Study Coordinator
at Stellenbosch University
Stellenbosch, Western Cape, South Africa -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 05 Oct, 2024 | Not Specified | 06 Jul, 2024 | 2 year(s) or above | Clinical Trials,English,Interpersonal Skills,Regulatory Requirements,Quality Assurance Processes,Protocol,Powerpoint,Health,Computer Skills,Communication Skills,Excel,Children,Teams | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Duties/Pligte
- Administrative
- Serving as a liaison to Sponsor/CRO/Regulatory Authorities/Investigators;
- Participating in team meetings and conference calls with the Principal Investigator (PI) and sub-investigators for the different protocols, and taking and circulating minutes;
- Setting up unit and study team meetings as required;
- Providing support to the clinical team, thereby ensuring continuity of service and problem resolution;
- Ensuring that study specific and general training is done for all (new) staff and for amendments;
- Ensuring that all study material is correctly archived after study close-out visits;
- Retaining documentation of vendor qualifications;
- Effective operations and delivery of site activation deliverables within the assigned study.
- Facility oversight
- Identifying and ordering all supplies needed for the studies, and ensuring that they are available for the execution of the study in collaboration with relevant site administrative personnel;
- Overseeing that all equipment is calibrated at least once a year, or as per product / sponsor guidelines;
- Overseeing maintenance of all clinical and laboratory equipment in collaboration with the laboratory group;
- Overseeing monthly check of emergency trolley and after use in the event of an emergency;
- Ensuring that the necessary temperature monitoring is in place for all relevant items, including but not limited to IP and laboratory kits.
- Regulatory
- Engaging with internal and external stakeholders as appropriate, including, but not limited to, SAHPRA, USHREC, NHREC, DOH, CCT, TBH and any other regulatory authority as determined by the study/sponsor;
- Maintaining up-to-date knowledge of the relevant ethics committee, SAHPRA and external stakeholders regulations;
- Compiling and submitting submission documents and reports to the ethics committee, SAHPRA and external stakeholders according to their guidelines, SOPs and timelines;
- Submitting AEs, EAEs, SAEs, safety reports, protocol deviations and CAPAs, etc., as per the ethics committee and SAHPRA guidelines, SOPs and timelines.
- Quality control and quality assurance
- Ensuring that knowledge of quality control and quality assurance processes is compliant with trial and site requirements (SOPs);
- Implementing, maintaining and updating current quality assurance processes;
- Assessing status of quality at site.
- Clinical operations / study start-up / activation
- Acquiring and maintaining in-depth knowledge of the protocol and its amendments, and guiding documents such as the Manual of Operations (MOP), Study Specific Procedures Manual (SSP) and site specific standard operating procedures;
- Being up to date with all aspects of the trial - enrolment, retention, major deviations, etc.;
- Organising training sessions for study staff. Developing training slides or practical training sessions;
- Developing and maintaining ISF throughout the trial, from study start-up until study close-out;
- Developing and maintaining source documentation that satisfy the information needed for completing the CRFs;
- Developing CRF templates based on the requirements of the protocol (if indicated);
- Pro-actively identifying risk factors / challenges for studies and research sites. Developing and implementing contingency plans with the multidisciplinary team;
- Ensuring that general and study-specific processes comply with the protocol, the MOP and with standard operating procedures (SOPs). Adhering to GCP and regulatory requirements (local and international);
- Completing quality control and quality assurance procedures;
- Setting recruitment goals and timelines in collaboration with the PI and site personnel, and developing recruitment plans and strategies;
- Preparing for monitoring visits and serving as contact person for monitors during the visit;
- Managing relevant members of the research team on-site: training, delegating and coordinating staff;
- Liaising closely with clinical, regulatory, admin, laboratory, pharmacy, data and other relevant teams.
- DAIDS / other networks / grant funded studies
- Informing the clinical research site coordinator of any changes in the site operations;
- Preparing required documents for trial network submission in a timely manner;
- Timely review and submission of CSM findings to the regulatory team.
- Finances
- Assisting with monthly billing verification of visits completed at site, and providing feedback to the PI.
Job Requirements/Pos Vereistes
- A tertiary qualification in nursing, or a B-degree in medical science or a related field;
- Active registration with SANC/HPCSA (if applicable);
- At least three years’ experience working with IMPAACT, ACTG or TBTC network, or other clinical TB therapeutic trials involving investigational products;
- At least two years’ experience working as a study coordinator on TB, or TB and HIV, or other infectious disease related randomised clinical trials in children and/or adults involving an investigational product;
- Actively coordinating at least two clinical trials (one being a randomised clinical trial) as a study coordinator;
- Experience in quality control and quality assurance processes;
- In-depth knowledge of compiling documents and making submissions to SAHPRA, the ethics committee, the Departement of Health, the City of Cape Town, and other health authorities;
- The ability to work accurately according to protocol and related documents, SOPs and regulatory requirements;
- The ability to work independently, or in a team environment as a member of an interdisciplinary team;
- Sound interpersonal skills;
- Strong organisation and prioritisation skills;
- Excellent written and verbal communication skills in English;
- The skills to solve problems independently and effectively;
- A goal-oriented disposition;
- Excellent computer skills in MS Word, PowerPoint, Excel and Teams;
- A valid driver’s licence and own transport.
Recommendation/Aanbeveling
- Knowledge of national and international regulatory requirements;
- Experience of performing quality assurance and regulatory functions for clinical trials, preferably on infectious diseases (TB and HIV in particular);
- Experience of community-based clinical research on TB, or on TB and HIV;
- Experience of working with industry sponsored pharmaceutical trials will be advantageous;
- Additional language skills in Afrikaans, isiXhosa or isiZulu (or more than one of these languages).
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:2.0Max:7.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
A tertiary qualification in nursing or a b-degree in medical science or a related field;
Proficient
1
Stellenbosch, Western Cape, South Africa