Job Description
Purpose
Coordinate and manage complex activities throughout the start-up, conduct, and close-out phases of clinical pharmaceutical and device research studies. Ensure timely, accurate, and objective data collection in compliance with companies Research SOPs, federal regulations, GCP, ICH guidelines, IRB requirements, and specific sponsor protocols. All work should align with company Research's Core Values, Mission Statement, and Employee Manual.
Key Responsibilities
- Thoroughly understand assigned protocols and ensure all patient visits and procedures are completed as specified.
- Accurately document patient assessments, observations, test results, and other study-related data following federal regulations and protocol requirements.
- Obtain informed consent from patients in compliance with federal regulations, GCP, and IRB requirements.
- Strategically recruit eligible study subjects to meet enrollment targets within sponsor timelines while upholding ethical and regulatory standards.
- Complete required training promptly.
- Schedule and conduct patient visits in line with protocol timelines.
- Maintain complete and precise source documentation for all study activities.
- Accurately complete and submit case report forms (CRFs/eCRFs) and sponsor worksheets.
- Safeguard the confidentiality of patient and study information in accordance with HIPAA, confidentiality agreements, and company policies.
- Promptly report adverse events to the supervisor and/or Principal Investigator/Sub-Investigator as appropriate.
- Notify the sponsor of Serious Adverse Events (SAEs) within 24 hours of awareness and inform the supervisor and Principal Investigator/Sub-Investigator.
- Manage and track study materials (e.g., study drug, CRFs, lab supplies) to ensure availability throughout the study.
- Maintain consistent communication and document interactions with the Team Lead I, Team Manager, Principal Investigator, Sub-Investigators, and other research staff.
- Participate in required training, conferences, and investigator meetings to remain current with evolving federal regulations and company policies.
- Continuously seek educational opportunities to deepen knowledge of clinical research processes and regulations.
- Perform study-related tasks efficiently and cost-effectively, always adhering to company policies.
- Follow safety procedures in all activities.
- Represent company Research professionally and courteously in all interactions-verbally, in writing, and in appearance-with patients, staff, sponsors, and external partners.
- Carry out additional duties as assigned by management.
Physical & Environmental Requirements
- Primarily office-based work environment.
- Exposure to human bodily fluids and lab processing.
- Direct patient care responsibilities.
- Daily use of computers.
- Occasional evening and weekend work.
- Ability to lift up to 35 pounds, occasionally more.
- Must have a valid driver's license and daily access to a car.
Minimum Requirements
Education:
- Bachelor's degree preferred, but not required.
Experience:
- Ideally, at least 1 years in Clinical Research
- Oncology experience and experience with phase 1 trials is a plus
Skills & Knowledge:
- Solid understanding of clinical research methodologies.
- Strong leadership and team management capabilities.
- Effective collaboration with operational teams.
- Excellent verbal and written communication.
- Proficiency in Office 365 and other relevant software.
- Experience drafting and reviewing Standard Operating Procedures.
- Strong problem-solving, risk assessment, and analytical skills.
- Demonstrated process improvement experience.
- Effective negotiation and conflict resolution skills.
- Ability to multitask, prioritize tasks, and remain flexible.
- Independent thinker able to influence and drive decisions when needed.
* 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.
Job Tags
Full time, Casual work, Work at office, Local area, Flexible hours, Afternoon shift