Under the direction of the Operations Director for Network Trials, the Study Coordinator works with other staff in supporting the implementation of clinical trials according to specified study protocols.
- Coordinates Research Projects and Conducts Study Visits
- Oversees day-to-day operations of assigned study protocols, including conducting study visits, collecting data, facilitating required safety reporting, and completing Case Report Forms (CRFs) and data entry
- Supports start-up activities of new studies
- Revises protocol questionnaires, consent forms, and other study related documents as needed throughout the course of research studies.
- Maintains and files Safety Reports
- Meets regularly with the research team to review adherence to the project design, conduct of the project, resources and staffing, and the fidelity and quality assurance of the interventions
- Troubleshoots research issues, interfaces with and solves problems raised by sponsors, funders, collaborators and staff
- Communicates with study Investigators, sponsors, external collaborators, recruitment and study staff.
- Represents the site on national conference calls and at national meetings.
- Supports development and maintenance of Standard Operating Procedures (SOPs) for consistent operations in compliance with protocol guidelines
- Ensures protocol(s) compliance with quality management plan
- Provides timely reports to study staff, administrators and investigators regarding suggested remedies and training needs.
- Ensures specimen processing, storage, database entry, and shipment procedures are conducted per protocol
- Creates and outlines visit flow and responsibilities for all study staff
- Conducts training for study team members.
- Schedules site monitoring visits; provides assistance to monitors during on-site visits; communicates pre-and post-visit regarding study conduct and sponsor expectations.
2. Oversees Data Collection and Dissemination
- Reviews project-specific systems and designs, and implements new systems to ensure and enhance project efficiency
- Performs quality control on data collection systems to assure and maintain the quality of all written and computerized data
- Creates and supervises the implementation of subject recruitment and retention documentation, specimen collection and data collection tools.
3. Manages the Recruitment and Screening of Study Volunteers
- Works with recruiters and staff to participate in the recruitment of study participants for specified research studies.
- Collaborates with the recruitment team to identify creative measures for reaching potential study participants.
- Assists with telephone screening and scheduling of study participants.
- Reviews, discusses, and completes informed consent with clients.
- Delivers presentations to community members regarding research studies.
4., Meets Agency Participatory Expectation
- Adheres to all agency and departmental policies and procedures.
- Adheres to the highest principles of patient and client confidentiality.
- Adheres to established safety policies, procedures and precautions; identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation.
- Attends all required meetings, in-services, and professional trainings.
- Maintains professional competence necessary to perform job responsibilities; seeks training and development opportunities within and outside of the organization to increase knowledge.
- Serves on agency committees and in professional organizations when requested.
We offer competitive salaries, and for those who qualify, an excellent benefits package; including comprehensive medical and dental insurance plans, and a retirement plan with employer match. We also provide 12 paid holidays, paid vacation, and more.
LGBTQIA+ identified persons, people of color, and others from historically underrepresented communities are encouraged to apply.
- Familiarity working with underserved populations, particularly LGBTQIA+ and people living with HIV or at risk for HIV
- Attentive to detail.
- Ability to function autonomously in a collaborative interdisciplinary team.
- Excellent communication and interpersonal skills.
- Ability to work in a fast paced and changing environment.
- Manages stress effectively.
- Capacity for detail and multitasking.
- Strong problem-solving skills.
- Experience working in an ethnically, culturally, and racially diverse environment.
- Able to execute study visits without direct supervision.
- Team player, aware of the needs of the group.
- Receptive to training and feedback.
- Critical thinker – able to anticipate shortfalls and plan ahead.
- Phlebotomy experience desirable
Provides supervision to staff members as assigned.