Senior Clinical Research Program Lead for TB & HIV Trials

Rhode Island Hospital; Rhode Island; On-site; USD 90,000 - 120,000; Full time

Job summary

Rhode Island Hospital seeks an experienced Sr. Clinical Research Program Coordinator to lead study activities and protocol implementation for infectious disease research, including TB, HIV and NTM projects.

You will oversee international and national trials, coordinate sites, ensure regulatory compliance, data quality, and timely achievement of milestones. You will work with a multidisciplinary team, assist with grant preparation, monitor safety, train staff, and maintain study budgets and

Qualifications

• 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)

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.

Skills

Study coordination

Clinical trials management

Education

Bachelor's Degree

Master's degree or equivalent

Nursing degree or equivalent clinical background

Tools

Microsoft Office

Job description

Rhode Island Hospital seeks an experienced Sr. Clinical Research Program Coordinator to lead study activities and protocol implementation for infectious disease research, including TB, HIV and NTM projects.

You will oversee international and national trials, coordinate sites, ensure regulatory compliance, data quality, and timely achievement of milestones. You will work with a multidisciplinary team, assist with grant preparation, monitor safety, train staff, and maintain study budgets and