Manager Clinical Research Informatics Jobs in Berkeley, CA

Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Shift: Full time, Monday-Friday, 8:30 - 5 PM (flexibility needed depending on patient schedules)
Location: Walnut Creek, CA
Compensation: $24-$33 per hour
RESPONSIBILITIES

• Execute protocol-specified patient visits and procedures, which may include, but not limited to, phlebotomy, IVs, injections, vital signs, ECG/EKG, etc.
• Document assessments and study data per regs/GCP; maintain complete source; accurately complete CRFs/eCRFs.
• Obtain informed consent per federal regs, GCP, and IRB requirements.
• Ethically recruit qualified subjects to meet enrollment timelines.
• Complete required/ongoing training; attend investigator meetings/courses; stay current with changing regulations and Flourish policies.
• Schedule and conduct visits per protocol timelines.
• Protect confidentiality per HIPAA and all confidentiality agreements.
• Report AEs promptly; report SAEs to sponsor within 24 hours and notify PI/Sub-I/supervisor.
• Account for and ensure availability of trial materials (study drug, labs, CRFs, supplies).
• Maintain and document communication with Leads, Managers, PIs/Sub-Is, and study team per protocol and policy.
• Perform duties safely, and in a time-/cost-effective manner compliant with Flourish policies.
• Represent Flourish professionally in all interactions.
• Additional duties as assigned by management.

Requirements

• Bachelor's degree or commensurate clinical research work experience
• Phlebotomy and EKG experience is nice to have, but not required
• Preferably 1+ year of experience as a Clinical Research Coordinator
• Familiar with e-source reporting via an electronic platform
• A clear understanding of ICH, FDA, and GCP regulations
• Impeccable organizational skills and attention to detail
• Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
• An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
• High-level critical thinking skills
• Working knowledge of medical terminology and lab collection/processing/storage procedures
• Proficiency with computers and Microsoft Office Suite

Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!

Benefits

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 8 paid holidays and 2 floating holidays.

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.