Clinical Research Coordinator (contract appointment: 1 year)
Faculty Health Sciences Department Pharmacology Clinical Research Coordinator (contract appointment: 1 year) Job ID: 2357 We have an exciting opportunity for an enthusiastic person to join our team as a Clinical Research Coordinator. The incumbent is expected to: provide support, coordination and leadership of our ARV paediatric registry and pharmacovigilance programme based at the department and ramifying to outlying clinics; ensure smooth, accurate progress of data collection at the outlying study sites, and subsequent transfer to the centre as well as its electronic capture to the RedCap data base; supervise the personnel involved in the data collection, which includes recruitment of study participants, scheduling follow-up, and facilitation of patient’s continued participation; review and certify the data submitted on the Case Report Forms for accuracy and compliance with the study protocols; Identify and provide the training requirements for the personnel in the unit; and willing to work under the directorship of the Principal Investigator (PI). This is a one-year contract appointment with a possibility of renewal subject to performance and availability of funds. Although based in the Department of Pharmacology, the incumbent will work (or lead a team) in the outlying clinics to collect patient information. Duties and responsibilities:
Management: Manage and coordinate activities of the registry programme as well as other related departmental activities as advised by the principal investigator.
Recruitment: Oversee the screening of potential patients for eligibility to the study and reviews all the elements of the screening process, i.e., inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient willingness to participate in the study.
Data Management: Oversee the data collection by field personnel. This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc.); abstraction of data for publications, or data collection from outside physicians’ offices. Audits and manages data from and into the database. Prepares forms and reports, compiles and analyses data, statistics, and other materials for reports. Conducts study visits, obtains and documents information within the time-frame specified.
Study Regulations: Aware of study regulatory status and keep an up to date copy of regulatory documents. Assist study personnel with the informed consent process and ensure that the patient fully understands what is required of them throughout the study. Ensure that study personnel follow through regularly with the patient reminding them of visits and compliance. May monitor any outward effects or issues regarding patient safety and report this to the Principal Investigator or Physician.
Decision Making and Problems Solving: Evaluate information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolve complex situations and refer non-solved issues and questions with recommendation to the PI.
Reporting and Analysis: Research, compile and consolidate data and conduct preliminary analyses to data collected, and provide progress reports as needed for presentation to stakeholders. Formulate, prepare database and generate preliminary measurement reports for review by PI.
Grants: Prepare and submit grant applications and other grants related activities such as developing grants applications/proposals and fund raising activities if applicable. Collect and organise required paperwork for submission if applicable. Follow up and coordinate resolution of all issues progress reports to the sponsors to fund medical research in the division.
Budget: Develop a preliminary draft budget and submit to the Principal Investigator. Review sponsor-proposed budget for adequate coverage and recommend changes as appropriate. Assist in the preparation of funding reports to funding agencies and help identify new potential sponsors/agents for clinical studies and researches. Monitor budget throughout study.
Human Subjects Research: As applicable, oversee the submission of necessary documents required by the ethics committee, research committee and any other appropriate parties in order to obtain approval to conduct human subjects research (e.g., ensure the update and submission of necessary documents and/or forms to appropriate destination). Might prepare, audit and submit monthly enrolment statistics to the Office of Clinical Trials, and provide other information in timely manner, as necessary
Continuous Learning: Position requires ongoing continuing education in all areas of research development. Promote own professional growth and development in research role and maintain current expertise in area of practice. Maintain a continuing research education, and serve as a resource to peers and work collaboratively with other disciplines within the area of expertise.
Assumption of duties:
- A master's degree in natural sciences or a medical or pharmacy degree with demonstrable research experience
- Two (2) years’ appropriate experience in project or medical research administration, pharmacovigilance or relevant field.
- A driver’s licence, because it involves travelling to the outlying study sites.
- Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications.
- Effective oral, written, communication, interpersonal skills.
- Ability to interface effectively with all levels of management and to work and communicate effectively with both internal and external customers.
- Ability to work within a team environment as well as independently.
- Commitment to continuous learning.
- Ability to work and make decisions independently.
- Time management skills and ability to multi task.
- Ability to identify, analyse and solve problems; and to work well under pressure
- Knowledge of the relevant local African language, the medium of communication to patients.
- A PhD or equivalent in health science field with appropriate experience or knowledge of pharmacovigilance, biostatistics and/or epidemiology.
- Experience in the use of RedCap data base.
- Management experience/degree.
Assumption of duties:
As soon as possible.
Closing date:30 May 2018 Salary: The salary scale is available on request. For any further enquiries, please feel free to contact 051 401 3101 / 2849. General: The University reserves the right not to fill the post. The University subscribes to and applies the principles prescribed by the Employment Equity Act. Preference will be given to candidates from the designated groups, in accordance with the principles of the aforementioned act and the employee profile of the specific department / division.