Clinical Study Coordinator - Medical Device Trial

Job Description

Roam Robotics, Inc. in San Francisco is seeking a detail-oriented and highly organized Clinical Study Coordinator to manage a pilot clinical trial (anticipated 15-18 month duration) with 10-participants for a knee brace that has been shown to reduce pain and increase mobility in a clinical setting. The coordinator will play a crucial role in ensuring the successful execution of the study and adherence to protocols. This is an hourly contract position that would last for the duration of the clinical trial.

• This contract will run for the duration of the study (estimated at 15-18 months) and require approximately 3 days (24 hours) of work/week (workload may vary week-to-week).

• The contract pays in the range of $40/hour to $60/hour based on experience.

• This is an on-site role with a regular presence in our San Francisco facilities, but some tasks may be completed remotely as coordinated with the study PI

• This role may require occasional evening or weekend work to accommodate study needs (i.e., point of contact for study participants)

• Travel may be required for investigator meetings or training sessions

Responsibilities

• Coordinate all aspects of the clinical trial, including participant recruitment, screening, and enrollment

• You will be the first person a participant calls if there’s a question with the protocol, issue with the device, or an adverse event — so availability, a good bedside manner, and ability to solve or flag the issue to the correct place is important

• Manage day-to-day trial activities, including scheduling participant visits and procedures

• Ensure participant compliance with the study protocol

• Collect, enter, and maintain accurate and complete clinical data

• Assist in the preparation and maintenance of study documents

• Coordinate with the participants, research team, sponsors, and clinical collaborators

• Monitor and report adverse events according to protocol guidelines

• Prepare for and participate in monitoring visits and audits

Qualifications

• Minimum of one year of experience in clinical study coordination

• Attention to detail and accuracy in data collection and management

• Strong organizational and time management skills

• Excellent communication and interpersonal skills

• Strong problem-solving skills and adaptability

Desired Skillsets/Experience

• Experience coordinating a clinical study for a medical device

• Experience running usability studies

• Knowledge of impacts of debilitating knee pain on everyday life and mobility or willingness to learn more to understand the user population

• Bachelor's or master’s degree in nursing, life sciences, biomechanics, a related field, or equivalent experience

• Certification as a Clinical Research Coordinator (CCRC)

• Knowledge of FDA regulations, Good Clinical Practice guidelines, and human subject protection

Requirements

• US Citizenship or authorization to work in US

Roam Robotics is committed to equal opportunity employment and values diversity at our company. Roam Robotics provides all employees a work environment free of discrimination and harassment. We do not discriminate on the basis of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Any and all offers of employment extended by Roam Robotics are conditional on candidates’ ability to provide satisfactory proof of eligibility to maintain full-time employment in the United States. At this time, Roam Robotics is unable to provide visa sponsorship and no relocation assistance will be provided.

Because Roam Robotics maintains contracts with the US Military, you may, at a later time, be required to obtain a US Government security clearance as a condition of continued employment. As of this moment, there is no such requirement for any current or future employee.

To apply, send resume and portfolio to candidate@roamrobotics.com