TIME Clinical Research Coordinator (Bethesda, Maryland)
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
- Educate and provide updates to providers and research staff regarding available TIME Trials and enrollment status
- Manage rapid study activations for just-in-time trials and oversee activities including but not limited to: collect and submit documents needed to initiate the study, prepare IRB submission, schedule SIV, organize and work with necessary hospital staff to complete all study related training
- Recruit and screen potential study participants and perform intake assessments for assigned trials
- Coordinate all study visits and assist PI with completion of trial activities including but not limited to: schedule participant visits, coordinate participant travel and meals, participant dosing and observation, scheduling and other evaluations, AE monitoring, vitals collection, and IVRS management
- Manage the inventory of equipment and supplies related to assigned trials
- Collect, process, and ship specimens
- Input data and patient information into electronic systems
- Ensure compliance with research protocols by providing ongoing quality control audits
- Collaborate with the research pharmacist to perform drug accountability, compliance and dosing
- Create and maintain study files including regulatory binders, source documentation and other materials
- Professional communication with sponsors, representatives and other study related parties
- Schedule and handle monitoring visits and/or trial audits, including but not limited to: coordinate with CRO/monitor, schedule time for the CRO/monitor to meet with PI, pharmacist, and other applicable staff, respond to data queries, document deviations with CRO and CIRB as applicable
- Participate in molecular tumor boards and/or regular physician meetings to review patient cases related to TIME Trials
- Other duties as assigned
- Candidate must have a Bachelor’s degree in science or health related field
- 2+ years of work as a clinical research coordinator in an oncology setting
- CCRC preferable
- Strong planning and project management skills, with the ability to set goals and prioritize/manage multiple projects and tasks.
- Excellent organization and communication skills with high attention to detail.
- Knowledge of current FDA regulations, and Good Clinical Practices (GCP's) governing clinical research and HIPAA
- Proficient in the use of MS Office applications (Outlook, Word, Excel, PowerPoint).
- Understanding of study start up and trial activation
Typical working conditions:
- Typically sitting for long periods of time; also stooping, bending and stretching for files and supplies.
- Occasional lifting of up to 50 pounds.
- Requires manual dexterity sufficient to operate a keyboard, type at 60 wpm, operate a calculator, telephone, copier, and other office equipment as necessary.
- Vision must be correctable to 20/20 and hearing must be in the normal range for telephone contacts.
- It is necessary to view and type on computer screens for long periods and to work in an environment which can be stressful due to heavy workload and frequent interruptions.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.