Job Description

To coordinate Oncology studies and manage data

Coordinate all clinical study activities between International Sponsors, Doctors, Nursing staff, outside vendors (Radiologists, Cardiologists, Pathologists or other according to protocol) and the patient. Collect reports and manage all clinical data to the sponsor company.

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 xe2x80x93 Respect, E xe2x80x93 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 SAExe2x80x99s, 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, ECGxe2x80x99s 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, ECGxe2x80x99s 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 patientxe2x80x99s 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 patientxe2x80x99s 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 AExe2x80x99s 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 patientxe2x80x99s complete quality of life questionnaires at the correct time points in the correct manner.
• To ensure patientxe2x80x99s 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

Cancercare SA