Download 2. Reporting/Working Relationships

ROYAL ADELAIDE HOSPITAL
JOB AND PERSON
SPECIFICATION
Title of Position
Administrative Unit
Senior Clinical Research Co-ordinator (SCRC)
Royal Adelaide Hospital
Classification Code:
AHP-2
Discipline Code:
Type of Appointment:
 Permanent
 Temporary
Term .........
 Other
Term ...............
Division: Internal Medicine Services
Branch: Thoracic Medicine
Section: Clinical Trials
Position Number:
Position Created:
Job and Person Specification Approval
All excluding senior positions
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CEO or delegate
Commissioner for Public Employment
JOB SPECIFICATION
1.
Summary of the Broad Purpose of the Position in Relation to the Organisation's Goals
The Senior Clinical Research Coordinator (SCRC) assists in the co-ordination of clinical
trials conducted by the Unit. If the co-ordinator is allocated the role of primary trial coordinator for a study, the role will include the overall administrative responsibility of coordinating a trial.
Participate in the development, coordination and implementation of research and
administrative strategies essential to the successful management of clinical trials research
conducted by Principal Investigator(s) in the Department of Respiratory Medicine at the
Royal Adelaide Hospital; perform a variety of independent duties involved in the
organisation including oversight, documentation and compilation of clinical research data.
The SCTC may work collaboratively with researchers in the Lung Research Laboratory,
Hanson Centre for Cancer Research and RAH departments on specific research projects.
The clinical trial co-ordination and research role of the SCRC contributes to the
advancement of scientific knowledge of treatments for patients with airways diseases.
2.
Reporting/Working Relationships
Reports to the Head, Clinical Trials Unit, supervised for the specifics of clinical trials and
day to day work by the Lead Co-ordinator for the appropriate trial and works closely with
other clinical trial co-ordinators in the Unit. For day to day general administrative matters
relating to the Unit, relates to the Clinical Research Administrator. The SCRC supervises
co-ordinators and may be allocated a lead co-ordinator role.
3.
Special Conditions
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Some out of hours work may be required to meet the needs of the clinical trials unit.
Interstate or overseas travel to attend meetings concerning clinical trials will be required.
4.
Key Competencies/Performance Indicators
4.1
CLINICAL TRIALS
The Senior Clinical Research Co-ordinator will be responsible for the co-ordination of
clinical
trials (in association with any Lead Co-ordinator/s) by the following:
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Follow ICH GCP guidelines and approved trial protocols and work within relevant
policies of the Hospital.
Assist the Principal Investigator and/or lead co-ordinator with clinical trial
submissions, reporting, and other approval requests required by the RAH Ethics
Committee.
Develop recruitment strategies, actively recruit volunteer patients and ensure
recruitment targets are met.
Perform prescribed clinical procedures and assessments, dispense and administer
trial medications as required by the trial protocol.
Prepare work schedules and assist the Principal Investigator with
evaluating/preparation of budgets.
Collect and enter trial data, maintain quality and accuracy of data to auditable
standards, maintain medical notes.
Maintain requirements of RAH Pharmacy and other relevant RAH
procedures/requirements.
Liaise with/train medical, nursing, technical and administrative staff assisting with
trials.
Maintain appropriate reporting.
Liaise with sponsor personnel as required.
Prepare for external audits of trials as required.
4.2 DELIVERY of CARE and CORE VALUES
The Senior Clinical Research Coordinator promotes a planned, integrated, outcome
focused approach to the delivery of high quality care by:
 acting as a role model;
 demonstrating thorough assessment of the health needs of individuals/ groups of
patients;
 ensuring that protocols (however titled) are effectively implemented;
 using planned, systematic processes to implement care for specific individuals and/or
groups of patients;
 being able to reprioritise activities in response to sudden changes in the care delivery
context;
 undertaking continuous evaluation and reassessment of the outcomes of care;
 maintaining timely, accurate and appropriate verbal and written communication
processes; contributing to the development of, and working effectively within, the unit
/ department’s agreed model of care delivery;
 ensuring patients retain their dignity through being clean, comfortable and safe;
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 ensuring that care is effectively integrated into total patient management by liaising
with medical, allied health and clerical/administrative staff;
 ensuring that own care delivery is consistent with the unit / department and
corporate objectives, philosophies, policies and procedures;
 promoting the improvement of patient outcomes and recovery processes by assisting
in the formulation of research projects and policy and practice guideline
development;
 developing and participating in specific / unit / department projects as determined
from time to time.
 assisting in the development and achievement of the unit’s philosophy and
objectives; supporting the Head of Unit and other staff in the coordination of care
delivery.
