Sr Clinical Research Prgm Coord 2

About the role

Experienced Sr. Clinical Research Program Coordinator to help lead a research program and study-related activities and protocol implementation for local, national, and international research studies in tuberculosis, HIV, and non-tuberculous mycobacteria (NTM). The Sr. Clinical Research Program Coordinator works collaboratively with the entire study team to manage workflow and monitor outcomes, ensuring productivity and timely attainment of project goals. The overall focus of these studies is development and evaluation of new treatments for these infectious diseases, through work that includes clinical trials.

Responsibilities

• Possesses knowledge and understanding of policies, procedures, and regulations governing human subject research and incorporation of them in the conduct of research and care of participants.
• Proficiently prepares and processes new research proposals, amendments, continuing review applications, adverse events, budgets, and accounts.
• Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards.
• Independently leads implementation of multiple research studies:
• For local clinical research studies:
• Leads team in the completion of all research protocols, and delivers goal focused, individualized, safe, care as it relates to research participants.
• Participates in the recruitment of eligible candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
• Provides education and training to appropriate personnel and participants in research specific methodology and procedures.
• Utilizes knowledge of disease processes to observe for and report adverse events to the Principal Investigator and all regulatory authorities as required by protocol, policies and procedures and regulations.
• For national and international studies:
• Proactively communicates regarding study progress with the PI and collaborators.
• Assists with grant preparation: tracking documents and grant sections. May write components of grants, assisting with budgets and budget justifications, and literature searches.
• May participate in study design and data collection.
• Coordinates study calls and meetings and maintains minutes.
• Contributes to study protocol development. Participates in data tool development.
• Participates in regulatory submissions (e.g., IRB, clinicaltrials.gov) and keeping regulatory approvals up to date. Prepares all documents related to the informed consent process.
• Assists in submission of closeout documents to applicable federal agencies, university entities, and the sponsoring agency.
• Coordinates meetings and other communications between international partners and study investigators.
• Conducts routine data quality checks and manages queries of study data.
• Contributes to writing of manuscripts.
• Prepares updates for study site partners including health facilities and TB program leadership. Prepares other dissemination products as needed.

Requirements

• Bachelor’s Degree in related discipline required.
• Master’s degree or equivalent experience in a related field preferred.
• Nursing degree or equivalent clinical background preferred.
• Minimum three years experience in study coordination, including the conduct of clinical trials.
• Experience in program coordination highly preferred.
• Strong background in managing large-scale research programs and collaborating with faculty, staff, and external stakeholders.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Access) and experience with research-related software and databases.
• Ability to use analysis applications including (e.g., STATA) is preferred but not required.
• Excellent problem-solving, planning, and organizational skills, with experience managing multiple projects and priorities in a fast-paced environment.
• Strong interpersonal and leadership skills, with the ability to communicate effectively, both orally and in writing, and work collaboratively with diverse teams.
• Experience working with Institutional Review Boards (IRB) and research compliance.
• Meticulous attention to detail required.

Work Environment

The position is primarily office-based but requires some physical activity, including walking, standing, and navigating stairs. Must have ability to travel to study sites, including internationally, and to perform virtual study monitoring visits. While most duties are performed in an office environment, risk of exposure to contagious or noxious elements is minimized by adherence to safety procedures and protocols.

Independent Action

Demonstrated ability to function autonomously and independently while maintaining a team-oriented approach to leadership of research program and study teams.

Supervisory Responsibility And Team Collaboration

Directly supervises up to 5 administrative and research staff members ensuring their professional growth and ensuring smooth coordination of daily operational tasks and indirectly oversees the activities of 10–30 faculty, staff, and trainees, depending on the size and scope of research program and active projects at any given time.

Pay Range

$64,480.00–$106,412.80