Interpersonal factor

• As a professional all services delivered needs to be in line with the Cancercare values, of CARE. Each task needs to be consistently executed whilst at all times displaying a positive influence on all stakeholders and within the general working environment. It is expected from the employee to deliver all tasks reflecting a willingness to operate outside the scope of the job description as per operational requirements. The factors below cannot therefore be reviewed in isolation.
• To display the company values: C – Compassion, A – Accountability, R – Respect, E – Ethics (CARE) 

Preparation for study

• Meeting with sponsor delegate to discuss all aspects of the site and requirements to run the study and tour of facility.
• Required to travel for investigator meetings.  Ensuring you have a valid passport.
• Organize with Principal and sub-investigators for protocol overview and site initiation meeting. Review of study files with the sponsor delegate.
• Drawing up and designing templates for the source documents used by the investigators according to specific protocol requirements.
• Site must at all times meet all the required international standards to run an oncology study
• Ensuring coordinator is extensively trained on the study protocol. 
• To ensure that everything is in place to start recruiting patients for the study
• To ensure that the correct data is collected and all special investigations are done for specific visits according to the study protocol.

Data collection and reporting, paper and electronic format

• Intensive online training on the use of electronic CRFs.
• Enter study specific data onto source documents and paper case report forms or electronic case report forms. Data entering and clarifications to be done within the sponsor specified timelines.
• Gather the required data to report SAE’s, complete the necessary SAE forms and send through to Sponsor/ Drug Safety within 24 hours.
• To ensure proper use of eCRFs for clinical data capture
• To ensure that all data is entered and corrected within study specific timelines and ready for Clinical Research Associates to monitor and be ready for data base locks etc.
• To ensure that Drug Safety Department is alerted to Serious Adverse Events.  This ensures that other participating sites are alerted.

Clinical Trial Co-ordination and management

• Ensuring that the latest versions of protocols and ICFs are used.
• Shipping or uploading of radiology imaging, ECG’s etc. to the central reviewers and biological samples to central laboratories.
• Phone IVRS/IXRS to alert sponsor about, screenings, end of treatment, dose adjustments, dispensing, etc. and to randomize patients to treatment arms.
• Filing regulatory and other essential documents in the investigator site files according to sponsor guidelines as well as those of GCP
• Responsible for electronic parallel system filing of all confidentiality agreements, study feasibilities and study protocols
• Preparing and reviewing all clinical source data (patient files, regulatory documents) for international or local (MCC, ethics committee) audits
• Send weekly emails to Financial administrator in order to complete orders of work done
• Prepare billing instructions
• Regularly do stock check of blood kits, dipsticks for expiry dates and additional kits needed. 
• Also check stock of blood pressure machines, electronic diaries or other trial specific apparatus.
• Ensure valid calibration certificates for all medical devices needed
• Have good communication to the study team and knowing who to contact when necessary.
• Ensuring that new amendments relating to protocols and ICFs are used. This is important for patient safety and protocol requirements.
• To ensure that all radiology imaging, ECG’s etc. are shipped or uploaded to the Central Reviewers timeously for their independent reporting.
• To ensure that IVRS/IXRS calls are made timeously according to sponsor requirements.
• To ensure that these files are up to date and complete in the case of clinical audits.
• Reducing possible audit findings. To adhere to GCP. Ensuring the integrity, reliability and quality of study data from our study site.
• Ensuring up to date information regarding financial impact of work done
• Ensuring up to date information regarding financial impact of work done
• Ensuring that expired blood kits and dipsticks are not used in error and that the required devices are available for the patient’s use as required by the protocol.
• Calibration of all medical devices as per SOP
• Good communication with the sponsors and vendors (verbal and in writing) ensures clear and correct communication about study issues.

Presentations and attending of academic meetings

• Giving presentations both for the clinical research unit and  practice on relevant clinical study topics
• To educate and give training on clinical study topics to ensure better understanding of the importance of clinical research

Patient management

• Collecting and review of all patient medical history for reviewing by investigator before patient is enrolled into screening
• Preparing patient files for visits according to protocol specific requirement for the visits.
• Arrange radiology, cardiology or other special investigations on the correct time points as specified by the study protocol.
• Perform and document the patient’s vital signs, weight, urinalysis and ECG on scheduled and unscheduled visit days,
• follow-up on blood results and adverse events
• Take telephone calls from patients re AE’s etc.
• Collecting, centrifuging (spinning-off) and handling (packaging) of blood samples in preparation for lab analysis in the absence of the study nurse.
• Explaining and having patient’s complete quality of life questionnaires at the correct time points in the correct manner.
• To ensure patient’s eligibility before enrolment
• Ensuring that new amendments relating to protocols and ICFs are used. This is important for patient safety and protocol requirements.
• To ensure that all radiology, cardiology and other special investigations are done at the correct time points according to study protocol.
• To ensure patient safety on treatment days
• To ensure the blood samples is correctly handled and prepared for laboratory analysis
• Ensuring that quality of life questionnaires are completed correctly and completely according to protocol guidelines.

Required minimum education:

• 3 year Diploma or degree in medical or scientific field, Good Clinical Practice certificate and computer literate

Required minimum experience:

• 2 year Clinical research experience

Required minimum work-related experience:

• 2 year Clinical research experience