Sr Clinical Research Prgm Coord

SUMMARY

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.

This will involve oversight of all aspects of implementation of international research projects, including assisting with development of trial protocols, design of case report forms, working with a data manager to capture high-quality data, working with international sites to coordinate site activation and activities, planning and facilitating multi-party meetings, and preparing regulatory filings. Local trials work will be a smaller component of the role and may include recruitment, completing case report forms, submitting forms to the sponsor, working with a data manager, responding to sponsor queries, conducting patient visits, ensuring protocols are followed, and interacting with the pharmacies for study medications.

Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.
In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:
Instill Trust and Value Differences
Patient and Community Focus and Collaborate

• 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.
• Prociently 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 eective screening and recruitment strategies and completing required documentation.
  • Provides education and training to appropriate personnel and participants in research specic 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, clinical trials.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.

The responsibilities listed are a general overview of the position and additional duties may be assigned.

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…