Clinical Research Coordinator Jobs

About
Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.
To us, our work at Truvian is more than a job – It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!
Job Summary
Truvian is looking a Clinical Research Coordinator as we enter the next phase of our evolution. In this role, you will be the operational interface with the patients for our in-house blood donor program as well as other studies where Truvian is participating as a clinical site. You will be responsible for managing the administrative aspects and documentations of on-going clinical studies, in compliance with applicable regulatory standards and Good Clinical Practice (GCP). You will work closely with the Clinical Development and Scientific Affairs (CDSA) Team as well as internal and external stakeholders including regulatory, product development, marketing and scientific affairs to ensure the studies at Truvian are being carried out appropriately and will deliver high quality data as a clinical site to support evidence-based product claims. This role will report to the Sr Manager of Clinical Development and Clinical Affairs.
Here’s Why You’ll Love This Job

• You’ll thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
• You will have a hands-on, operational role to coordinate administrative aspects of on-going clinical studies at Truvian with the aim to generate data that substantiates the performance of Truvian’s breakthrough blood testing technology
• You'll work with a rock star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products
• You’ll be a part of a team responsible for the company’s growth and product launch
• You’ll have great perks such as: Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), paid parental leave, flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on site gym and virtual classes, and a farm to table onsite restaurant including a 30% discount

What You Will Do
Broadly, this role is responsible for the administrative oversight, coordination and documentation of on-going clinical studies to support the delivery of Truvian’s diagnostic products into diverse, global end markets. This will require:

• Assign, label, and distribute requested specimens into the lab space
• Organization of phlebotomy room, monitor decontamination and biohazardous waste disposal.
• Track donor(s) frequency of donation to ensure they do not donate more times as limited by the IRB
• Oversee the execution of clinical in-house studies including recruitment of internal and external donors, data collection and data entry and upkeep of trial master files (TMF)
• Manage phlebotomist scheduling with external vendor
• Order phlebotomy room materials
• For each patient, perform verbal Informed Consent (IC) and maintain most up to date record of ICF (Informed Consent form).
• Maintain working knowledge of multiple Institutional Review Boards (IRB) approved protocols and assist with data entry as needed
• Maintain good record keeping of compensation log per donor and collaborate with Finance team to address pay out concerns
• Monitor multiple draws or failed draws for each draw session
• Work closely with internal cross-functional teams for forecasting sample needs for upcoming week(s)
• Record adverse events for donors experience in draw session
• Maintain up to date documentation including enrollment logs, specimen tracking, compensation logs, etc for each donor
• Manage sign up calendar for available appointments for upcoming studies
• Proactively identify and develop mitigations against anticipated risks and obstacles
• Schedule donors for draw appointments, re-schedule appointments if need arises, perform subject reminder calls
• Record deviations and/or note to files throughout the duration of the internal blood program
• Review and reconcile expense reports for external phlebotomist

What You Will Bring
The ideal candidate will have extensive experience in:

• Partnership and collaboration, ensuring relationships are a forefront of our strategy, emphasizing the company and team over personal goals, and the ability to effectively
• Staying on top of aggressive timelines while actively reviewing participant enrollment budget, through a combination of superior planning and the ability to inspire and enable others to move fast
• Business Tools including experience implementing and working in project planning software, Microsoft office products, Smartsheet, and more
• Problem solving, skills which can be utilized to proactively identify and address issues with a solution-oriented approach with excellent time management skills
• Communicate, both oral and written, with the ability to communicate frequently, clearly, and timely while keeping both internal and external parties aligned to deliver impact at pace
• Clinical Site Management, including implementation of associated processes and documentations

The ideal candidate will be well versed in Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations and HIPAA regulations. They should have a minimum of 3 years of experience in running clinical trials as a clinical research coordinator within the medical device/biotech industry inclusive of conducting participant informed consent. Plus if candidate is a certified Phlebotomist or CNA or a related field with relevant clinical research experience including certification as a Clinical Research Coordinator is desired. Prefer Bachelor’s Degree in life science. The CRC must be able to work as a member of the clinical research team with positive and timely written and verbal communication. This includes communicating protocol deviations or issues with study execution. They are to ensure protocol adherence by understanding, communicating, and making sure the study parameters are ordered and carried out per protocol requirements. The CRC seeks supervision appropriately, prioritizes appropriately, has excellent organizational skills, and completes work in a timely manner and demonstrates accuracy in all details. Finally, the candidate must have the ability to work in a fast paced, start-up environment and manage aggressive timelines.
SUPERVISORY ROLE

• No

SALARY RANGE

• $60,000 to $75,000

This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to, experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on final candidate qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.
Physical Demands And Abilities

• Regularly required to use hands to finger, handle or feel, reach with hands and arms and talk or hear
• Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus
• Frequently required to stand, walk, stoop, kneel, crouch or crawl
• Ability to lift and move over 25 lbs. repeatedly and safely, occasionally 75 lbs. with assistance
• Occasionally required to sit and climb or balance

If you want to stand out, please include a cover letter
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This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.