Research Project Coordinator I
2 weeks ago
Overview:
POSITION SUMMARY:
Under the supervision of the Principal Investigator (PI) or their designated representative, the Research Project Coordinator I is tasked with autonomously executing assigned duties and procedures pertaining to human subject research.
This role encompasses the management of regulatory activities and the collection and organization of data for research protocols associated with treatment, ancillary services, and preventive measures.
Our research team engages in a variety of studies aimed at addressing social disparities and enhancing perinatal and pediatric healthcare.We collaborate directly with families facing social disadvantages, including those with limited English proficiency, families from minoritized racial or ethnic backgrounds, and those experiencing low-income challenges.
Our work involves a diverse range of clinical and health services research employing both qualitative and quantitative methodologies. We conduct both observational and interventional studies.We are in search of a Research Project Coordinator I to become a part of our expanding, dedicated research team and to operate under the guidance of the Principal Investigator (PI) or their delegate.
Responsibilities will include a wide array of tasks involving human subject research.This position entails the coordination of regulatory activities and the collection and management of data for research protocols linked to treatment, ancillary services, and preventive strategies.
Our team is looking for a highly driven individual with a keen interest in social determinants of health and a commitment to addressing healthcare disparities.
Responsibilities:
ESSENTIAL FUNCTIONS:
Secure informed consent from research participants from both English and Spanish-speaking families in compliance with IRB-approved protocols and all relevant regulations, including HIPAA.
Identify, schedule, and/or conduct participant study visits, interviews, and assessments.
Coordinate participant compensation in accordance with the protocol.
Maintain all regulatory documentation, including local or central IRB and study data. Provide data and support to study Investigators, sponsors, and/or external monitors/auditors.
Identify and report issues related to protocol compliance. Keep the principal investigator and manager informed of any compliance-related concerns.
Document and gather data and/or samples for research-related procedures conducted during participant study visits.
Ensure that clinicians and/or the PI accurately record their study activities as per the protocol.
Track and maintain study enrollment and the completion of milestones.
Assist with the financial and operational aspects of grants and contracts. May be responsible for reviewing clinical research billing within the required timeframe.
Track and maintain study-related information in the data management system within the required timeframe.
Oversee the inventory of research-related supplies.
Participate in grant preparation, manuscript writing, data presentations, and Institutional Review Board (IRB) processes.
Provide comprehensive written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs.
Present updates on study status related to assigned research projects.
Engage in the design, development, and documentation of study-related data and collection tools, such as questionnaires, treatment data, and/or therapeutic checklists.
Maintain strict adherence to all study protocols, including all regulatory requirements in accordance with federal, local, and institutional guidelines.
Comply with all safety and infection control standards relevant to this position.
Adhere to established policies, health and safety regulations, and requirements, procedures, and departmental objectives.
Follow Good Clinical Practice (GCP) guidelines and all human subject protection practices.
Must exercise discretion and maintain confidentiality in accordance with institutional policies at all times.
Perform additional duties as required.
Qualifications:
REQUIRED QUALIFICATIONS:
Bachelor's degree in a scientific or health-related field, or equivalent experience.
0-1 year of relevant experience.
Ability to travel to off-site locations.
Additional Information:
Fluency in Spanish is preferred.
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