Clinical Trial Coordinator – St. Francis Hospital Nsambya

Job: Clinical Trial Coordinator

Report to: Principal Investigator

Responsible for: Nurses, Records Assistants and Support Staff

Department: Oncology

The Main Purpose of the Job

The Clinical Trail Coordinator (CTC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Although the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CTC synchronizes, supports, and facilitates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CTC works with the PI, the Host Department, sponsor, related institutions and stakeholders to support and provide guidance on the overall administration of compliance, financial, personnel and other related aspects of the clinical study. The CTC reports primarily to the Principal Investigator with associated responsibilities to the Director Clinical Services and Head of Department, Oncology.

General Administration

• Coordinates with PI the general administration functions to ensure that the clinical research and related activities are performed in accordance with protocol, regulations, and sponsoring agency policies and procedures;
• Synchronizes appropriate and timely payments to participants (if applicable) and suppliers, in accordance with set policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the clinical study, around issues related to (but not limited to)  protocol requirements, schedule of visits, execution of research plan, documentation and related issues;
• Supports the PI to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with the protocol, sponsoring agency policies and procedures and best practice;
• Ensures compliance, and monitors efforts related to sponsored program administration and reports instances of noncompliance to the PI; Coordinates and facilitates monitoring and auditing visits and notifies appropriate institutional officials of external audits by the sponsors and Government of Uganda;
• Collaborates with PI and the Hospital to respond to any audit findings and timely implement approved recommendations;
• Cooperates with the sponsoring agency, maintains compliance and monitor efforts related to human research participant protection and reports instances of noncompliance to the PI and appropriate compliance office.

Preparation of Scientific Proposal

• Assists the PI in study feasibility assessments as requested from time to time and document the findings;

Proposal Budget

• Collaborates with the PI and Host Department to prepare a categorized budget and justifications, confirms accuracy and completeness of budgeted costs;

 Protocol Preparation & Review

• Reviews and comprehends the protocol from time to time in collaboration with the PI and the sponsors;
• Attends investigator meetings as required or requested by the PI from time to time;
• Collaborates with the PI to prepare IRB and any other regulatory submission documents as required by the protocol and the Government of Uganda;
• Prepares any 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;
• Coordinates the establishment and organization of study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

Award Acceptance (Terms & Conditions)

• Reviews and develops a familiarity with the contract or award terms and conditions;
• Works with the PI to continuously ensure that study is in compliance with all terms and conditions, including but not limited to IRB approval, conflict of interest disclosure, health and safety protections for participants and staff and any terms or conditions.

Conduct of Research

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assists the PI in communication of study requirements to all individuals involved in the investigations and ensures that there is greater appreciation of the intentions and work system;
• Provides appropriate training and tools for study team members, maintains a training log, which includes but not limited to date of training, name and signatures of study personnel trained, specifics of the training, details of the trainer and any other information deemed important;
• Conducts or participates in the informed consent process including interactions with the IRB 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.
• Sees to it that subjects are screened for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion;
• Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source;
• Coordinates data collection as required by the protocol. Assures timely completion of Case Report Forms;
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Government of Uganda Policy on Investigational Drug/Device Accountability;
• Completes study documentation and maintains study files in accordance with sponsor requirements and 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 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 sponsoring agency policies, procedures and regulations
• 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 in the protocol and other misconduct in the Code of Conduct;
• Assists PI with scientific and compliance reporting requirements in accordance with set regulations and the sponsoring agency policies and procedures.

Project Closeout

• Assists the PI in submission of accurate and timely closeout documents to applicable entities, and the sponsoring agency in accordance with set regulations and the sponsoring agency policies and procedures;
• Responsible for and maintains secure storage of study documents in accordance with the protocol;

 Conflicts of Interest

• Takes appropriate steps to avoid conflicts of interest, or the appearance of conflicts of interest, between financial or other personal interests and the goals and policies of the protocol;
• Complies with applicable regulations and sponsoring agency conflict of interest policies and procedures. Discloses all financial conflicts of interest to the appropriate supervisor.

Human Research Participant Protection

• Assists the PI in protection of the rights and welfare of all human research participants involved in research in accordance with the protocol, sponsoring agency policies and procedures and best practice.
• Supports the PI in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with protocol and best practice. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator to ensure that clinical research and related activities are performed in accordance set procedures.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Cooperates with sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.

Protected Health Information

• Adheres to and supports all regulations, policies and procedures instituted to safeguard Protected Health Information (PHI).
• Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with set regulations and sponsoring agency policies and procedures. Assists PI to assure that all personnel complete appropriate training.
• Cooperates with protocol compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.

Unanticipated Problems

• Assists the PI in promptly reporting any unanticipated problems involving risks to research participants

Export Controls

• Develops awareness of export control regulations of Uganda and complies as appropriate.

Qualifications, Skills and Working Experience: 

1. The applicant should be a holder of Bachelor’s degree in Medicine and Surgery, or Nursing or Social Sciences with a Master’s degree in Public Health, or Epidemiology obtained from a recognized institution of higher learning;
2. At least (02) years post qualification working experience in clinical trials;

 Skills and Competences

• Demonstrates leadership skills
• Coaching and mentoring skills
• Negotiations and Diplomacy skills
• Resilient Practitioner
• Excellent communicator both verbal and written
• Time management skills
• Ability to work as part of a team, as a role model, empowering and motivating other team members.
• Ability to build effective working relationships with Staff
• Ability to work with minimal supervision.
• Shows appropriate professional and personal boundaries.
• Ability to use own initiative, to enable contribution to a multi-disciplinary team.
• Good assertiveness skills.

Terms of Engagement:

 Three (03) Years Employment Contract, renewable, subject to performance.

How to Apply:

All interested and qualified persons should submit the following documents, affixed, in a sealed envelope clearly marked “Application for the Position of Clinical Trial Coordinator”

• Cover letter, describing how you meet the minimum, requirements;
• Updated and detailed Curriculum Vitae/ Resume, with names, contact telephone numbers, and email addresses of three (3) professional referees;
• Copies of Academic Transcript and Certificates;
• Copies of publications, if any;
• Any other information deemed necessary.

Addressed and delivered to:

Human Resources Manager

St. Francis Hospital Nsambya

P.O Box 7146

Kampala, Uganda

Deadline for Submission is Friday, 30 July 2021 at 17:00 hours