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IDS Pharmacist - Investigational Drug Services

Parkland Health and Hospital System (PHHS)
United States, Texas, Dallas
5201 Harry Hines Boulevard (Show on map)
Nov 12, 2024

Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a diverse healthcare legacy that's served our community for more than 125 years. Put your skills to work with us, seek opportunities to learn and join a talented team where patient care is more than a job. It's our passion.

PRIMARY PURPOSE

The primary purpose of the investigational pharmacist is to ensure safe, effective, and appropriate investigative drug therapy for all patients treated at Parkland Health. The research pharmacist provides oversight and guidance for use of investigational medications with the primary goal of promoting patient safety for those participating in human clinical drug trials. The research pharmacist promotes patient safety, regulatory compliance, and safe dispensation of investigational drugs. They also provide consultation to investigators and research staff.

MINIMUM SPECIFICATIONS

Education

- Must have a bachelor's degree in pharmacy or Pharm. D degree from an accredited school of pharmacy.

Experience

- Prefers previous work experience with investigational drug services and inpatient clinical services.

- Prefers previous work experience with hazardous drug handling/preparation in a clinical setting.

Equivalent Education and/or Experience

- None.

Certification/Registration/Licensure

- Must be a Registered Pharmacist in the State of Texas.

- Prefer preceptor certificate from the State Board of Pharmacy to be eligible to accept students on rotations.

- Must have completed an ACPE accredited course in IV sterile compounding.

- Must have completed the certificates for good clinical practice for conducting research, human subject protection, etc within 90 days of hire date.

Required Tests for Placement

- None.

Skills or Special Abilities

- Must possess good oral and written communication skills.

- Must have excellent computer skills.

- Must possess knowledge of drugs, procedures, equipment, common disease states and patient care monitoring within the assigned care areas.

- Required appropriate pharmacy specific mathematical skills.

- Must possess good organizational skills.

- Must have good knowledge of USP chapters 797 and 800.

Responsibilities

1. Demonstrates effectiveness and efficiency in routine and complex order preparation, review, and verification by authorized investigators for therapeutic appropriateness, duplications, side effects, effectiveness, lab monitoring, etc for inpatient, oncology and outpatient investigational medication orders. Facilitates and ensure appropriate formulary use for standard of care medications under the research protocol and the build for EPIC willow research medication order and Alaris pump are accurate.

2. Demonstrates accuracy and efficiency in computer entry/verification and/or preparation of investigational drug orders/order processing/preparation and compounding of sterile products according to the research protocol, USP 797 and 800, good clinical practice guidelines, and institutional procedures.

3. Responsible for evaluating research protocol and investigator brochure and pharmacy manual, preparing study budget letter, preparing study synopsis and drug information sheet, creating various dispensation procedures, study forms and physician order form and Beacon research treatment plan, learning various sponsors' clinical trials platforms to complete various protocols tasks. Works closely with investigators, research nurses/coordinators/managers, and sponsors to optimize research protocols while maintaining institutional procedures and regulatory compliance.

4. Responsible for maintaining accurate recordkeeping, shipping, ordering, receiving, storage, retention/destruction and related inventory activities in compliance with good clinical practices and the requirements of individual clinical trial sponsors.

5. Responsible for corresponding with sponsors, investigators and research coordinators regarding various clinical trial issues throughout the study. Responsible for attending site initiation visit, monitoring and close out visits, quality assurance audits and other related meetings with clinical trial sponsors and their representatives, regulatory agencies and others.

6. Responsible for adequate investigational drug and/or supplies are ordered for the clinical trial and maintain adequate par level for study drug and/or supplies. Responsible for investigational drug return or destruction as required by sponsor. Assist primary investigator with cost effectiveness of the needed study drug if need to be purchased. Responsible for preparing invoices for investigational drug/supply purchase and ensures accurate process of all charges for each research protocol.

7. Communicates and trains pharmacy staff anticipated to participate in any aspect of the clinical investigational drug trial.

8. Performs QM, QA and PI on a monthly basis as part of nursing/pharmacy liaison responsibilities. Identifies and implements necessary charges and monitors the results of these programs to ensure continues performance improvement and area compliance. Provide timely information pertaining to pharmaceutical supplies, drug usage and compatibility, state and federal regulations regarding drug controls, and The Joint Commission standards to designated areas.

9. Educates and communicates effectively with patients on the study medication(s) to ensure that patients are informed of proper investigational drug usage and knowledge of potential side effects. Consults and evaluates all available patient information both documented and through patient interview to ensure patient and caregiver have given all the necessary information about the investigational medication.

10. Acts as a resource to physicians, nurses, investigators, study coordinators and patients concerning questions/support related to drug distribution and drug information services in line with hospital & departmental procedures. Actively attends & participates in departmental staff meetings & staff development programs to maintain current knowledge & understanding of procedures and/or new programs.

11. Provides preceptorship and mentoring, training of pharmacy students, pharmacy residents, technicians on individual teams and/or in areas as well as new employees and other healthcare providers. Activities should include providing both practical and didactic experiences. Acts as a role model for future pharmacists and/or as a positive representative of clinical pharmacist functions and abilities.

12. Effective in day-to-day supervision of IDS technicians. Assists with the selection, mentoring, and evaluation of support personnel to ensure maximum utilization of individuals while providing optimal services. Effective in professional interactions with all pharmacy staff. Contributes to overall maintenance of quality & compliant pharmacy services.

13. Identifies ways to improve work processes and improve customer (internal as well as external) satisfaction. Makes recommendations to manager, implements, and monitors results as appropriate in support of the overall goals and mission of Parkland Health.

14. Monitors the latest developments, advancements, and trends in clinical pharmacy & applicable laws, regulations, policies, and guidelines that impact pharmacy. Participates and attends local, regional, national seminars/workshops. Reads professional journals and maintains appropriate licensure. Integrates knowledge gained into current work practices and shares with peers. Promotes adherence to all laws and procedures in daily practice and mentoring of peers. As necessary, seeks guidance with management to gain understanding or suggest improvement initiatives.

15. Participates in department committees and special projects as assigned in order to improve the pharmacy department services and overall efficiency in support of the goals of the department and Parkland Health. Suggests and implements with pharmacy leadership new processes, systems, or procedures to enhance patient safety and the prevention of adverse events or errors in any step of the investigational medication management process.

16. Maintains a positive working relationship with job related contacts such as management, health care professionals, staff, investigators, sponsors and clinical research associates and other employees in order to improve overall pharmacy services and to ensure that all job contacts are professional and productive. Effective in communication of care issues and professional interactions with peers and associates.

Parkland Health and Hospital System prohibits discrimination based on age (40 or over), race, color, religion, sex (including pregnancy), sexual orientation, gender identity, gender expression, genetic information, disability, national origin, marital status, political belief, or veteran status.As part of our commitment to our patients and employees' wellness, Parkland Health is a tobacco and smoke-free campus.

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