- 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.
- 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.
- 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.
- Medical, Dental, and Vision insurance.
- 401k.
- Sick Time and PTO.
- 10 Paid Holidays.
- Parental and Family Bonding Leave.
- Life, Short Term, and Long Term Disability.
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Clinical Research Coordinator II - Tustin, United States - Tilda Research Inc.
Description
Clinical Research Coordinator II - OnsiteOnsite in Tustin Ca. and Redlands Ca.
Why work at Tilda?
Our MissionTilda 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?We are seeking a highly motivated and detail-oriented Clinical Research Coordinator II to join our dynamic team. As a Clinical Research Coordinator II with us, you will play a vital role in the advancement of medical science and the development of groundbreaking treatments. If you are passionate about advancing medical knowledge, dedicated to the highest standards of research, and possess the attributes we value, we invite you to apply for the position of Clinical Research Coordinator II. Join us in our mission to make a lasting impact on healthcare and contribute to a brighter, healthier future for all.
Duties and Responsibilities:
The above reflects the general duties considered necessary to describe the principal functions of the job as identified and shall not be considered a detailed description of all the work requirements which may be inherent in the position.
Required Skills and Abilities:
Education and Experience:
Benefits include but are not limited to:
$56k - $83k per yr.