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.
Required Skills
- Must have oncology clinical research experience
- Minimum of two years of clinical research experience
Preferred Skills
- Bachelor's degree preferred, but not required
- Clinical skills highly preferred: vital signs, EKG/ECG, phlebotomy, and injections
- 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
Schedule/Shift
Shift: Monday-Friday, 8:30 AM - 5 PM (occasional weekends)
* We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
* As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.