Study Coordinator(COVID grant funded research)
To assist the Site PI in the implementation of COVID clinical trials at Harlem Hospital and in oversight of day-to-day research activities.
Under the supervision of the Site PI, the Study Coordinator will collaborate and oversee all activities related to COVID grant-funded clinical trials research conducted at NYC H+H/Harlem, including site initiation and protocol start-up activities, assisting regulatory coordinator with regulatory requirements, recruitment and retention plans and study implementation, data management, and quality assurance and control activities. The Study Coordinator will work closely with the Site Principal Investigator and research staff in the implementation of study goals and objectives.
DUTIES & RESPONSIBILITIES:
1. Complete Good Clinical Practice and Human Subject Protection trainings and abide by those research practices and standards.
2. Attend study specific and other study related trainings and meetings as requested by the Study PI.
3. Conduct all research activities in accordance with study protocol, standard operating procedures and other appropriate institutional regulations, procedures, and policies, including procedures to safeguard confidentiality of study participants. Develop standard operating procedures for COVID clinical trials
4. Coordinate study visits, study evaluations and procedures including the laboratory and pharmacy components of the protocol.
5. Provide education to participants related to the study protocol, including a careful review of all study drugs, and reporting any adverse events.
6. Prepare site for activation including set-up of research office, office systems and SOPs, etc.
7. Oversee study staff on day to day activities of study implementation and administration. Participate in study implementation activities such as consenting participants, participant follow-up, and QA/QC activities at the site.
8. In collaboration with the site investigator and regulatory coordinator, ensure timely submission of protocol specific regulatory documents to the central IRB. Assist regulatory coordinator in maintaining study regulatory files and communicate with the relevant IRBs for timely submissions and to ensure essential documents and regulatory documents are up to date.
9. In collaboration with the data study team, ensure timely collection and reporting of research information and that data is verifiable by internal and external reviewers.
10. Maintain confidentiality of study participants and adhere to principles of Good Clinical Practice (GCP) and ethics of human subject research
11. Attend staff meetings, study specific and other study related trainings as requested by the sponsor and site Principal Investigator.
12. Perform other duties as assigned.
EXPERIENCE, SKILLS & MINIMUM REQUIRED QUALIFICATIONS
* Knowledge of research data management and regulatory compliance.
* Excellent clinical, organizational, interpersonal and communication skills.
* Must be able to adapt to flexible schedule.
* Proficiency in computer applications.
* Meticulous attention to detail with the ability to multi-task.
* Ability to work under pressure and react effectively to urgent situations.
* Ability to work independently and as part of a team.
EXPERIENCE, SKILLS & PREFERRED QUALIFICATIONS
* An interest in/or experience with COVID related research
* Experience working with an ethnically, culturally, and racially diverse environment
* Phlebotomy skills
* Master's degree in Public Health or related clinical field
*At least 2 years research experience as a study coordinator in a clinical trial.
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