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Advanced Clinical Trials Specialist Oncology / Full Time / San Diego

Job ID JR132367 Date Posted 12/30/2022
San Diego, California
  • Frost Street Building
  • Day
  • Regular
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Shift Start Time:

Shift End Time:

Additional Shift Information:

Weekend Requirements:

On-Call Required:


Hourly Pay Range (Minimum - Midpoint - Maximum):

$49.377 - $63.712 - $78.048

The stated pay scale reflects the range that Sharp reasonably expects to pay for this position.  The actual pay rate and pay grade for this position will be dependent on a variety of factors, including an applicant’s years of experience, unique skills and abilities, education, alignment with similar internal candidates, marketplace factors, other requirements for the position, and employer business practices.

What You Will Do
Ensures that all clinical trials are conducted in accordance with the protocol requirements, the Food and Drug Administration (FDA), and the Office for Human Research Protections (OHRP) guidance and regulations. Demonstrates commitment to providing quality service, support and responsiveness to research subjects, physician investigators, trial sponsors, hospital staffs (clinical and administrative) and contract research organizations (CROs) as applicable.

Required Qualifications

  • 2 Years Clinical Research Coordination experience
  • 2 Years Clinical experience in the therapeutic area of the trial
  • AHA Basic Life Support for Healthcare Professional (AHA BLS Healthcare) - American Heart Association -REQUIRED

Preferred Qualifications

  • Bachelor's Degree in Nursing
  • Oncology Certified Nurse (OCN) - Oncology Nursing Certification Corporation -PREFERRED

Other Qualification Requirements

  • RN License or doctoral degree required.

Essential Functions

  • Communication
    Responds to all sponsor/CRO communication within one business day of becoming aware.
    Communicates with designated sponsor trial monitors/auditors throughout the trial with any issues or questions regarding the trial.
    Completes Case Report Forms (CRFs) and queries within the protocol specified time frame, as needed.
    Maintains study enrollment logs and investigational product logs per protocol requirements.
    Reports all Serious Adverse Events (SAEs) to the trial sponsor and SHC IRB per protocol requirements and IRB policy.
    Documents all sponsor and IRB communication.
    Prepares long-term storage for records upon trial completion.
  • Demonstrates initiative and accountability
    Demonstrates flexibility in work practices.
    Supports organizational and department cost containment.
    Takes initiative in using time effectively.
    On-call time may be a requirement of the position.
    Actively sets priorities and adjusts to unscheduled situations.
    Accepts responsibility for own actions and outcomes.
    Initiates communication with others to ensure job is completed successfully.
  • Professional responsibilities
    Represents SHC and the clinical trials to the community in an ethical and professional manner.
    Attends sponsor investigator meetings and training as required.
    Maintains current license and required certifications.
    Available for touring entities, attending speaking engagements, providing education or other function that promotes clinical research at SHC and its affiliates.
    Mentors nursing students or psychology pre-doctoral interns (SMV) by providing education and training in the conduction of clinical trials.
    Responsible for orienting and training staff in any new regulations and requirements associated with the conduct of clinical trials prior to government or sponsor implementation. Ensures that training is completed within the required timeframe.
    Responsible for leading staff training and ensuring that staff competencies are completed within the required timeframe, as needed.
    Acts as a resource to the department for the development of source documentation and study-specific tools in support of high quality research outcomes.
    Willingly demonstrates teamwork in support of entity accreditation/certifications through positive collaboration with co-workers.
  • Regulatory responsibilities
    Completes all trial sponsor regulatory and Institutional Review Board (IRB) application requirements as needed.
    Conducts clinical trials only after receipt of the SHC IRB approval letter and fully executed CTA.
    Submits ongoing documents for IRB approval (e.g., protocol amendments, updated Investigator Brochures, revised consent documents, recruitment materials, etc.) as needed.
    Submits Continuation Review documentation to the IRB prior to the deadline as needed.
    Provides trial-specific education to entity staffs and or SHC and affiliate personnel associated with the conduct of the trial.
    Collaborates to ensure investigational product is managed and dispensed to study subjects according to Good Clinical Practice (GCP) Guidelines, FDA and State regulations, SHC policies and the trial protocol.
    Conducts all trial activities per the requirements of the protocol and as delegated by the principal investigator and research managers as applicable.
  • Trial coordination
    Complies with all clinical trial billing procedures for consented subjects.
    Consistently documents all study-related activities and maintains subject records as complete and accurate (ALCOA).
    Provide quality care to research patients and their families by complying with the Sharp Mission and Goal statement in pursuit of a high level of patient satisfaction.
    Pre-screen, recruit and screen patients for participation per trial inclusion/exclusion criteria.
    Participates in a thorough informed consent process which explains to subjects, legally authorized representatives (LAR) and family the aims, procedures and possible benefits or risks associated with participation. Informs participants of their right to withdraw consent to participate in research at any time.
    Act as a liaison between patients, hospitals, physicians, investigators and study personnel during conduction of trials.
    Informs Principal Investigator, Sub-Investigators, Research Director, and research managers of all aspects of the trial and condition of the subjects.
    Schedules patient visits, including all required study procedures and sponsor monitoring visits.
    Assists investigators in obtaining contracted patient enrollment for each protocol.
    Performs trial specific procedures or supervises the performance of procedures to meet the exacting requirements of the trial protocol.

Sharp HealthCare is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability or any other protected class

Oncology Certified Nurse (OCN) - Oncology Nursing Certification Corporation; AHA Basic Life Support for Healthcare Professional (AHA BLS Healthcare) - American Heart Association; Bachelor's Degree in Nursing
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