Reporting to the Site Leader, the Program Manager – Clinical Trials coordinates and monitors all activities related to the National Institute of Health (NIH)/DAIDS clinical trials and COVID grant-funded research conducted through the Harlem Prevention Center (HPC), including study initiation and protocol start up activities, regulatory, recruitment/retention, data management, and quality assurance /quality control activities. Closely collaborate with site and Clinical Trials Unit (CTU) leadership and manages study staff in the implementation of study goals and objectives.
This position is grant funded.
- Recruits and trains study staff on conducting research activities in accordance with study protocols and study specific procedures, standard operating procedures, and other institutional regulations, procedures, and policies. 10%
- Supervises and assists study staff in participant recruitment, retention and enrollment activities including screening of potential volunteers, performing the informed consent process and obtaining a signed informed consent prior to initiating any protocol defined procedures, collection of research data, interviewing and counseling including HIV pre- & post-test counseling, risk reduction counseling and treatment adherence counseling, assist with any appropriate referrals etc.-10%
- Oversees overall day-to-day site activities in compliance with all DAIDS and IRB requirements – 10%
In collaboration with the Site Leader and site Principal Investigators (PIs), develops schedules and complete logistics for the execution of study specific activities. 10%
- Develops and oversees the implementation of an effective and continuous quality improvement plan (CQMP) to ensure the soundness and efficiency of all operational processes related to study activities. 5%
- Review internal and external monitoring reports, data quality reports, data quality management plan and standard operating procedures (SOPs) with the Site Leader and site PIs and the research team and utilizes the findings to develop strategies for improvements. 10%
- Plans and conducts study specific activities in conjunction with other NIH Network sites in an effort to establish economies of scale through enhanced collaboration. 5%
- Ensures timely submission of protocol specific regulatory documents to the CUMC IRB and central IRB(s). The submissions may include initial IRB submission with site specific consent form, amendments, recruitment material, questionnaires, safety reports, protocol renewals/terminations etc. 5%
- Maintains up-to-date federally required essential documents, including CVs, licenses, conflict of interest forms, financial disclosure forms, staff HSP and GCP certifications, staff IATA certifications, laboratory certifications and normal ranges, lab CLIA and CAP certifications etc. 5%
- Ensures timely collection and reporting of research information and data that is legible, accurate, complete, timely, as well as verifiable by internal and external reviewers while ensuring the safety of all study volunteers.5%
- Assists with maintaining track of study specific expenditures and the preparation of timely financial reports. 5%
- Prepares and submits periodic technical progress reports for review by the Site Leader before its release to funding agency as requested. 5%
- Ensures that all team members are notified of all scheduled monitoring visits and audits and takes proactive measures to ensure successful outcomes. 5%
- Participate in research network and study team calls and meetings, as well as CTU meetings.5%
- Perform other duties as assigned. 5%
- Bachelor’s degree or equivalent to education, training and/or experience
- Four years of experience
- 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.
- Demonstrated experience in staff supervision and management
- Master’s degree in public health or other related field
- At least 2 years research experience as a study coordinator of multicenter IND trials
- Holds a CCRC credential from ACRP or CCRP credential from SoCRA or other clinical research certifications accredited by the National Commission for Certifying Agencies (NCCA).
- Experience implementing HIV/AIDS research programs/studies preferred
- An interest in/or experience with COVID related research
- Experience working with an ethnically, culturally, and racially diverse environment
- Local travel required
- Out of town travel to twice yearly research network conferences when restrictions allow (none currently due to COVID)