Job Summary:

In accordance with the Purpose, Vision, Values and Coast Salish Teachings, and strategic direction of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

The Data Coordinator, Clinical Trials (DCCT) receives direction from Principal Investigators and Director, Business & Strategic Initiatives, Cancer Care, or designates.

The DCCT functions as a member of the collaborative, interdisciplinary Clinical Trials Team responsible for planning and implementing clinical trials.  The DCCT participates in the coordination of clinical trials from the protocol review and approval stage through to activation, trial closure and follow-up.

The DCCT has principal responsibility for clinical trials data management, including designing data capture tools, capturing and recording clinical trials data, monitoring and promoting the quality and integrity of data, and preparing summary reports.  Data management is performed in accordance with trial protocol, procedures, guidelines and professional standards of practice.

Duties/Accountabilities:

1.    Performs the data management aspects of clinical trials, in collaboration with other members of the Clinical Trials and Health Care Team, by performing duties such as:

a.    Organizing and maintaining study files and documentation.
b.    Preparing reports and regulatory documents as required, distribution to external individuals and/or groups.
c.    Ensuring that follow-up tests are completed and deficiencies report.
d.    Organizing and conducting study start-up and termination procedures with outside agencies in accordance with Federal Guidelines adapted by each sponsor.
e.    Correlating, organizing, calculating trials data for reports, audits, studies, and other client needs according to established criteria.
    
2.    Captures clinical trials data, as specified in the protocol and in collaboration as required with the Clinical Trials Team, by performing duties such as:

a.    Completing study case report forms and other documents within the required timeframes.
b.    Retrieving or requesting data by identifying selection parameters for retrieval.
c.    Obtaining information from the patient, chart, family, or other health care professional as required.
d.    Utilizing coding systems and resources as required to code and input data as pertaining to Clinical Trials.
    
3.    Designs and develops clinical trial data collection tools, in collaboration with the Clinical Trials Team, by performing duties such as designing forms, tables, and data definitions.

4.    Plans and prepares for external audits in collaboration with other members of the Clinical Trials Team; meets with monitors as required.

5.    Participates in the evaluation, planning, and implementation of clinical trial protocols by performing duties such as:

a.    Reviewing protocols and providing input on resource impact issues related to data management.
b.    Reviewing protocols and commenting on form design and data management requirements.
c.    Providing input into the development of clinical trial budgets.

6.    Participates in identifying patient eligibility for clinical trials by performing duties such as:

a.    Identifying potential protocol-eligible patients from referral documentation.
b.    Reviewing completed data and clinical findings against study inclusion criteria.
c.    Registering/randomizing patients by contacting the study sponsor.
    
7.    Works collaboratively with the Principal Investigator and other members of the Clinical Trials Team to complete and submit appropriate documents for “Ethics” review by the Clinical Investigations Committee at the B.C. Cancer Agency and the Office of Research Services and Administration at the University of B.C.

8.    Provides data clients, including nursing staff in clinic and treatment areas, with information on clinical trials issues such as protocol-specific documentation requirements.

9.    Promotes/provides data quality by performing duties such as:

a.    Quantitative analysis including reviewing records to ensure that captured data is complete and accurate.
b.    Identifying deficiencies and inadequacies in data, updating or correcting deficiencies.
c.    Recommending and implementing improvements to data capture processes.
d.    Obtaining required documentation from internal and external sources.
e.    Providing data for evaluation of efficiency of process and productivity.
    
10.    Communicates with internal and external clients by performing duties such as reporting and answering questions on issues related to data, forms, and reports.

11.    Assists in the orientation of new DCCTs by performing duties such as mentoring and providing guidance to new staff.

12.    Maintains submitted data in a secure and confidential manner by following established policy, procedure, and professional standards of practice for assigned work.
    
13.    Participates in developing and updating the Clinical Trials Policies and Procedures Manual by performing duties such as drafting data management procedures.

14.    Attends and participates in a variety of meetings as required.

15.    Travels to national and international events and meetings related to clinical trials as requested and approved.

16.    Performs other related duties as assigned.

Qualifications:

Education, Training and Experience

•    Completion of a recognized Health Information Management Program with eligibility for membership in the Canadian Health Information Management Association at the Certificate level.
•    Two (2) years recent related data management experience in a clinical trials environment or an equivalent combination of education, training and experience.
•    Certification such as Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Clinical Research Associate/Coordinator Certification preferred.

Skills and Abilities

•    Demonstrated relevant clinical research knowledge.
•    Demonstrated ability to perform data capture, management and retrieval using automated or manual information systems.
•    Demonstrated ability to deal with others effectively.
•    Demonstrated interpersonal skills including the ability to communicate effectively both verbally and in writing.
•    Demonstrated ability to organize work and set priorities.
•    Demonstrated ability to work independently.
•    Demonstrated ability to operate related equipment.
•    Physical ability to perform the duties of the position.
•       Demonstrated skills in CPR techniques.

** Please note: Support for nomination with the BC Provincial Nominee Program is not a guarantee, entitlement or an employee benefit after receiving a full time job offer with PHSA**