Study Coordinator Wanted: Mac Staffing Solutions – June 2017


The Study Coordinator will provide administrative oversight for the study and be directly responsible for managing study staff, ensuring that the study is conducted in accordance with the protocol and relevant regulations related to study conduct, informed consent, ethical review, safety monitoring, and recordkeeping. Ensuring the work plan is executed in a timely manner, study targets are met, and all study expenditures are monitored against the study budget.

MAJOR RESPONSIBILITIES: (include but are not limited to the following)

  • Coordinate all aspects of participant screening, enrollment, and retention to ensure study targets are met and study procedures are being conducted per protocol.
  • Oversee, in coordination with the Investigators, all aspects of the study’s clinical procedures to ensure the safety of participants at all times.
    Oversee, in coordination with the Investigators and Lab team, aspects of specimen collection, testing, and results reporting to ensure accurate results and sensitive reporting.
  • Coordinate all aspects of data collection, quality control, reporting, and storage, ensuring that accurate transmission of data occurs in a timely manner.
  • Understanding study indicators and oversee data team responsible for collecting and reporting indicators.
  • Maintain current and develop new monitoring and evaluation systems to ensure optimum study function and quality research data.
  • Develop study Standard Operating Procedures (SOPs) and other study tools in coordination with the Investigators and other study staff.
  • Maintain version control of study informed consent forms and other required study documents.
  • Develop community education, advocacy, and media-related documents, in collaboration with the Investigators, Community Health Educator, and CAB.
  • Prepare study related reports and presentations as necessary for study funders, DHMTs, and other interested parties.
  • Prepare for monitoring visits, follow-up after monitoring visits to ensure required changes and targets are achieved.
  • Report adverse events to the Investigators and to ethics committees, sponsors, and other relevant regulatory bodies as needed in a timely manner.
  • Adhere to the guidelines of Good Clinical Practice and Good Laboratory Clinical Practice at all times.
  • Maintain confidentiality of study data and privacy of participants at all times.
  • Leading study team meetings with all teams involved in the study, ensuring good joint advance planning and monitoring the prompt execution of tasks by the various teams. These teams include Human Resources, Finance, ICT, Procurement, Training, and Data Analysis.
  • Keeping a constantly updated filing system in place for all study activities.
  • Implement study activities according to the protocol and standard operating procedures.
  • Prepare, track, and maintain UNC Institutional Review Board (IRB), UNZA Biomedical Research Ethics
    Committee (BREC), other ethics committee, and Ministry of Health and approvals in collaboration with the Investigators.
    Compile and continually update study regulatory files.
  • Prepare Terms of Reference (TOR) Appraisals, and Performance Management Instruments (PMIs), together with the Investigators, for study personnel and assist in all aspects of the hiring process and ongoing performance review.
  • Oversee coordination, supervision, and training of study personnel.
  • Consult with the Human Resources on all issues affecting staff, including (but not limited to) contracts, leave, benefits and salaries.
  • Ensure Good Clinical Practice (GCP) training, Good Clinical Laboratory Practice (GCLP) and Human Subjects
    Protections (ethics) training of all study staff is up to date as required.

Any other duties or responsibilities found necessary for the successful implementation and functioning of the study.

Budget Management

  • Help provide input for budget preparation and assist the Investigators in preparing study budgets.
  • Monitoring the budget, ensuring study budget is updated from time to time to reflect necessary changes and adjustments, e.g., based on cost increases, savings, or new requirements identified during the course of study implementation.
  • Monitoring expenses against current budget and ensuring program spending remains within budget limits.
  • Working with Finance department to ensure compliance with U.S. government and financial regulations and guidelines.
  • Working together with the administrative support staff, help in preparing project requests to the finance department.

Procurement and Inventory Systems

  • Working together with the study Investigators and administrative support staff, ensure the timely purchase of study supplies/equipment/services and other procurement related activities.
  • Ensuring study supplies are monitored and managed to avoid stock outs.
  • Ensuring a proper inventory system for study supplies and equipment is in place.

Program Reporting and Communication

  • Preparing monthly work plans and budget updates.
  • Preparing reports as required; ensuing accurate reporting, compliance with required formats, and good editing practices.
  • Communicating goals, objectives, and activities clearly and consistently to the study team.
  • Use good communication and interpersonal skills to help facilitate coordination and communication within the study and support teams
  • Collaborate with network/sponsor representatives.
  • Planning internal and external meetings
  • Help resolve disciplinary cases, disputes or disagreements within the study and communicating these with the administrative office and HR department if need arises.

Data Quality Assurance and Quality Control

  • Assisting in standard data quality assurance and quality control of the database, including data and reports.
  • Liaising with staff and data Technician as needed to help manage data omissions or inaccuracies.
  • Conducting direct data entry if needed.

Personnel and Training

  • Liaise with the Administrative and HR department regarding completion and submission of staff time sheets, leave forms, performance appraisals and other required HR activities/documents.
  • Assist in the recruitment and hiring of new study staff when needed.
  • Assisting in the coordination of staff meetings, daily schedules, etc.
  • Complete all required study training, including routine Human Subjects Protection and Good Clinical Practice and Good Laboratory Clinical Practice.
  • Assist in identifying training needs, coordination and implementation of trainings and other programs as necessary to update/ maintain competence of study staff.
  • Build capacity in and provide mentorship to study staff.

SPECIAL SKILLS/COMPETENCES

  • Demonstrated leadership abilities
  • Demonstrated experience in research activities and administrative support functions
  • Must be organized and an independent worker
  • Must have excellent, communication, problem solving, analytical, interpersonal and human relationship skills.
  • Must be proficient in Microsoft programs
  • Able to organize and schedule multiple work-related tasks efficiently

EDUCATION AND EXPERIENCE

  • The job holder must have a minimum of a Bachelor’s Degree in a field related to public health/social work with 5 years’ experience in research activities, with work experience in a reputable NGO
  • Experience coordinating at least one prior HIV research study
  • Minimum experience of two years of community outreach work
  • Experience with international donor projects is preferred
  • Certificate in Management or Supervisory skills is an added advantage

To apply for this job email your details to [email protected]