Rebecca Lenkokile

An ambitious, self-motivated, confident, and hard-working emerging clinical research professional with great passion for serving lives through participation in clinical research.

Experience as Senior Clinical Research Associate in Phase I - III studies, coordinating all the research activities to ensure compliance with South African GCP and ICH GCP guidelines.

Experience in providing overall management and execution of studies as assigned. Acquired skills like communications with PI, sponsor and regulatory authorities and learned to serves as the primary contact in communication and interaction with other departments and clients as applicable Supports and facilitates clinical trials by building strong relationships with trial sites, ensuring efficient study conduct, and accelerating patient enrollment. Act as a bridge between the sponsor company, investigators, and site staff, providing scientific and clinical support to optimize trial performance.

Involved in site selection, investigator recruitment and ongoing site support ensuring that trials are conducted efficiently and in compliance with regulatory requirements. Ensure clear and consistent communication between the sponsor, site personnel, and other stakeholders, addressing queries and concerns promptly. Track key milestones, monitor patient data, and identify potential issues that may impact the trial's progress.

A strong team player, with a strong will to win, ethical and of high integrity demonstrated in my years of experience in the current role, focusing on data and quality. While experience is developing well, the possession of the right attitude, focus on internal/external customers, passion for winning, transparency, accountability and the right skills set I hold are never in doubt. In my years of experience i had the opportunity to fostering strong relationships, facilitating communication, and promoting efficient trial execution, also played a vital role in advancing medical research and bringing new therapies to patients.

Senior Clinical Research Associate at Parexel International SA (2024-10 – Present)

• Identify, select, initiate and closeout appropriate investigational sites for clinical studies.
• Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs applicable regulations and the principles of ICH-GCP.
• Provide a benchmark of monitoring competence to inexperienced/less-experienced colleagues.
• Recognize, exemplify and adhere to ICONs values which center on our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Ability and willingness to travel at least 60% of the time (international and domestic: fly and drive)
• Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations. Familiarity with ICON systems
• Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
• Recruitment of investigators.
• Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following: Identify investigators.
• Help when requested, in preparation of regulatory submissions. Design of patient information sheets and consent forms.
• Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits.
• Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate
• Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets.
• Complete accurate study status reports.
• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
• Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project manager.
• Act as a primary point of contact for sites, addressing queries, providing support, and ensuring that information flows effectively between all parties involved.
• Assist with identifying and evaluating potential trial sites based on their capabilities and experience.
• convey information about the trial to investigators and sites, and also relay feedback and concerns from the sites back to the sponsor.
• Support patient recruitment by working with sites to develop strategies for identifying and enrolling eligible patients in the tria

Clinical Research Associate II at Parexel (2022-07 – 2024-09)

• Identify, select, initiate and closeout appropriate investigational sites for clinical studies.
• Monitor those sites in order to ensure that studies are carried out according to the study Protocol and in accordance with Parexel SOPs/WPs applicable regulations and the principles of ICH-GCP.
• Provide a benchmark of monitoring competence to inexperienced/less-experienced colleagues.
• Recognize, exemplify and adhere to Parexel's values which center on our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Ability and willingness to travel at least 60% of the time (international and domestic: fly and drive).
• Expert knowledge of Parexel's SOPs/WPs, ICH, GCP and appropriate regulations. Familiarity with Parexel systems.
• Maintain timelines. Ensure accuracy and completeness of data entered into Parexel systems. Recruitment of investigators.
• Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following: Identify investigators.
• Help when requested, in preparation of regulatory submissions. Design of patient information sheets and consent forms.
• Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits.
• Conduct regular monitoring visits in accordance with the Parexel site monitoring SOP/sponsor site monitoring SOP, as appropriate.
• Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets.
• Complete accurate study status reports. Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
• Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project manager.

Clinical Research Associate I at Parexel (2021-08 – 2022-06)

• Clinical sites' direct point of contact and accountable for managing site quality and delivery from site identification through close-out.
• Oversee the conduct of the trial at designated sites, ensuring the rights and well-being of human subjects are protected, evaluating the quality and integrity of the reported data, evaluating the site efficacy of staff training ensuring the conduct of the trial follows the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).
• Build relationships with investigators and site staff.
• Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all projects specific training requirements prior to study start.
• Ensure timely and accurate completion of project goals and update of applicable trial management systems.
• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
• Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
• Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Conduct remote visits/contacts as requested/needed.
• Act as Parexel's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
• Review & follow-up site payment status.
• Follow-up on CRF data entry, query status, and SAEs.
• Conduct on-site study-specific training (if applicable).
• Perform site facilities assessments.
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
• Provides administrative and technical support to the Project Team.
• Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's SOPs and department guidance documents.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
• Ensures allocated tasks are performed on time, within budget and to a high-quality standard.

Clinical Trial Coordinator at Wits Reproductive and Health Initiative (2016-02 – 2021-07)

• Provides administrative and technical support to the Project Team.
• Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's SOPs and department guidance documents.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
• Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
• Proactively communicates any risks to project leads.
• Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
• Supports scheduling of client and/or internal meetings.
• Analyses and reconciles study metrics and findings reports.
• Assists with clarification and resolution of findings related to site documentation.
• Supporting CRAs in visit preparation.
• QC of country and site-level documents.
• Performs document tracking in CTMS, verifies appropriate country or site level activity plans are applied, updates country level activities/documents for amendments.
• Compile and distribute Investigator Site File (ISF) and Pharmacy binder to site prior to SIV.
• Review eTMF reports and Preclarus dashboards to identify country and site level essential documents statuses.
• Follow up on outstanding/missing study documents to be sent to site.

Master's in Public Administration – University of South Africa (2017-01 – 2017-01)

Postgraduate Diploma in Public Administration – Regenesys (2010-01 – 2010-01)

Bachelor in Nursing Science – Northwest University (NWU) (2006-01 – 2006-01)