Research Program Coordinator
Bowie, MDFull-time
Behavioral Health Market Context
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Benefits
Growth: Opportunities for professional development, including tuition reimbursement and developing foundational skills for neonatal critical care leadership and advanced certificationSupport: A culture of collaboration with resources like unit-based practice councils and advanced clinical education support — improving both workflow efficiency and patient outcomes and allowing you to work at the top of your licenseBenefits: Competitive compensation (additional compensation such as overtime, shift differentials, premium pay, and bonuses may apply depending on job), comprehensive health plans, free parking, and wellness programs
Qualifications
- •Basic professional knowledge; working knowledge of theory and practice within a specialized field
- •Health Science/Public Health or related field
- •Experience: 1-3 years related exp
Responsibilities
- •Prepares regulatory documents and monitors regulatory activities for assigned clinical trials
- •Prepares protocol for initial and annual IRB (Institutional Review Board); submits protocol revisions and amendments for IRB review; submits Serious Adverse Events reports and Investigational Drug Safety Reports to the IRB; maintains IRB correspondence documentation for study sponsor and cooperative group audits
- •Prepares regulatory documentation binders for study monitoring and audits by National Cooperative Groups (NCG)/Pharmaceutical companies/FDA; assists in preparation of patient charts for audits and monitoring visits
- •Prepares initial Informed Patient Consent forms for study participation; prepares form revisions when requested by study sponsor and submits for IRB review
- •Manages the day to day regulatory/protocol maintenance operations of the assigned clinical trials
- •Assists with the implementation of the clinical research agreement, study budget and investigator contract, review and submission; responsible for annual protocol/research agreement renewal coordination
- •Assists physicians with obtaining protocols of interest; prepares and submits site assessment documentation and regulatory package to study sponsors; coordinates and facilitates pre-study, study initiation and study monitoring visits
- •Develops data collection system to provide necessary patient and physician communication, report generation and statistical output; manages and augments system as necessary; inputs information into the database and verifies accuracy
- •Assists Clinical Research Nurses with patient data collection and submits research data to the NCG according to the protocol regulations; assures compliance with standards set by research groups for continued participation
- •6 more items(s)
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