Clinical Research Coordinator II

4 weeks ago

Tustin, United States CareerBuilder Full time

Why work at Tilda?
Our Mission
Tilda exists to accelerate the development of new medical treatments by providing every person easy access to clinical trials. As a tech-enabled clinical trial network, we build software and services to help pharma innovators better execute their clinical trial programs. Our work leads to faster cures and thus institutes a meaningful impact on millions of lives. You can help us realize that goal.
Who are we?
Tilda Research is an innovator in clinical research recruitment and trial execution. We operate a growing network of clinical research sites in the US, and our team has worked on over 250 pan-indication Phase I thru IV studies. Our founders are successful serial entrepreneurs, with three of their past companies leading to IPOs (VMware, MobileIron) or exits (LexentBio acquired by Roche). We also build software and support clinical trial infrastructure to help pharmaceutical companies identify, enroll, and execute clinical trials efficiently.
Who are you?
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI) and Sub-Investigator (SI). The CRC supports, facilitates and

coordinates

the daily clinical trial activities and plays a critical role in the conduct of the study by working with the PI, SI, department, sponsor, and company.
Work Locations: Tustin & Redlands CA.
Duties and Responsibilities:

Organize and conduct clinical studies using good clinical practices (GCPs).
Recruit and consent appropriate patients into assigned projects.
Coordinate patient communications and appointments as needed.
Provide relevant study feedback to assist in modifying recruitment/enrollment filters and sourcing available subjects.
Ensure protocol adherence and accuracy of research data and transcription into data capture systems where appropriate.
Meet chart review, screening, and enrollment quotas within defined timelines.
Upload documents such as labs, other clinical documents, and informed consent documents into established clinical trial management systems and/or electronic trial master file.
Complete data entry (eSource) on time and according to ALCOA-C principles to ensure rapid data entry by the remote data team.
Proficiency with capturing ECGs and reporting relevant findings to the clinician on staff based upon available interpretation.
Proficiency with collecting vital signs and reporting irregularities to the clinician on staff.
Proficiency with laboratory collection (phlebotomy) along with processing according to available laboratory manuals.
Proficiency with basic regulatory filing and IRB communication.
Work with remote data entry teams on complex query resolution and preparation/completion of interim monitoring visits.
Queries to be addressed appropriately within defined timelines per study protocol.
Completion of findings reported during monitoring visits in a reasonable manner.
Work with shared services where appropriate for items such as regulatory, data entry, finance, etc.
Hosting of client audits for specific studies.
Perform other duties as assigned.
Required Skills and Abilities:

Ability to work as a team (collaboration with internal and external departments required).
Spanish Speaking / Bilingual preferred, not required.
Excellent interpersonal and communication skills.
Excellent critical thinking and problem-solving skills.
Ability to function well in a fast-paced environment and ability to self-motivate.
Excellent organizational skills and attention to detail.
Reliable transportation is required.
Travel may be required to multiple sites in Southern California.
Education and Experience:

Bachelor's Degree OR equivalent experience in a clinical research setting without a degree.
A minimum of 2 years experience in a clinical research setting.
Blood Draw experience and ECG experience are required.
Phlebotomy Certification Preferred.
Benefits to include but are not limited to:

Medical, Dental, and Vision insurance
401k
Sick Time and PTO
10 Paid Holidays
Parental and Family Bonding Leave
Life Insurance, Short Term and Long Term Disability
$30 - $40 an hour
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