Study Coordinator at Part of the Mac Holdings Group

The Study Coordinator will provide all administrative oversight for the study and is directly responsible for managing staff, ensuring the work plan is executed in a timely manner, study targets are met, and monitoring all expenditures against the study budget.

AREAS OF RESPONSIBILITY AND DUTIES (include but are not limited to the following)

Clinical Activities

• Conduct study procedures and adhere to procedural and international guidelines for research conduct.
• Screen and enroll eligible study participants.
• Recruit and retain participants.
• Obtain participant locator information.
• Obtain informed consent.
• Perform detailed medical histories and thorough physical exams on participants and assess for and report any and all adverse events and concomitant medications.
• Collect data.
• Collect specimens.
• Review and interpret test results.
• Provide participant care and management per study-specific and Zambian guidelines in consultation with the Medical Officer/Investigator.
• Complete study-specific and non-study-specific prescriptions appropriately.
• Provide appropriate referrals to the Medical Officer/Investigator, District Clinic, or Hospital as required.
• Performing self-quality checks (QC) in a timely manner.

Study Implementation

• Acquire in-depth knowledge of the study approach and work plan and ensure that the work plan is executed in a timely manner.
• aintain and update the study work plan so that it accurately documents:
  1) all current study objectives and activities, and
  2) actual progress in conducting activities against targeted dates.
• Lead study team meetings with all teams involved in the study, ensuring good joint advance planning and monitoring prompt execution of tasks by the various teams. These teams include Human Resources, Finance, ICT, Procurement, Training, and Data Analysis.
• Oversee, in coordination with the Investigator and study staff, all issues of participant screening, enrolment, and retention to ensure study targets are met and study procedures are being conducted per protocol.
• Identify roadblocks to planned work plan activities and work at all levels to identify solutions to promote full realization of study objectives and activities.
• Understand study indicators and oversee data team responsible for collecting and reporting indicators.

TOR – Study Coordinator 1

TERMS OF REFERENCE TITLE – Study Coordinator

REPORTS TO – Study Investigator of Record LOCATION – Lusaka

• Monitor indicators on a monthly basis and use results to adjust current work plan and inform future planning.
• Assist in timely submission of reports to the UNC IRB and UNZA BREC.
• Report safety clinical outcomes to IRB/ECs, sponsors and other relevant regulatory bodies as need in collaboration with the Investigator and clinical staff.
• Consult appropriate supervisors as necessary on any issues related to the accurate and successful implementation of the study.
• Organize the logistical aspects of the focus groups, interviews with stakeholders and key informants and discrete populations.
• Assist in the development and implementation of study Standard Operating Procedures.
• Keep a constant updated filing system in place for all study activities.
• Follow and adhere to the guidelines of Good Clinical Practices at all times.
• Maintain confidentiality of study data and privacy of participants at all times.
• Maintain blinding of study staff as needed.

Budget Management

• Help provide input for budget preparation.
• Monitor 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.
• Monitor expenses against current budget and ensuring program spending remains within budget limits.
• Work with the Finance department to ensure compliance with U.S. government and financial regulations and guidelines.
• Work together with the administrative support staff, help in preparing project requests to the finance department.

Program Reporting and Communication

• Prepare monthly work plans and budget updates.
• Prepare reports as required; ensuring accurate reporting, compliance with required formats, and good editing practices.
• Communicate 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
• Plan internal and external meetings, writes minutes, and sending them out for distribution.
• Help resolve disciplinary cases, disputes or disagreements within the study and communicating these with the administrative office and HR department if need arises.

Procurement and Inventory Systems

• Work together with the study investigators and administrative support staff, ensure the timely purchase of study supplies/equipment/services and other procurement related activities.
• Ensure study supplies are monitored and managed to avoid stock outs
• Ensure a proper inventory system for study supplies and equipment is in place
  Data Quality Assurance and Quality Control
• Assist in standard data quality assurance and quality control of the database, including data and reports.
• Liaise with staff and data associates as needed to help manage data omissions or inaccuracies.

TOR – Study Coordinator 2

• Conduct 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 of new study staff when needed.
• Assist in coordination of staff meetings, daily schedules, etc.
• Assist in coordination and implementation of trainings and other workshops
• Identify training needs and organize training programs as necessary to update/ maintain competence of study staff.
• Complete all required study training, including routine Human Subjects Protection and Good Clinical Practices training, and regularly attend study meetings.

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 Bachelors Degree in a field related to public health/social
• At least 3 years’ clinical experience in adolescent and women’s health, including family planning, HIV prevention and treatment, STI prevention and treatment, and cervical cancer prevention
• Active registration with the Health Professions Council of Zambia
• Minimum experience of five years of team/program management work
• Familiarity with the Cervical Cancer Prevention Program in Zambia