We are seeking a Clinical Research Coordinator to join our driven research team. This is an amazing opportunity to work with a team that develops and supports an array of outstanding health sciences research programs. As a team you will have the opportunity to foster programs in the areas of basic, translational, mechanistic, and population research.
- Schedule: Hybrid- Monday-Friday
- Pay: $44/hr.
- Terms: 3 month contract with potential for extension or conversion
As a Senior Clinical Research Coordinator, you will be responsible for planning, organization, conducting, and evaluation of multi-faceted clinical research protocols, including study execution, developing strategies and solutions to improve study processes and execution.
Key Duties:
- Proactively recognize areas for study team improvement related to study implementation (e.g., recruitment, retention, study visit flow, etc.), develop and implement solutions.
- Provide coaching in and oversee all areas of clinical research as necessary.
- Assist with the planning and training of junior personnel.
- Provides full supervision to research assistants and student interns, including supervision of the performance review process and disciplinary issues as needed. Set work schedules and approve leave requests.
- Oversee current network of partnering sites.
- Lead site engagement, and lead the identification, selection, and negotiation of additional studies and sites.
- Maintain up to date administrative and regulatory documents (e.g., IRB, CoC).
- Ensure study records and extraction forms are completed in a timely manner.
- Develop and maintain updated and accurate Manuals Of Procedures for studies. (This MOP is the master “directions” for the study, so that anyone could pick up this manual and understand how to conduct the study from beginning to end. MOPs are sometimes provided by companies for industry-sponsored studies.)
- Design methods of successfully operationalizing studies.
- Develop and maintain methods for identifying eligible patients, consenting patients, and performing follow-up assessments.
- Perform reviews of regulatory submissions and materials from study staff; provide correction and feedback as necessary.
- Develop and submit complex regulatory applications and/or study materials (e.g., recruitment materials, informed consent forms).
- Identify, gather, and store required regulatory documentation.
- Prepare for study monitoring, coordinate and participate in monitoring visits, resolve queries and decide corrective action to be taken, as applicable. Convey major points of monitoring reports to the Principal Investigator and supervisory personnel. Track, document, and report protocol deviations and adverse events. Lead the conduct of root cause analyses (RCAs) and development of corrective action plans (CAPAs).
Qualifications:
- Bachelors Degree or Masters Degree in Health Services Research, exercise and sports science, publish health, epidemiology, or a related field
- Experience in human-subjects research is highly preferred
- Experience in MS Office Application & REDCap is highly preferred
- Specialized knowledge in clinical research principles.
- Ability to plan and design methodologies for monitoring data collection.
- Ability to take a leadership role in implementing changes in design of clinical research management.
- Ability to problem solve and resolve quality control issues by changing processes.
