Job Summary:
In accordance with the Mission, Vision and Values, and strategic directions of Provincial Health Services Authority patient safety is a priority and a responsibility shared by everyone at PHSA, and as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

As the internal Pharmacy resource for Clinical Trials, the Clinical Trials Pharmacy Coordinator is responsible for coordinating and monitoring Pharmacy services provided to support clinical trials involving drugs. Responsibilities include developing drug information and assisting with the development of

Pharmacy policies and procedures as they relate to drug preparation, clinical documentation, patient compliance, and drug accountability; and providing educational materials for patient counseling.

The Clinical Trials Pharmacy Coordinator functions as a member of the interdisciplinary team responsible for planning and implementing clinical trials, liaising closely with Principle Investigators, Study Monitors, Clinical Trials Nurse Coordinators and Clinical Trials Data Coordinators.

Duties/Accountabilities:
1.Prepares written protocol summaries, drug information sheets, compounding and dispensing procedures, parenteral therapy manual monographs, drug accountability records and any other materials necessary to deliver and document the use of medications for clinical trials

1. Develops and disseminates procedures to randomize patients when necessary for selected clinical trials.

2. Provides group in-services and/or individual staff training for procedures that are unique to a clinical trial.

3. Liaises with the Principal Investigator, sponsor and the Clinical Trials Unit Team, in evaluating, implementing, delivering, maintaining and revising mechanisms for the delivery of Clinical Trails medications by performing duties such as:

Reviewing and evaluating Clinical Trials protocols to determine Pharmacy resource impact and feasibility as well as drug dispensing and related costs;

• Attending site initiation and other meetings with sponsors and/or other health care professionals involved in the clinical trial;
• Reviewing and recommending revisions to drafts of the pre-printed orders;
• Preparation of patient teaching information either in the form of handouts or as part of the patient consent form; and
• Revising delivery procedures in response to protocol amendments.

1. Provides problem resolution for Clinical Trials medications by performing duties such as:

• Identifying the need for changes to existing procedures and implementing revisions as necessary;
• Communicating with Pharmacy, Medical and Nursing personnel as well as other paramedicals (ie Lab) to clarify potential problems and minimize risks; and
• Investigating identified internal or external queries and/or problems, risks to safety, or non­ compliance with practice standards and implementing remedial action as necessary.

1. Ensures Pharmacy quality control by performing duties such as:

• Developing, disseminating and up-grading standards for quality control in Pharmacy as related to Clinical Trials;
• Ensuring that randomization procedures and blinding, where necessary, are maintained;
• Conducting regular internal audits of Pharmacy data related to Clinical Trials medications to ensure completeness and accuracy; investigating and resolving discrepancies;
• Conducting regular counts of study drug supplies, and investigating and resolving discrepancies;
• Conducting regular internal audits of Pharmacy practice to ensure adherence to professional practice standards related to drug use, storage, safety, labeling, etc; and
• Recommending to PPL need for ongoing training of staff where necessary.

1. Participates in developing and revising Pharmacy policies and practice standards regarding Pharmacy management of Clinical Trials medications through provision of information and recommendations for new or changed policies to the Pharmacy PPL, Regional Administrator and/or Clinical Trials Unit Manager.

2. Provides Clinical Pharmacy support to ensure appropriate medication therapy for patients on Clinical Trials medications by performing duties such as:

• Monitoring patient compliance to the medication regime defined by the protocol;
• Responding to requests for drug information from study patients or other members of the clinical trials team; and
• Providing general and trial specific counseling (written or verbal} to patients and other health care professionals regarding the study medications.

1. Participates in external audits by sponsors, monitoring agencies, and regulatory bodies by performing duties such as:

• Ensuring that Pharmacy records are completed and available for audit;
• Working with auditors to answer Pharmacy-related questions and interpret Pharmacy documentation and activities as required;
• Monitoring on-site activities of visiting study monitors in the Pharmacy; and
• Conducting study closure procedures, including disposition of remaining study drug supplies, after all study subjects have completed therapy.

1. Provides orientation of new Pharmacists and Pharmacy Technicians regarding the role of Pharmacy in Clinical Trials.

2. Monitors and reports Pharmacy-related Clinical Trials workload to the Clinical Trials Unit Manager or Regional Administrator and the Pharmacy PPL.

3. Participates in interdisciplinary meetings where the Clinical Trials Pharmacists' contribution or expertise is required.

4. Performs other related duties as assigned.

Qualifications:
Education, Training and Experience

• Bachelor's Degree in Pharmacy.
• Hospital residency, or equivalent experience.
• Current licensure with the College of Pharmacists of British Columbia.
• Two (2) years recent related hospital experience including experience in investigational drug or clinical trials management or an equivalent combination of education, training and experience.

Skills and Abilities

• Demonstrated interpersonal skills including the ability to communicate effectively, orally and in writing.
• Demonstrated ability to establish and maintain effective working relationships in a multi­ disciplinary team.
• Demonstrated knowledge and experience with current computer systems for pharmacy and other operating systems.
• Ability to operate related equipment.
• Physical ability to perform the duties of the job.