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Clinical Research Specialist II
2 months ago
Overview:
POSITION SUMMARY:
The research division is engaged in a variety of investigations aimed at tackling social inequalities and enhancing perinatal and pediatric healthcare.
Our work involves direct interaction with families facing social challenges, including those with limited English proficiency, families from underrepresented racial and ethnic backgrounds, and low-income households.
We conduct diverse clinical and health services research employing both qualitative and quantitative methodologies. Our studies encompass both observational and interventional approaches.We are in search of a Clinical Research Specialist II to contribute to our dynamic and dedicated research group, working under the guidance of the Principal Investigator (PI) or their delegate.
Responsibilities will encompass a wide range of activities related to human subject research.This role includes the coordination of regulatory functions and the management of data collection for research protocols pertaining to treatment, ancillary services, and preventive strategies.
We are looking for a driven individual who is passionate about social determinants of health and committed to addressing healthcare disparities.
Responsibilities:
ESSENTIAL FUNCTIONS:
- Secure informed consent from research participants from English- and Spanish-speaking families in accordance with approved protocols and relevant regulations, including HIPAA.
- Assist in the recruitment, screening, enrollment, and withdrawal of study participants.
- Ensure the accuracy and completeness of all regulatory documentation, including local or central IRB submissions and study data.
- Facilitate communication with multidisciplinary clinical and research team members, both internally and with external collaborators.
- Document and gather data and/or samples for research-related procedures conducted during participant visits, including qualitative interviews.
- Perform preliminary quality assurance assessments of study data.
- Support financial and operational components of grants and contracts, which may include clinical research billing review within specified timelines.
- Present updates on study progress related to assigned research projects and assist in drafting annual reports for NIH.
- Contribute to data presentations and Institutional Review Board (IRB) processes, including multicenter reliance agreements.
- Maintain and track study-related information in the data management system within required timelines. Provide comprehensive written summaries from literature reviews and related sources to support the study team and clinicians/PIs.
- Aid in the design, development, and documentation of study-related data collection tools, such as questionnaires, treatment data, and therapeutic checklists, including electronic surveys and randomization modules.
- Translate study documents as necessary.
- Monitor the inventory of research-related supplies.
- Document and collect data/samples for research-related procedures performed during participant visits, ensuring accurate documentation by clinicians and/or the PI according to protocol.
- Ensure strict adherence to all study protocols, including regulatory requirements, while identifying and resolving compliance issues. Keep the principal investigator and manager informed of any compliance-related concerns.
- Comply with all safety and infection control standards relevant to this position.
- Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection protocols. Perform additional duties as required.
Qualifications:
REQUIRED QUALIFICATIONS:
- Bachelor's degree in a scientific or health-related discipline, or equivalent experience.
- 1-3 years of relevant experience.
- Willingness to travel to off-site locations.
- Strong communication skills and cultural competence.
- Experience with qualitative interviewing is preferred, but not mandatory.
Additional Information:
- Fluency in Spanish is preferred.
