Thus, AHRI is seeking to appoint professionals with the following positions.

1.      Research Coordinator (Study coordinator) 

Category: Research and Development

Level: Managerial Level (Study coordinator)

Duration: – One year contract with possible extension

No of Positions: 2

Salary: as Per AHRI scale 

Conducting of Scientific study

• Assists the Principal Investigator (PI) in study of MNTD as requested.

Major role and responsibility

• Reviews and comprehends records and patient information as per the protocol.

• Attends investigator meetings as required or requested by the PI.
• Collaborates with the PIs to prepare reports to partners, stakeholders and any other regulatory submission documents as required as per the protocol.
• Prepares other study materials as requested by the PI. These study materials include, but are 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, Master file, Investigator site file, regulatory binders, study specific source documentations and other materials as requested by PI.

• Reviews and develops a familiarity with the contract or award terms and conditions.
• Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to TSC, DSMB, IRB approval, conflict of interest disclosure, Agreement b/n parties, health and safety protections for participants and staff and any financial terms or conditions.

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections of the research studies.
• Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.

• Collects documents needed to initiate the study and submit to the sponsor including but not limited to Participants insurance documents, Ethical clearance documents, EFDA records, CDA of investigators, CDA of DSMB members, CDA of TSC members, CVs, etc.
• Works with the PI to develop and implement recruitment strategies in accordance with ethics committee’s requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the ECs and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Screens subjects for eligibility as per the research studies protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Registers participants to the appropriate coordinating center as this study is multi-site study (Arbaminch, Bahira Dar, Addiss Ababa and Borumeda) with frequent field visits.
• Coordinates participant sample collection and follow Stanadard operation procedures.
• Transport collected samples from study site to AHRI with respect to SOPs
• Collects data as required by the protocol.
• Assures timely completion of Case Report Forms.
• Maintains study timelines.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol.
• Completes study documentation and maintains study files in accordance with sponsor requirements and AHRI policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Retains all study records in accordance with sponsor requirements and AHRI policies and procedures.
• Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Assists PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and AHRI and sponsoring agency policies and procedures.
• Works with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management.

Reporting

• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within AHRI’s Research Integrity Policy and other misconduct as described in AHRI’s Code of Conduct.
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and AHRI and sponsoring agency policies and procedures.
  Assists in the registration (if required) of the study at PACT and maintains current information on the site.

• Training in programmatic and clinical management of leishmaniasis
• Experience in Research studies research coordination and management

•Experience and knowledge of Data safety management board and Trail Streeting Committees is mandatory

• Trained in GCP or GCLP and quality management system mandatory
• Tolerance to doing routine and frequent field visits
• Attention to details for quality data record and documentation
• Ability to maintain study confidentiality
Personal Attributes:
• Excellent interpersonal communication skill
• Strong organizational skills; volunteer to work off-working hours and/or weekends
• A high level of attention to details
• Open for discussion and learning

• Ability to problem solving and willingness to take self-initiatives
• Willingness to take additional responsibilities and continuous training as needed
• Conduct supervision on overall activities communicating with PI or SC
• Conduct daily check for completeness of ICF, CRFs, AE, SAE, logbooks and other documents
• Ensure eligibility criteria for proper enrollment of study participants
• Involve in recruitment and other duties as deemed necessary by PI

●       CV/resume (not more than 5 pages)

●       A cover letter (not more than one page)

●       A one-page table summarizing your educational background, technical skills and competencies to facilitate the screening process

●       Letter of motivation on how your qualifications, experience and training make you an ideal candidate as well as why you are interested to join and what added value you may bring to the project.

References: Please provide two references including their e-mail addresses and phone numbers.

Remarks: Please attach copies of transcripts, academic degree together with the application