patient data in accordance with HIPAA, institutional policies, and protocol?specific confidentiality requirements.
• Prepare written analytic reports that summarize study data, including a description of statistical methods used, evaluation of statistical limitations, and discussion of potential interpretations of the findings. Prepare and submit additional study documentation as required, including progress reports, protocol deviation reports, continuing review submissions, and updates to protocol approval documents.
• Perform timely data analysis for electronic data sets, providing requested analyses within one week of receipt when data are provided in electronic spreadsheet format; when data are provided only in hard copy, complete data entry into an electronic spreadsheet within one additional week and thereafter provide analyses within the established timelines.
• Other duties as assigned.

Qualifications

Qualifications - Here's What You Need:

• Bachelor of Science degree in a biomedical science discipline or in nursing is required.
• Minimum of six (6) years of experience in clinical or translational research, or documented successful execution of more than thirty (30) clinical trial studies and/or collaborative biomedical laboratory studies at a Study Coordinator II level.
• Demonstrated experience in research regulatory compliance, including preparation and management of Institutional Review Board (IRB) submissions and approvals; implementation of Human Research Protection Plan (HRPP) requirements; interaction with Data and Safety Monitoring Boards (DSMBs); and support of Quality Assurance (QA) activities related to research conduct and execution.
• Resume or curriculum vitae must demonstrate experience conducting clinical and translational research studies, including chart review, specimen collection and processing, data management, and effective interaction with physicians, scientists, nurses, and other clinical and laboratory personnel.
• Must be able to pass a background check. May require additional background checks as required by projects and/or clients at any time during employment.

Minimum Skills Required:

• Proven ability to analyze quantitative and qualitative data, interpret results, and succinctly summarize findings for inclusion in technical reports, presentations, and publications.
• Demonstrated capability to prepare and deliver high?quality oral and written scientific presentations-as evidenced by peer?reviewed publications, abstracts, posters or podium presentations at regional/national conferences, invited lectures, scientific presentations, or thesis/dissertation work-based on data analysis and study results.
• Documented history of managing multiple concurrent clinical and translational research studies or clinical trials, including development and implementation of policies, standard operating procedures (SOPs), and processes to support effective study execution, oversight, and compliance.
• Proficiency with computer applications, including Microsoft Word and Excel; ability to retrieve and abstract information from electronic medical records and other computerized data systems; and experience developing tracking tools and maintaining accurate, organized data and research records.
• Familiarity with basic statistical principles and methods, as well as experience contributing to or preparing manuscripts for submission to peer?reviewed journals.

Desired Qualifications:

• Preferred experience overseeing investigator?initiated, industry?sponsored, and/or military?funded clinical or translational research studies.
• Preferred more than five (5) years of experience in coordinating collaborative research partnerships, establishing and maintaining networks of clinical and laboratory investigators, leading project management activities, and supporting or conducting laboratory analyses.
• Preferred post?baccalaureate degree in a biomedical or health?related discipline (e.g., M.D., Ph.D., or master's degree in biomedical sciences or a health care profession) with demonstrated clinical or translational study experience.

Our Commitment to you / overview of benefits

• Medical, Dental and Vision Insurance; Wellness Program
• Flexible Spending Accounts (Healthcare, Dependent Care, Commuter)
• Short-Term and Long-Term Disability options
• Basic Life and AD&D Insurance (Company Provided)
• Voluntary Life and AD&D options
• 401(k) Retirement Savings Plan with matching after one year
• Paid Time Off

Reports to: Program Manager

Working Conditions:

• Professional office environment.
• Work is primarily performed in a clinical, office, and research environment within a military medical treatment facility and associated laboratories.
• Must be physically and mentally able to perform duties extended periods of time.
• Ability to use a computer and other office productivity tools with sufficient speed to meet the demands of this position.
• Must be able to establish a productive and professional workspace.
• Must be able to sit for long periods of time looking at computer screen.
• May be asked to work a flexible schedule which may include holidays.
• May be asked to travel for business or professional development purposes.
• May be asked to work hours outside of normal business hours.

Other Duties: Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Cayuse is an Equal Opportunity Employer. All employment decisions are based on merit, qualifications, skills, and abilities. All qualified applicants will receive consideration for employment in accordance with any applicable federal, state, or local law.

Pay Range

USD $75,000.00 - USD $82,000.00 /Yr.