Curriculum Vitae

Of

Sibongile Beverly Koshane

Personal Details

Surname : Koshane

First Names : Sibongile Beverly

Identity Number : 731***-****-***

Nationality : South African

Gender : Female

Drivers License : Code: 8/B

Marital Status : Single

Contact Details : 072-***-****/ 012-***-****

Email Address : acrmm6@r.postjobfree.com

acrmm6@r.postjobfree.com

Home Language : Northern Sotho

Other Language : English Afrikaans Zulu

Speak : Good Fair Good

Read : Good Fair Good

Write : Good Fair Good

Residential Address : 2988 Block L

Soshanguve, 0152

Postal Address : Same as above

Secondary Education

School Attended : Reitumetse Secondary School

Grade Passed : Grade 12 (completed- 1994)

Subject Passed : Tswana First Language

- English Second Language

- Afrikaans Third Language

- Economics and Business Economics

Other Qualification

Name of Institution : Havatech (S-TECH) Computer College

Qualification : Computer Literacy (MS Word, Excel,

Power Point and office admin

Year Completed : 2005

Additional Database Trainings (certification)

_Clinical Data Management (Acro)

- Clintrial/ Citrix (Regional Data Entry Training)/ FHI -Research Ethics Curriculum(FHI) -Good Clinical Practice (GCP)/FHI(family health international) -Clinical and socio-Behavioral and community core training(FHI)

-Good Participatory Practice/WRHI, FACTS(follow-on African consortium for Tenofovir studies)

-Clindex (OnQ data)

-OC-RDC (Pfizer)

-Inform 4.6/5.5 and Viedoc

-Medidata Rave (Amgen study and Biogen study)

Knowledge, skills and Interpersonal Abilities

- Able to work well in a team,

- self management and confident in handling new tasks.

- Flexible in assignment,attention to detail, able to work under tight deadlines with less

supervision.

- Good understanding of clinical drug development process

- Excellent organizational, communication and data management skills (detail oriented)

- Ability to establish and maintain effective working relationships with coworkers, managers and

Clients.

Clinical Trials:

A process in conducting a scientific study of how a new medicine or treatment works in people. Through clinical studies, doctors find new and better ways to prevent, detect, diagnose, control, and treat illnesses.

Many new medicines and treatments are found to be helpful and safe in test tubes and in animals. They must also prove safe and effective in humans before doctors can prescribe them. This testing in humans is permitted only if that person volunteers for participation and understands the risks and benefits of taking part in a study. This informed consent to participate must be based on the volunteer's understanding of what is involved in the study, including potential risks and benefits. Volunteers may leave a study at any time.

EMPLOYMENY HISTORY

1.Organization : Quintiles

Position held : Senior Clinical Data Coordinator(CDC)

Period worked : 01/Nov/2014- To date

Job Description : -Serve as a data operation coordinator(DOC) for one or two

global studies with fewer than 10 operation staff(excludes DE)

or in a leader ship role to a specific Data Management task.

-Manage delivery of projects through full data management

study life-cycle (with minimal guidelines)

-With guidelines from DTL or manager, manage project

timelines and quality, determine resources needs, identify

out-of scope work.

-Perform comprehensive data management task including data

review, writing and resolving data clarification.

-Perform database designer activities for technologies not

requiring extensive programming.

-Perform comprehensive quality control procedures.

-Independently bring projects solutions to the clinical management team

-Solve issues through using global issue escalation and

communication plan

-Consult with standards Group for process issues, communicate

ideas for process improvement.

-Assist in developing and implementing new technology

-Understands and comply with core operating procedures and

working instructions. Meet objectives as assigned.

-Develop and maintain good communication and working relationship

with clinical data management team.

-Interact with clinical data management team members to negotiate

timelines and responsibilities.

2.Organization : SYNEXUS-SA CLINICAL RESEARCH

Position Held : Data Coordinator/Capturer and Archiving

Period Worked : 01/June/2012- 30/Oct/2014

Job Description : -Ensure correct data was extracted, assures quality and accuracy

of source and CRF documentation prior to entry.

-Quality control of informed consent process on multiple studies.

-Collect and transcribe data from source documents to paper

CRF/e-CRF

-Implementation of COP’s and SOP’s, ensure commercial

success of the centre by providing procedural and logistical

support to the clinical team and ensuring protocol and GCP

regulatory compliance .

-Liaison with clinical staff to complete correction promptly and

timely.

-Receive queries, respond, escalate and follow up on responses.

-Complies with quality management (QM) guidelines and perform

corrections for QM, CRC and monitor/sponsor representatives in

timely manner.

-Retrieving of/or filling of files, and maintaining an efficient system

- Archiving of files and study documentation.

- Review 100% of informed consent as per GCP, review

implementation of study procedural documentation and SOP’s.

-Assist project team before, during and after the external review

to address corrective and preventative action of queries and

prepare for audits and monitoring.

-Work with data team and review trend based on quality reports

during quality assurance activities.

3.Organization : SETSHABA RESEARCH CENTRE

Period Worked : 01/May/2009 -31/May/2012

Position Held : Data Capturer, Quality Assurance Officer

and Information session officer

Job Description : -Collecting, capture, verify and reconciling of source documents

into a specific database according to specific guidelines.

-Adhere to all data management guidelines and confidentiality

agreements.

-Quality control: Tracking of source documents received in-house

and review prior to capturing, data faxing within the required time

for completeness, accuracy and consistence.

-Disseminating lab results to doctors for transcribing prior to

capturing and filling.

-Assist department with responding to queries from data cleaning,

data faxing and any other duties called on to perform for the

efficient running of the department.

-Health information sessions: To outline the study information to

potential subjects and stakeholders on how the study works,

inclusions, exclusions criteria’s,the design of the study, the

purpose, procedures and the duration of the study.

-Explanation on trial related issues :care,management of

infectious diseases, nutritional health, psychological care and

psychosocial services.

-Explanations on risk assessment and risk reduction counseling

including partner and couple counseling, male and female

condoms with appropriate instructions and demonstrations,

testing for and treatment of sexual transmitted infections

Reason for Leaving : Resigned

4.Organization : Standard Bank South Africa

Position Held : Customer Care officer/Confirmation clerk

Period Worked : 1997-2001

Job Description : -Resolve all customer queries with regard to:

information relating to transaction on account, bank

charges, debit orders, stop payments, electronic account-

payments, audit certificates and certificate of balance,

capture statistics,coding and administration, liaising with

service providers regarding authorization and any other

duties assigned for.

Reason for Leaving :Contract Basis

References

1.Melanie Rapson : Manager(Global data and safety monitoring)

Relationship : Data Manager

Telephone : 012-***-**** / 076-***-****

Email : acrmm6@r.postjobfree.com

2. Refilwe Bokaba : Synexus-SA Clinical Research

Relationship : Site Manager

Tel : 012-***-****/083-***-****/082-***-****

Email : acrmm6@r.postjobfree.com

3. Buskien Mohale : Setshaba Research Centre

Relationship : Data Manager

Tel : 012-***-****/073-***-****

Email : acrmm6@r.postjobfree.com

4. Phillis Lees : Standard Bank

Relationship : Team Leader

Tel : 012-***-****/086*-***-***

Contact this candidate