Clinical Trial Investigator and Coordinator

4 months ago

Stellenbosch, South Africa Stellenbosch University Full time

Duties/Pligte
- Directing research site operations by ensuring that all research staff are trained on and informed about SOPs;
- Ensuring that appropriate and optimal human and operational resources are in place for the ethical and efficient conduct of all trials;
- Overseeing the administrative tasks and requirements of the Unit;
- Together with the director, Centre manager and human resources administrator, ensuring that staff are familiar with their role and responsibilities, job requirements and expectations and that they have agreed to their current job descriptions;
- Providing clinical support to PI's, sub-investigators, study coordinators, sisters, study nurses and supporting teams;
- Providing operational support to the pharmacy, specimen processing and data teams;
- Acting as a liaison with other managers to assess staff allocation and identify team members available for potential studies;
- Establishing, training, and overseeing an IPC team, to identify, monitor and report IPC challenges and areas of concern;
- Expanding the FAMCRU academic footprint by ensuring sound academic outputs through personal work and mentored work;
- Providing regulatory support to and overseeing the project managers and study coordinators to ensure compliance with reporting requirements;
- Providing support to and overseeing the quality assurance manager;
- Overseeing and managing the design and maintenance of a Unit source document template and standardised clinical logs to be used for all studies;
- Providing operational support to the director.
- Lei navorsingsaktiwiteite deur te verseker dat alle navorsingspersoneel opgelei en ingelig is oor SOP's;
- Verseker dat toepaslike en optimale menslike en operasionele hulpbronne in plek is vir die etiese en doeltreffende uitvoering van alle proewe;
- Toesighouding oor die Eenheid se administratiewe take en vereistes;
- Maak saam met die direkteur, sentrumbestuurder en menslikehulpbronadministrateur seker dat personeel vertroud is met hul rol en verantwoordelikhede, posvereistes en verwagtinge en dat hulle tot hul huidige posbeskrywings ingestem het;
- Verskaf kliniese ondersteuning aan PI's, sub-ondersoekers, studiekoördineerders, susters, studieverpleegkundiges en ondersteunende spanne;
- Bied operasionele ondersteuning aan die apteek, monsterverwerking
- en dataspanne;
- Tree op as 'n skakel met ander bestuurders om personeeltoewysing te assesseer en spanlede te identifiseer wat beskikbaar is vir potensiële studies;
- Vestig, lei op en hou toesig oor 'n IPC-span om IPC-uitdagings en -areas te identifiseer, te monitor en aan te meld;
- Uitbreiding van FAMCRU se akademiese voetspoor deur goeie akademiese uitsette deur persoonlike werk en mentorwerk te verseker;
- Bied regulerende ondersteuning aan en hou toesig oor die projekbestuurders en studiekoördineerders om nakoming van verslagdoeningsvereistes te verseker;
- Bied ondersteuning aan en toesighouding oor die gehalteversekeringsbestuurder;
- Toesighouding oor en bestuur die ontwerp en instandhouding van 'n Eenheidsbrondokumentstemplaat en gestandaardiseerde kliniese logboeke wat vir alle studies gebruik moet word;
- Verskaf operasionele ondersteuning aan die direkteur.

Job Requirements/Pos Vereistes
- A medical doctor's degree;
- Registered to practice in South Africa;
- HIV management and infectious diseases experience;
- At least five years' research experience;
- Previous PI experience;
- Experience in general project management in a large and complex environment;
- A valid driver's licence.
- 'n Mediese doktersgraad;
- Geregistreer om in Suid-Afrika te praktiseer;
- Ervaring van MIV-bestuur en aansteeklike siektes;
- Minstens vyf jaar se navorsingservaring;
- Vorige PI ervaring;
- Ervaring in algemene projekbestuur in 'n groot en komplekse omgewing;
- 'n Geldige rybewys.

Recommendation/Aanbeveling
- A physician/paediatric specialist;
- Valid GCP will be advantageous;
- The ability to deal with multiple simultaneous demands in a high pressure environment;
- Excellent clinical management skills;
- Strong analytical and problem-solving skills;
- Effective communication skills;
- Sensitivity to cultural differences;
- Good understanding of political, confidential, and ethical issues surrounding HIV infection and other infectious diseases;
- Effective planning and scheduling skills;
- The ability to integrate the resources (people, material, information, budget, time) required to accomplish goals;
- The ability to be creative and innovative, to promote new ideas and to develop new or improved processes, methods, systems, solutions, products or services;
- The ability to build partnerships and to collaborate with and lead a team.
- 'n Geneesheer/pediatriese spesialis;
- Geldige GCP sal voordelig wees;
- Die vermoë om verskeie gelyktydige eise in 'n hoëdrukomgewing te hanteer;
- Uitstekende kliniese bestuursvaardighede;
- Sterk analitiese en probleemoplossingsvaardighede;
- Effektiewe kommunikasievaardighede;
- Sens

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