You Make Us Grow. You Make Us Sharp.

Hours:

Shift Start Time:

Variable

Shift End Time:

Variable

AWS Hours Requirement:

8/40 - 8 Hour Shift

Additional Shift Information:

Weekend Requirements:

As Needed

On-Call Required:

No

Hourly Pay Range (Minimum - Midpoint - Maximum):

$42.790 - $55.210 - $61.840

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
Organizes and coordinates neonatal clinical research studies from IRB/FDA approved protocols. Performs clinical research studies in compliance with GCP/ICH adherence. Provides research support to Sharp neonatologists in their role as investigators and/or sub-investigators; sharing in the responsibility for successful completion of clinical research studies at Sharp. Maintains working knowledge of assigned research projects and facilitates their success.

Required Qualifications

• Bachelor's Degree In healthcare related field or Registered Respiratory Therapist (RRT).
• 5 Years Experience in a related field.
• Experienced with good clinical practice techniques and accurate documentation.

Preferred Qualifications

• Certified Clinical Research Coordinator (CCRC-ACRP) - The Association of Clinical Research Professionals -PREFERRED

Other Qualification Requirements

• Registered Respiratory Therapist (RRT) or Bachelor's degree in healthcare related field required.

Essential Functions

• Communication and teamwork
  Screens, recruits, and evaluates patients for participation in studies per research protocols.
  Acts as a liaison between the patients, hospital, physicians and study personnel during implementation of assigned studies.
  Validates understanding of coordination of plan of care and is responsive to questions or concerns.
  Schedules patient visits, study procedures, and sponsor site visits.
  Documents telephone communications between the investigative (research) site and the study sponsors.
  Coordinates and communicates progress of research protocols.
  Validates patients' and families' understanding of plan care.
• Patient and family advocate
  Validates patient's understanding of study protocols and objectives.
  Assists the patient with study-related requirements and procedures.
  Participates in the informed consent process.
  Considers patient's perspective about research studies, procedures, problems and issues, responding appropriately to their needs.
  Patients' perceive as responsive, caring and effective.
  Promotes the experience of participating in an out-patient or in-patient research study requiring RN scope of practice.
• Promotes and advocated research in discovery of best practices
  Knowledgeable regarding current clinical practices and protocols, including eligibility criteria.
  Contributes to evaluating desirability and feasibility of participating in new research studies by representing Sharp Clinical Research programs at nationwide investigator meetings.
  Acts as a protocol resource person for specialists and clinical staff participating in research studies.
  Implements patient recruitment strategies.
  Elicits and shares research study updates and results, interfacing with investigators and site coordinators at participating institutions nationwide.
• Research management
  Evaluates the patient at research study visits and communicates findings to the physician investigator.
  Conducts or delegates chart reviews to evaluate compliance with and results of study.
  Ensures completion of principal investigators and sponsor's research data queries per deadlines.
  Provides clinical research monitors with required documents per site visit.
  Prepares long-term storage for study records after research study is completed.
• Research study implementation
  Assists the investigator in obtaining the required contracted patient enrollment for each study, using the protocol's inclusion/exclusion criteria.
  Validates clinical staff's understanding of responsibilities related to research protocol implementation and documentation.
  Monitors implementation of study protocols per IRB standards and study parameters.
  Dispenses and controls all research study drugs per FDA regulations.
  Performs study-specific procedures or supervises the performance of specific procedures to meet protocol requirements (e.g., EKG, treadmill, phlebotomy, and hospital procedures).
  Maintains current, accurate flow sheets, case reports, data bases, and study logs (e.g., screening, enrollment, and drug dispensing/drug return logs).
  Documents and communicates adverse events per research protocols and regulatory standards.

Knowledge, Skills, and Abilities

• Knowledge of medical terminology and clinical research requirements.

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

Certified Clinical Research Coordinator (CCRC-ACRP) - The Association of Clinical Research Professionals; Bachelor's Degree