Management and Development for Health (MDH) -Employment Opportunites

VACANCY ANNOUNCEMENT

Management and Development for Health (MDH) is a local NGO focusing primarily on public health service and research in the United Republic of Tanzania. MDH is working with WHO Living study team centred at Nairobi to implement a clinical trial titled PROSPECTIVE STUDY OF LOPINAVIR BASED ART FOR HIV INFECTED CHILDREN GLOBALLY. (BRAND NAME: LIVING STUDY). This trial is already ongoing in Uganda and Nairobi. MDH is seeking for two qualified persons to cover the positions of Study Coordinator and a Patients Recruitment Officer who will provide quality inputs in the success of the implementation of this study.

1. Job title: STUDY COORDINATOR (1)

Location: Dar es Salaam

Reports to: Principle/Co Principle Investigator

Job purpose:

The study coordinator will lead the entire implementation of the work plan of the DNDI clinical trial;

coordinating all the activities of the study as indicated in the protocol and in the work plan. Produces narrative reports and contributes to financial reports, for submission to Living Study‐Nairobi. He/ She oversees and manages the rest of the study team, including recruitment officer, study focal persons, data clerks, and is also responsible for supporting the MDH Administrator on tracking and keeping the study related activity spending within the overall planned budget. Will be responsible to coordinate and communicate study activities with in Dar es Salaam and Nairobi DNDI teams. He/she will reports to the Tanzanian Principle Investigator

Duties and Responsibilities:

 Work closely with the Tanzania study PIs, physicians nurses and Co PIs in MDH to implement the

study

 Will coordinate and lead study related activities including communication with DNDI Ifakara and

Nairobi teams as planned

 Facilitate the implementation of the agreed work plan in close collaboration with the PIs participating

health facilities and relevant health departments.

 Organize the training workshops for the study team

 Monitor the budget in collaboration with the finance department at MDH

 Monitor the implementation of clinical trial as per Tanzanian standards and ensure achievement of

the objectives and set targets of recruitment on a timely manner

 Will report on any adverse events timely and follow up on the management, reports to PIs

 Will oversee the implementation of Ethical and regulatory issues handling, for trials (GCP training,

and prior experience of supervising or implementing a clinical trial),

 Will oversee quality Data management and filling of forms appropriately and scanning

 Will provide required reports weekly /monthly.

 Supervise study staff at all the implementing sites

 Responsible for tracking and coordinating renewing NIMR and TFDA approvals each year

 Responsible for coordinating meetings especially onsite meetings as required

 Responsible for reporting and advising on trainings and mentorship needed among the study teams

 Responsible to monitor logistics at site level and coordinate trial and other drug stokes to ensure no

stoke outs of the intended drugs

 Responsible to report the progress and any challenges that are experienced in the field

 Facilitates and coordinates daily clinical trial activities and plays a critical role in the conduct of the

study.

 Schedules study participant appointments and serves as the patient liaison to the PI and other

participating physicians

 Reviews and comprehends each assigned protocol including study proceedings and timelines,

inclusion and exclusion criteria, confidentiality and privacy protections.

 Working closely with the PI, participates in an integral way in the informed consent process by communicating

clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough

knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in

order to be able to answer all questions pertaining to the study posed during the informed consent process.

 Completes case report forms. Extracts data from patient charts in a timely manner

 Responds to data clarification requests in a timely manner.

 May attend Investigator meetings requiring travel and report pertinent information back to research team

members.

 Coordinates with PIs and department to help ensure that clinical research and related activities are

performed in accordance with protocols.

 Maintains subject screening logs and protocol deviation logs.

 Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials.

 Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external

audits by IRB’s, Regulatory agencies, CRO’s and sponsors.

 Completes documentation on each study visit that is used to track all study related activities so that time,

effort and materials can be accounted for on a monthly basis.

 Ensures that all materials for each clinical trial protocol are available for subject enrollment.

 Works collaboratively with the other members of the clinical research team and the clinical and administrative

support teams to ensure all protocols are followed and that there is timely documentation and submission of

study data.

 Performs specimen processing and shipment of biological specimen duties.

 Ensure availability of current versions of study materials including but not limited to, the informed consent

document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.

 Establishes and organizes study files, including but not limited to, regulatory binders, study specific source

documentation and other materials as required.

 Arranges secure storage of study documents that will be maintained according to institutional policy or for the

contracted length of time, whichever is longer.

 May perform other job related duties as requested or required.

REQUIREMENTS:

Educational and Professional qualifications:

 Medical Doctor

 Master in Public Health

Practical Experience:

 HIV care and Treatment especially to children

 Clinical trials or Research among people living with HIV

Other Skills:

 Data collection

 Report writing

2. Job Position: PATIENTS RECRUITMENT OFFICER (1)

Location: Dar es Salaam

Reports to: STUDY COORDINATOR

Job purpose:

The Patients Recruitment officer will facilitate identification and hiring of patients needed for this clinical

trial through working closely with the targeted sites health care workers to identify potential eligible

patients and channel/recruit the patients into the study. He/she will report to the study coordinator.

Duties and Responsibilities:

 Work closely with the sites focal persons and the study coordinator

 Identify eligible participants from each sites and channel them to /recruit them into the study after

providing informed consent

 Provide Information to the sites health care workers and the patients about the study and how to join

 To facilitate recruitment of sufficient number of patients per site as targeted/indicated in the study

proposal

 Coordinate formal referrals patients who are eligible to the Temeke for the study activities and

monitor logistics required for patients and providers

 Communicate any adverse events to site focal, study coordinator and paediatrician for quick

management

 Provide feedback on the progress of recruitment and any challenges that might hinder timely reach

of recruitment targets

 Attend study meetings and provide weekly/monthly recruitment progress reports

 Work with the sites team to scan documents that will be required to Nairobi DNDI team

 Perform any other job related duties as requested by the supervisor.

REQUIREMENTS:

Educational and Professional Qualifications:

 Nursing Officer

Practical Experience:

 HIV care and treatment especially to children

 Clinical Research or research recruitment of patients

Other Skills

 Data collection

 Report writing

TO APPLY:

Interested candidates should submit an application letter indicating the position applied for, a detailed

copy of their CV and contact information (email addresses and telephone numbers) of three work related

referees by 27th June 2017, to the Senior Human Resource Manager through e‐mail hr@mdh‐tz.org or

dropped by hand at the MDH Head Office in Mikocheni, along Mwai Kibaki Road, Plot No. 802.

Kindly note that only shortlisted applicants will be contacted.