Clinical Research Coordinator I (CRC-I)
You: experienced, smart, flexible, hard-working, and take initiative.
Otolith: startup, fast-paced, focused, collaborative, supportive.
We are looking to hire a clinical coordinator who may have experience obtaining informed consent, conducting study participant meetings, completing study documents, communicating effectively with study participants online, and adhering to a quality system framework. This role reports to the Otolith Clinical Research Team Lead and/or Manager. Prior experience working with patients is recommended.
If you have some experience participating in or observing clinical research, this is a great opportunity to gain clinical professional experience and work at a company that values contribution and dedication.
As a Clinical Research Coordinator I, you will be responsible for a wide variety of clinical trial activities. On a day-to-day basis, you will be involved with the study participants from enrollment to study wrap-up. In the big picture, you will be involved in all aspects of the company’s clinical research. You will provide input to help shape the design of the studies based on your interactions with the study participants. You will be a key member of the team that is taking this new device from research to FDA approval and onto the market. You will look for ways to make our clinical studies more efficient and effective without compromising the quality, safety or results of the study by using new technologies, social networks, and a can-do spirit.
About Otolith Labs
Otolith Labs is a startup company based in Washington, DC, developing a novel medical device to treat vertigo, a problem that affects millions of people annually. Our device has received Breakthrough Device Designation from the FDA and we are conducting a pivotal trial to demonstrate the efficacy and safety of our device. Some of our trials use a tele-health model with remote monitoring of study participants.
RESPONSIBILITIES:
Specific responsibilities include, but are not limited to:
- Conduct and schedule online meetings with study participants while following their progress throughout the study
- Ensure participants are completing their study activities according to the protocol
- Collect and submit Adverse Event and Protocol Deviation reports to our principal investigator
- Share insights with other members of the clinical team to shape the design and conduct of future studies
- Receive in-person training on our current ongoing study, which includes shadowing online meetings
- You will quickly progress to taking the lead in these meetings and then conducting them autonomously
- You will send a daily study update to the Manager of Clinical Research
- Embrace a Quality Management System and mindset
- Other responsibilities as assigned
Since you are on the front line with the study participants, your suggestions and guidance will shape the development of new protocols, informed consent forms (ICFs), case report forms (CRFs), budgets, and study plans. We want you to speak up and contribute everyday in all aspects of clinical research.
REQUIREMENTS:BS, BA in Life Sciences or related field.
Capable of working in a fast-paced environment and taking initiative in seeking and utilizing available resources to solve problems, all while ensuring the clinical trial is executed within compliance of regulations and of the highest quality
Proactive in identifying areas of improvement to drive efficiency within Clinical Operations
Knowledge of multiple aspects of the clinical research discipline and good clinical practices.
RECOMMENDED:
Knowledge of informed consent process and good clinical practices
Working knowledge of electronic data capture (EDC) systems and/ electronic health record (EHR) systems
BENEFITS:Stock Options401KHealth InsuranceFlexible vacation policy
Job Type: Full-time, exempt
Salary: $64,000 - $68,000 per year based on education, experience and training
Schedule: Monday to Friday
Education: Bachelor's
Experience: Clinical Trials: 1 year (Preferred)
Work Location: Washington, DC
Work Remotely: Remote with the ability to meet at the office as needed (1-2 times a month)
CONTACT:
To apply, please email your resume and cover letter detailing your relevant experience and professional goals to Alesia Robinson.
Job Type: Full-time
Pay: $64,311.00 - $67,317.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Professional development assistance
- Vision insurance
Experience level:
Medical specialties:
Schedule:
Ability to Commute:
- Washington, DC 20001 (Required)
Work Location: Hybrid remote in Washington, DC 20001