Study Coordinator at UNC Global Projects

The University of North Carolina – Global Projects Zambia (UNC-GPZ) is conducting a study to exhaustively document the course and outcomes of labour, delivery, and the immediate postpartum period in settings where the occurrence of adverse birth outcomes is high. The Study Coordinator is directly responsible for managing staff; ensuring the study is conducted in accordance with the protocol and relevant regulations related to study conduct, informed consent, ethical review, safety monitoring, and recordkeeping; and ensuring the project is completed on time and at high quality.

AREAS OF RESPONSIBILITY AND DUTIES

Study Implementation

• Acquire in-depth knowledge of the study and ensuring that the protocol is executed in a timely manner.
• Maintain and develop monitoring and evaluation systems to ensure optimum study function and data quality.
• Coordinate all aspects of participant screening, enrolment, and retention to ensure study targets are met and study procedures are being conducted per protocol.
• Develop and implement study Standard Operating Procedures (SOPs) and other study tools in coordination with Investigators and others and coordinating translations as needed.
• Oversee, in coordination with the Investigators, all aspects of the study’s clinical procedures to ensure safety of participants at all times.
• Oversee, in coordination with the Investigators and laboratory staff, aspects of specimen collection, testing, and results reporting to ensure accurate results and sensitive reporting, including shipping of specimens.
• Develop and implement community/key stakeholder sensitization and engagement plans in collaboration with the Investigators and community staff.
• Identify roadblocks to study implementation and working at all levels to identify solutions to promote full realization of study objectives and activities.
• Consult appropriate supervisors as necessary on any issues related to the accurate and successful implementation of the study.
• Adhere to the guidelines of Good Clinical Practices at all times.
• Maintain confidentiality of study data and privacy of participants at all times.
• Any other duties or responsibilities found necessary for the successful implementation and functioning of the study.

Administrative/Financial Management

• 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, and Data. Write and distribute minutes as needed.
• Provide input for budget preparation in consultation with investigators and Research Managers.
• Working together with the administrative support staff, help in preparing project requests to the finance department as needed.

Regulatory Management

• Coordinate timely submission of reports to the ethics and regulatory authorities.
• Report safety clinical outcomes to IRB/ECs, sponsors and other relevant regulatory bodies as need in collaboration with the Investigator and clinical staff.
• Prepare and maintain study regulatory files.
• Work with external monitors during on-site visits
• Respond to queries from the study team

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.
• Ensure study supplies are monitored and managed to avoid stock outs.
• Ensure a proper inventory system for study supplies and equipment is in place.

Program Reporting and Communication

• Communicate goals, objectives, and activities clearly and consistently to the study team in a timely manner.
• Use good communication and interpersonal skills to help facilitate coordination and communication within the study and support teams.
• Collaborate with network/sponsor representatives.
• Plan internal and external meetings, write and distribute minutes as needed.

Data Quality Assurance and Quality Control

• Coordinate all aspects of data collection, quality control, reporting and storage.
• Ensure accurate transmission of study data occurs in a timely manner in conjunction with data staff.
• Liaise with clinical and data staff as needed to help manage data omissions or inaccuracies.

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.
• Assist in coordination of staff meetings, daily schedules, etc.
• Complete all required study training, including routine Human Subjects Protection and Good Clinical Practice.
• Assist in identifying training needs, in coordination and implementation of trainings and programs as necessary to update/ maintain competence of study staff.
• Build capacity in and provide mentorship to study staff.
• Help resolve disciplinary cases, disputes or disagreements within the study and communicating these with the administrative office and HR department if need arises.

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
• Pays attention to detail

EDUCATION AND EXPERIENCE

• The job holder must have a minimum of a Bachelor’s Degree in Nursing (BSN) or Medicine (MBChB) or in a field related to public health with 5 years of experience in research activities
• Experience with international donor projects is preferred
• Minimum experience of two years of community outreach work
• Certificate in Management or Supervisory skills is an added advantage