Senior Clinical Research Coordinator
2 weeks ago
We are looking for a Senior Clinical Research Coordinator to oversee and manage both multi-center and single-center clinical research initiatives funded by federal and industry sources. This role is crucial for studies conducted in intensive care and post-intensive care environments within the Division of Pulmonary and Critical Care Medicine.
Key Responsibilities:
The coordinator will be responsible for:
1. Acting as the main liaison between the Principal Investigator (PI), research personnel, and administrative offices.
2. Facilitating effective communication among all parties involved in the research project.
3. Streamlining administrative processes to enhance the execution of contracts and protocol approvals.
4. Organizing and coordinating meetings with investigators and data management teams.
Research Management:
The coordinator will maintain a comprehensive understanding of assigned protocols and will:
1. Develop materials to assist research staff in adhering to protocol requirements.
2. Oversee the recruitment, screening, and enrollment of suitable participants for clinical trials.
3. Manage regulatory documentation, including maintaining accurate regulatory binders and spreadsheets.
Data Collection and Reporting:
Responsibilities include:
1. Preparing and submitting necessary reports to the Institutional Review Board (IRB) and Data Safety Monitoring Board (DSMB).
2. Ensuring the accuracy and timeliness of data entry and management.
3. Monitoring compliance with data quality assurance and control standards.
Collaboration and Compliance:
The coordinator will:
1. Work closely with the PI and other team members to ensure adherence to study protocols.
2. Participate in study initiation and monitoring meetings, addressing any discrepancies in data.
3. Prepare regulatory documents in accordance with federal and institutional guidelines.
Qualifications:
1. A Bachelor's Degree in a relevant field is required; a Master's Degree is preferred.
2. A minimum of three years of related experience is necessary, with additional education potentially substituting for experience.
3. Strong organizational, communication, and interpersonal skills are essential.
Physical Requirements:
1. Ability to sit for extended periods and perform tasks requiring finger dexterity.
2. Capability to lift up to 40 lbs.
Work Environment:
This position is based within the School of Medicine, contributing to a collaborative and inclusive workplace culture.
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