Clinical Project Coordinator

Overview

Clinical Project Coordinator Jobs in Stellenbosch, Western Cape, South Africa at Stellenbosch University

Title: Clinical Project Coordinator

Company: Stellenbosch University

Location: Stellenbosch, Western Cape, South Africa

Department Description/Departement Beskrywing Faculty of Medicine and Health Sciences

Department of Biomedical Sciences

Clinical Project Coordinator

(Post Level 9.1)

(Two-year fixed-term contract)

(Tygerberg Campus)

Ref. TGB02/169/0626

BMRI Clinical Team; Division of Immunology (DOI)

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.

Fakulteit Mediese en Gesondheidswetenskappe

Departement Biomediese Wetenskappe

Kliniese Projekkoördineerder (Posvlak 9.1)

(Tweejaar-vastetermynkontrak)

(Tygerberg-kampus)

Verw. TGB02/169/0626

BMRI Kliniese Span; Afdeling Immunologie (DOI)

Die BMRI Kliniese Span doen kliniese navorsing, insluitend deelnemerswerwing, inskrywing en toestemming. Aktiwiteite sluit in monster- en data-versameling en die uitvoer van alle studiebesoeke en ondersoeke. Die Span doen kliniese proewe sowel as waarnemingstudies en kan bronchoskopieë en die fasilitering en analise van kliniese beeldvorming insluit. Die Span bestuur projekte, insluitend regulatoriese voorleggings en finansiële toesig.

Duties/Pligte

• 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 toepassing), toelaebestuur, finansiële bestuur, openbare gesondheidsentiteite en die Gemeenskapsadviesraad (waar van toepassing).
• 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.

Job Requirements/Pos Vereistes

• 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.

Recommendation/Aanbeveling

• Experience of TB/HIV in the public health sector or research sector.
• A background in laboratory etiquette and a basic knowledge of sample processing.
• Experience in facilitating training and conducting research.
• Ervaring van TB/MIV in die openbare gesondheidsektor of navorsingsektor.
• ‘n Agtergrond in laboratoriumetiket en ‘n basiese kennis van monsterverwerking.
• Ervaring in die fasilitering van opleiding en die uitvoering van navorsing.

How To Apply/Hoe Om Aansoek Te Doen

#PSS

The University is committed to employment equity (EE), and appointments will be made in line with the institutional EE Plan.

Stellenbosch University reserves the right not to make an appointment.

Your application, comprising a comprehensive curriculum vitae (including the names and email addresses of at least three references), must reach the University before or on the closing date in the advertisemen

Apply online at https://www.su.ac.za/en/careers-su by clicking “Apply now” at the top to the right of the page for the specific vacancy.

The University reserves the right to investigate qualifications and conduct background checks on all candidates.

The Occupational Health and Safety Act requires people in occupations that entail potential exposure to certain hazards (such as noise, hazardous chemical substances and hazardous biological agents) to undergo medical screening to determine whether they be fit to work in those occupations.

If you have received no feedback from the University after four to six weeks of the closing date, kindly accept that your application was unsuccessful.

Die Universiteit Stellenbosch is tot gelyke indiensneming (GI) verbind, en aanstellings word ooreenkomstig die institusionele GI-plan gemaak.

Die Universiteit Stellenbosch behou die reg voor om nie ‘n aanstelling te maak nie.

U aansoek moet vergesel wees van ‘n volledige curriculum vitae (met die name en e’posadresse van minstens drie referente) en moet die Universiteit voor of op die sluitingsdatum in die advertensie bereik.

Doen aanlyn by https://www.su.ac.za/af/loopbane-us aansoek deur op ”Apply now” regs boaan die bladsy vir die spesifieke vakature te klik.

Die Universiteit behou die reg voor om kwalifikasies na te gaan en agtergrondinligting oor alle kandidate in te win.

Die Wet op Beroepsgesondheid en Veiligheid vereis dat persone in beroepe met potensiële blootstelling aan sekere gevare (soos geraas, gevaarlike chemiese stowwe en gevaarlike biologiese middels) mediese keuring moet ondergaan om vas te stel of hulle geskik is om in sulke beroepe te werk.

Indien u nie binne vier tot ses weke na die sluitingsdatum van die Universiteit verneem nie, aanvaar asseblief dat u aansoek onsuksesvol was.

Enquiries/Navrae

Enquiries about this post: Mrs Susanne Tonsing on 021 938 9646, or at [email protected]

Enquiries about remuneration/benefits and technical assistance with the electronic application process: Human Resources Client Services Centre, on 021 808 2753 (Stellenbosch), or 021 938 9636 (Tygerberg), or at [email protected]

Navrae oor hierdie pos: Mev. Susanne Tonsing by 021 938 9646, of by [email protected]

Navrae oor vergoeding/voordele en tegniese ondersteuning met die elektroniese aansoekproses: Menslike Hulpbronne Kliëntedienssentrum, by 021 808 2753 (Stellenbosch), of 021 938 9636 (Tygerberg), of by [email protected]

CurrencyZAR Commencement Date01-Sep-2026 Closing Date03-Aug-2026 Amount of Travel Work At Home