Job Description

Responsibilities

ESSENTIAL JOB FUNCTIONS:

• Read, understand, and ensure the completion of all protocol required patient visits and procedures.
• Clearly and concisely document patient assessments, treatments, observations, test results and other study related information per federal regulations, protocol requirements and GCP Guidelines.
• Obtain patient informed consent, and reconsent as required, according to federal regulations, GCP and IRB requirements while educating patients on study requirements, timelines, and visit expectations.
• As Senior CRC, lead and mentor other research staff and serve as an escalation point and SME.
• Is diligent in enrolling qualified study participants into appropriate protocols within the sponsor's timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines.
• Complete all required training in a timely manner.
• Schedule and conduct patient visits according to protocol requirements and timelines.
• Maintain written source documentation of patient visits and protocol related activities per ALCOA guidelines.
• Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets and respond to queries generated by the sponsor in a timely manner.
• Maintain confidentiality of all patient and protocol activities and information as appropriate and as bound by Confidentiality Agreements between company and sponsors, and between company and other entities, as well as HIPAA regulations.
• Promptly document and report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.
• Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to the supervisor, Principal Investigator and/or Sub-Investigator immediately.
• Account for clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study.
• Maintain ongoing communication with Team Lead I; Team Manager/Research Manager; Principal Investigator; Sub-Investigators and other people assisting with the trial and documenting these communications according to protocol requirements and company policies.
• Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and company policies.
• Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
• Attend Investigator Meetings, SIVs, team meetings, and/or other trainings as directed.
• Perform all study-related duties in a time- and cost-effective manner in adherence with company policies.
• Represent Clinical Trials in a professional and courteous manner (verbal, written and in appearance) when interacting with internal staff, sponsors, IRBs, patients/participants, nursing and medical staff members of various clinics, hospitals, and physician's offices.
• Additional duties as assigned by management.

Required Skills

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

• Work is normally performed in a typical interior/office work environment.
• Travel required but minimal.
• Exposure to human bodily fluids.
• Laboratory processing procedures.
• Participant care.
• Daily computer use.
• Occasional night and weekend work schedules.
• The ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
• The ability to drive, and daily availability of an automobile.

MINIMUM REQUIREMENTS:

• Bachelor's degree preferred but not required.

Experience:

• Education: Bachelor's degree preferred; however, is not required. Clinical research certification is a plus
• Experience: A minimum of 1-3 years' clinical research experience, with at least 1 year in oncology. Experience in early phase oncology research preferred.

Preferred Skills

Knowledge and Skills:

• Exceptional knowledge of clinical research methods.
• Strong management and leadership skills.
• Demonstrated ability to collaborate and align with operations.
• Excellent oral and written communication skills.
• Excellent computer skills to include Office365 products.
• Experience in writing and reviewing Standard Operating Procedures.
• Strong problem solving, risk assessment and impact analysis abilities.
• Demonstrated experience in process improvement.
• Strong negotiation and conflict management skills.
• Flexible and able to multi-task and prioritize competing demands.
• Ability to think independently and influence when appropriate.
• Develops and implements key initiatives in the department.
• Identifies and implements process improvements for increased efficiency.
• Builds and fosters relationships across teams.
• Serves as preceptor, mentor and subject matter expert in department.
• Demonstrates strong critical thinking and decision-making skills.
• Continually demonstrates core values and is regarded as a leader.
• High proficiency of skills set.

Schedule/Shift

Monday-Friday; Normal Business Hours

* 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.

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