POSITION LOCATIONS: Remote based in Sub-Saharan Africa
TERMS: Contract (12months)
POSITION REPORTS TO: Clinical Project Manager
ROLE DESCRIPTION:
Guosa Life Sciences is actively recruiting for an experienced Clinical Research Associate I/II to work as an integral part of our global study team in Sub-Saharan Africa. Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include:
- Working independently and proactively to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with ICH-GCP and applicable local regulatory requirements
- Managing sponsor generated queries efficiently and taking responsibility for study cost effectiveness; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required.
- Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
- Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues.
- Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines
- Depending on your level of experience, you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on international projects
- Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
QUALIFICATIIONS & ATTRIBUTES:
- Bachelor’s Degree in Business, Life Sciences, Pharmacy, Nursing or related field of study and/or equivalent experience
- Minimum of 2 years experience in in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment
- Experience across a wide range of clinical indications / therapeutic areas
- A working knowledge of drug development process,ICH-GCP guidelines and local and international regulatory requirements is essential.
- Excellent oral and written communication skills is a must
- Experience in working with global operational teams and the global delivery model across time zones / geographies
- Requires up to 65% of travel
- Fluency in written and spoken English and two other Sub-Saharan African languages
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Guosa Life Sciences HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Guosa Life Sciences may directly contact for employment application
