Clinical Research Coordinator

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 - 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
- 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 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

**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