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DLH Holdings Corp serves federal government clients throughout the United States and abroad, delivering technology-enabled healthcare and public health services, medical logistics, and readiness enhancement services to Military Service Members, Veterans, children and families, and other at-risk and underserved communities. The Company's core competencies include secure data analytics, clinical trials and laboratory services, case management, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has more than 2,000 employees serving numerous government agencies, including Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences. As a market influencer and emerging leader, DLH strives to shape and enhance the "sustainability and readiness posture" of those we serve, delivering value to our customers, stakeholders, and shareholders.
Overview
SSS, a DLH Corporation company, serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company's core competencies include secure data analytics and statistics, clinical trials and laboratory services, a full suite of public health research offerings, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has over 2,000 employees serving numerous government agencies. DLH's portfolio consists of Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences.
We are currently seeking a Study Coordinator to serve on a multi-disciplinary team that conducts, analyzes, and reports on findings from epidemiological and clinical studies on behalf of the federal government. The studies that we conduct focus on autoimmune diseases and environmental exposures. The ideal candidate will have a minimum of five year of experience in clinical research with preference of two years' experience either monitoring and/or in the role of a clinical study coordinator working on FDA/IND trials. The candidate should also be a motivated, detail-oriented individual with excellent communication and organizational skills.
The full-time position will be based onsite in Bethesda, MD at the NIH Clinical Center with tasks assigned by the Project Manager, Study Investigators, and other staff.
Responsibilities
Manage study activities that include, but are not limited to, patient enrollment and scheduling, regulatory submissions, providing laboratory support, timely preparation of adverse event reports, assisting with general study administrative responsibilities, coordinating and performing responsibilities related to research participants, overseeing compliance to protocol and regulatory requirements, and developing and adhering to relevant SOPs.
Essential Functions
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Qualifications
Skills Required
Desired Skills and Experience
Education or Equivalent Experience
Basic Compensation: $70,000- $80,000 yearly
The salary offered within this range will be based on the selected candidates' skills, experience, education, market data, and internal parity. DLH may offer other rewards that may include performance incentives and program-specific awards. An applicant's salary history will not be used to determine compensation.
DLH is committed to fostering a diverse workforce and is proud to be an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
#LI-POST
EEO
DLH Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
DLH Holdings Corp serves federal government clients throughout the United States and abroad, delivering technology-enabled healthcare and public health services, medical logistics, and readiness enhancement services to Military Service Members, Veterans, children and families, and other at-risk and underserved communities. The Company's core competencies include secure data analytics, clinical trials and laboratory services, case management, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has more than 2,000 employees serving numerous government agencies, including Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences. As a market influencer and emerging leader, DLH strives to shape and enhance the "sustainability and readiness posture" of those we serve, delivering value to our customers, stakeholders, and shareholders.
Overview
SSS, a DLH Corporation company, serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company's core competencies include secure data analytics and statistics, clinical trials and laboratory services, a full suite of public health research offerings, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has over 2,000 employees serving numerous government agencies. DLH's portfolio consists of Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences.
We are currently seeking a Study Coordinator to serve on a multi-disciplinary team that conducts, analyzes, and reports on findings from epidemiological and clinical studies on behalf of the federal government. The studies that we conduct focus on autoimmune diseases and environmental exposures. The ideal candidate will have a minimum of five year of experience in clinical research with preference of two years' experience either monitoring and/or in the role of a clinical study coordinator working on FDA/IND trials. The candidate should also be a motivated, detail-oriented individual with excellent communication and organizational skills.
The full-time position will be based onsite in Bethesda, MD at the NIH Clinical Center with tasks assigned by the Project Manager, Study Investigators, and other staff.
Responsibilities
Manage study activities that include, but are not limited to, patient enrollment and scheduling, regulatory submissions, providing laboratory support, timely preparation of adverse event reports, assisting with general study administrative responsibilities, coordinating and performing responsibilities related to research participants, overseeing compliance to protocol and regulatory requirements, and developing and adhering to relevant SOPs.
Essential Functions
- Implement study activities in accordance with NIH and FDA regulations
- Complete patient enrollment activities including recruitment, screening, scheduling, follow-up and payment processing
- Draft and finalize IRB submissions and stipulations including initial and annual reviews, amendments; assembly and mailing of regulatory packages to the FDA
- Create, prepare, and review study forms and complete quality control checks per FDA and NIH guidelines
- Work with Data Managers and Data Team members for forms preparation, and completion of adjudication procedures
- Draft changes to protocol and protocol related study materials as needed
- Liaise with internal and external study team members and collaborators and Study Sponsor(s)
- Develop and maintain study manuals and tracking sheets
- Timely preparation and submission of adverse event and problem reports
- Coordinate and assist with sample delivery and pick-up as needed
- Provide progress and technical reports on a regular basis, and as requested
- Provide other support to cover various study needs as directed
- Coordinate, attend, and, on occasion, lead study-related meetings
- Train study members
- Report to campus at scheduled and ad-hoc times to assist with patient enrollment and study-related needs
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Qualifications
Skills Required
- Ability to plan, prioritize and organize workflow and procedures
- Ability to enter and audit data into web/PC-based software using Windows based applications
- Excellent communication skills
- Ability to multi-task and manage time effectively with minimal supervision
- Ability to write clearly and concisely for regulatory reporting and submissions
- Work independently with minimal supervision
Desired Skills and Experience
- Familiarity with NIH and/or FDA regulations for conducting human subject's research
- Experience with patient interaction, phone screening and scheduling
- Adverse event reporting per clinical standards and FDA requirements
- Strong proficiency with MS Word, Outlook, and Excel; full MS Office experience preferred
- Experience working in a research environment
- Knowledge of medical terminology
Education or Equivalent Experience
- Master's degree or equivalent combination of training and experience in public health, clinical research, nursing, epidemiology, or related field
- 5 or more years supporting clinical trials or clinical research in an applied setting that fosters development of the skills described above
Basic Compensation: $70,000- $80,000 yearly
The salary offered within this range will be based on the selected candidates' skills, experience, education, market data, and internal parity. DLH may offer other rewards that may include performance incentives and program-specific awards. An applicant's salary history will not be used to determine compensation.
DLH is committed to fostering a diverse workforce and is proud to be an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
#LI-POST
EEO
DLH Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