 Accepting accountability for own actions;
 Accepting accountability for activities delegated to others;
 Maintaining currency in research knowledge and applying current research
techniques;
 Contribute to the ongoing research activities of the Unit by assisting the Head in
identifying and seeking sponsorship interest.
 Contribute/undertake collaborative research with researchers in related fields within
the RAH/IMVS Hanson Institute and in other clinical trial units in the Hospital and
assist in preparation of publishable papers as required.
 Perform other related duties incidental to the work described herein.
4.3 EQUAL OPPORTUNITIES
The Senior Clinical Trial Coordinator contributes towards the provision of a healthy, safe
and equitable working environment by adhering to the principles and standards of Equal
Employment Opportunity Legislation, which:
 ensures employees are recruited, selected, trained, transferred and promoted solely
on the basis of merit without regard to age, marital status, physical disability,
intellectual impairment, pregnancy, race, sex or sexuality;
 ensures all employees in the workplace are treated in a fair and equitable manner;
and
 identifies and eliminates discrimination, bullying and harassment in the workplace.
4.4 SAFE ENVIRONMENT:
The Senior Clinical Research Co-ordinator ensures the provision of a safe environment
for patients, visitors and staff in the department by:
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complying with relevant legislation, policies and guidelines
reporting all accidents, incidents and near misses;
supporting a pro-active approach to risk management;
undertaking preventive behaviours and processes;
fostering activities which relate to each of the elements of safe environment;
supporting positive ways of managing the pressures of work;
ensuring compliance with record and reporting systems.
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The Senior Clinical Research Co-ordinator ensures that staff and other persons in their
work areas are safe from risks to health and safety by:
 carrying out responsibilities as detailed in organisational occupational health, safety
and injury management (OHSM&IM) policies and procedures;
 implementing and monitoring relevant OHS&IM policies and procedures within their
work area;
 identifying hazards, assessing risks and implementing, monitoring and maintaining
hazard control measures in consultation with staff and relevant committees;
 participating in OHS&IM planning;
 providing staff with the necessary information, instruction, training and supervision
to effectively and safely carry out their work;
 maintaining relevant OHS&IM documentation; and
 consulting with health and safety representative, committees and staff on changes
to the workplace with have the potential to impact on health and safety.
The elements of a safe environment refer to:
 accident prevention;
 occupational health and safety;
 therapeutic nutrition and hydration of patients;
 infection control;
 safe diagnostic and treatment interventions;
 prevention of sexual harassment;
 prevention of negatively discriminating behaviour;
 cultural sensitivity;
 dress, attitude, and behaviour appropriate to the context of the organisation.
Acknowledged by Occupant ...........................................................
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PERSON SPECIFICATION
ESSENTIAL MINIMUM REQUIREMENTS
EDUCATION:
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A degree in Science, Health Science, Allied Health or other related discipline.
PERSONAL ABILITIES/APTITUDE/SKILLS:
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Effective communication and interpersonal skills.
Excellent numeracy and literacy skills.
Excellent organisational skills.
Able to precisely follow written or verbal instructions.
High level of analytical and problem resolution skills.
High level of skills in the use of personal computer.
High level of team working skills.
High level of person integrity.
Commitment to personal and professional development.
EXPERIENCE:
 5yrs post graduation experience
 Minimum of 5 years working as a clinical research co-ordinator or equivalent position, in
phase 1-3 trials with minimal supervision.
 General medical knowledge of diseases and their treatments.
KNOWLEDGE:
Knowledge of ICH Good Clinical Practice guidelines/NHMRC human research guidelines.
Knowledge of research study methods.
Knowledge of issues of Occupational Health, Safety and Welfare and Equal Employment
Opportunity.
Understanding of the role of the Clinical Trials Coordinator.
DESIRABLE REQUIREMENTS
EDUCATION:
An honours or higher degree involving a significant research component or significant
research experience.
PERSONAL ABILITIES/APTITUDE/SKILLS:
Desire to develop leadership and management skills
EXPERIENCE:
Experience with spirometry, intravenous management, ICU or emergency departments.
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Demonstrated competence in acute nursing care.
Knowledge of respiratory diseases and their treatments.
KNOWLEDGE:
Familiarity with Microsoft office operating systems
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