Junior or Senior Clinical Research Associates
Positions can be based in Cape Town or Pretoria/Johannesburg and can potentially be home- or office based.
Conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- May provide assistance to more less experienced clinical staff.
How much travelling is involved? Approximately 60% although we try to limit it. It also depends on the study – some have more travelling involved than others.
Therapeutic areas involved:TB, Diabetes, Rheumatoid Arthritis, Oncology, Cardiovascular, Flu, Osteo, HIV etc.
Which business units? Clin Ops and GFR (sponsor dedicated unit)
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- In depth therapeutic and protocol knowledge as provided in company training
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a lap top computer
- Strong written and verbal communication skills including good command of English language
- Excellent organizational and problem-solving skills
- Effective time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
Bachelor's degree in a health care or other scientific discipline or educational equivalent and more than 1 year of on-site monitoring experience; or equivalent combination of education, training and experience
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Frequent travel to sites, primarily domestic, may include international travel