Clinical Project Coordinator

Department Description / Departement Beskrywing

Fakulteit Mediese en Gesondheidswetenskappe

Faculty of Medicine and Health Sciences

Department of Biomedical Sciences

Clinical Project Coordinator

Post Level 9.1

(Two-year fixed-term contract)

(Tygerberg Campus)

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TGB
02/169/0626

The BMRI Clinical Team conducts clinical research, including participant recruitment, enrolment and consenting. Activities include sample and data collection, conducting all study visits and investigations. The Team conducts clinical trials as well as observational studies, and can include performing bronchoscopies and facilitating and analysing clinical imaging. The Team manages projects, including regulatory submissions and financial oversight.

• Coordinating clinical research studies/trials, ensuring effective and efficient operations, ensuring quality assurance, compliance with regulatory stipulations and with study protocol.
• Coordinating contracting and regulatory applications (SAHPRA, IRB, etc.) and approvals for research studies.
• Assisting with budgeting and tracking expenditure and invoices on projects.
• Assisting with planning and implementing new studies.
• Coordinating the upkeep of the `Investigator Site File as well as other study-specific documentation
• Overseeing procedure scheduling, as well as sample collection and flow.
• Communicating with all study sites, sponsor(s), funders and regulatory authorities, as well as during operational meetings and conference calls.
• Communicating regularly with all members of the core team about study progress and changes, including representatives from the lab, scientists, data and database management, statisticians, quality control, internal and external monitors, and clinical staff.
• Also liaising with study recruiters, pharmacy (if applicable), grants management, financial management, public health entities, and the Community Advisory Board (when applicable).
• Central coordination of studies across study sites as sponsor.
• Performing various administrative tasks related to studies, including drafting study-related documents, standard operating procedures, as well as regulatory and funder reports.
• Line managerial duties.
• Koördineer kliniese navorsingstudies/-proewe en verseker effektiewe en doeltreffende bedrywighede, insluitend gehalteversekering, nakoming van regulatoriese vereistes en studieprotokolle.
• Koördineer kontraktering en regulatoriese aansoeke (SAHPRA, IRB, ens.) vir navorsingstudies.
• Hulpverlening met die opstel van begrotings en hou tred met uitgawes en fakture.
• Hulpverlening met beplanning en implementering van nuwe studies.
• Koördineer die instandhouding van die `Investigator Site File sowel as ander studiespesifieke dokumentasie.
• Oorsien prosedureskedulering, asook die versameling en vloei van monsters.
• Kommunikeer met alle navorsingspersele, borg(e), finansiers en regulatoriese owerhede, asook tydens operasionele vergaderings en konferensie-oproepe.
• Kommunikeer gereeld met alle lede van die kernspan oor studievordering en veranderinge, insluitend verteenwoordigers van die laboratorium, wetenskaplikes, data- en databasisbestuur, statistici, gehaltebeheer, interne en eksterne moniteerders, en kliniese personeel.
• Skakel ook met studiewerwers, die apteek (waar van toe passing), toelaebestuur, finansiële bestuur, openbare gesondheidsentiteite en die Gemeenskapsadviesraad (waar van toe passing).
• Sentrale koördinering van studies oor verskeie navorsingspersele, as borg.
• Verrig verskeie administratiewe take wat met studies verband hou, insluitend die opstel van studieverwante dokumente, standaardbedryfsprosedures, asook regulatoriese en finansieringsverslae.
• Lynbestuursverantwoordelikhede.

• Either have a master's degree (in the field of medicine, health or social sciences, or relevant alternative), or be a registered nurse.
• At least five years experience in coordinating clinical research.
• A valid driver's licence.
• Well-versed in GCP.
• A valid good clinical practice (GCP) certificate.
• Excellent written and verbal communication skills.
• The ability to solve problems independently and effectively. Attention to detail.
• A goal-oriented disposition.
• Computer literacy (Microsoft Office Suite, database and portal interactions).
• Sound interpersonal skills.
• Of 'n Meestersgraad (in die veld van geneeskunde, gesondheid of sosiale wetenskappe, of 'n toepaslike alternatiewe kwalifikasie), of registrasie as 'n verpleegkundige.
• Minstens vyf jaar se ervaring in die koördinering van kliniese navorsing.
• 'n Geldige rybewys.
• Bekwaam in Goeie Kliniese Praktyk (GCP).
• 'n Geldige sertifikaat in Goeie Kliniese Praktyk (GCP).
• Uitstekende skriftelike en mondelinge kommunikasievaardighede.
• Die vermoë om probleme onafhanklik en doeltreffend op te los.
• Aandag aan detail.
• 'n Doelgerigte ingesteldheid.
• Rekenaargeletterdheid (Microsoft Office Suite, databasis en aanlyn portaalinteraksies).
• Goeie interpersoonlike vaardighede.

• Experience of TB/HIV in the public health sector or research sector.
• A…