Clinical Research Coordinator

Job Description

Takes on a variety of duties during the course of a study, and these study-related duties are delegated by the Principal Investigator, works closely with the Principal Investigator, providing regular updates on study progress, subject safety, and data management. Supports the execution of clinical trials at the study site, coordinate patient visits, manage study documents, support informed consent, assist with data collection, and ensure the study follows approved protocol and regulatory guidelines.

Key Responsibilities And Duties

• Ensure site compliance with research protocols by reviewing all regulatory requirements and Fakeeh Care Group internal policies to confirm implementation of appropriate practices, and procedures for all research activities.
• Knowledge of clinical research regulations and guidelines, including: Good Clinical Practice (GCP), Human Subjects Protection Regulations, Saudi Food and Drug Authority (SFDA) and Institutional Review Board (IRB) processes and compliance requirements.
• Assist the PI in assessing study feasibility and suitability.
• Review and evaluate the study protocol.
• Contribute to the development of study budgets.
• Maintain ongoing communication with the study sponsor.
• Collaborate with the IRB, office staff, and other department personnel.
• Educate patients and staff on the study protocol.
• Prepare, submit, and maintain necessary regulatory documents (e.g., IRB, FDA).
• Lead site initiation visits to ensure research teams are fully informed regarding the set up and delivery of the trial / study.
• Ability to coordinate multiple concurrent clinical research studies and manage competing priorities while maintaining protocol compliance.
• Monitor and track the study budget, including payments.
• Document study progress, communication, and milestones.
• Record participant study visits and related data.
• Resolve any queries related to study data.
• Provide accurate and timely data collection, documentation, entry and reporting in sponsor Case Report Forms (CRFs).
• Maintain ISF (Investigator Site File) and retain all study records in accordance with sponsor requirements and Fakeeh Care Group policies.
• Coordinate, prepare for, and participate in monitoring visits, audits, and inspections.
• Maintain audit and inspection readiness, ensuring study documents are available for review, and addressing follow-up actions.
• Manage the inventory of equipment and supplies related to the study and order more as needed.
• Close out the study and ensure proper storage of study documentation.
• Interface with research participants to support efforts to determine eligibility and compliance with study inclusion/ exclusion criteria.
• Develop and manage study advertising and recruitment strategies.
• Screen potential participants for eligibility.
• Support the informed consent process and informed consent documentation, ensuring ethical participation and ICH-GCP compliance.
• Schedule and coordinate study visits and assessments.
• Ensure that all tests, procedures, and assessments are conducted according to the study protocol.
• Interview and assess subjects at required time points specified in the protocol.
• Review clinical and laboratory data to identify adverse events.
• Identify, document, report, and follow-up on adverse events as necessary.
• Maintain accountability for the investigational product (drug or device).
• Oversee the storage and administration of study medications.
• Provide documentation to the pharmacy for investigational drug dispensing.
• Coordinate participant reimbursement for study-related activities.
• Provide regular reports and updates to Clinical Trial Unit manager.
• Strong organizational, analytical, and problem-solving skills, with demonstrated ability to manage detailed documentation and maintain data integrity.
• Ability to work onsite in multiple Fakeeh Care Group entities depending on project needs.
• Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts.
• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.
• Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire.
• Occasional travel to attend sponsor study training meetings (required).
• Other duties as assigned within the scope of the job.

All Fakeeh Care employees are responsible for continuous improvement, including:

• Performing all duties and tasks in a manner that supports Fakeeh’s Person-Centered care values.
• Actively contributing to continuous improvement initiatives, within the scope of the role.
• Adherence to safety protocols and proactively seeking to address any job-related safety concerns.
• Maintaining strict confidentiality of all sensitive information accessed or encountered during work.
• Complying with cybersecurity policies and standards to protect Fakeeh’s systems and participating inawareness training and initiatives to prevent cyber threats.
• Adhering to and upholding Fakeeh Care’s code of conduct, policies and ethical standards.
• Completion of mandatory education as per the requirement, at least one month prior to expiration.

Requirements

Skills and Abilities:

• Strong organizational and time-management skills to coordinate multiple study activities.
• Effective interpersonal and communication skills to support cross-functional collaboration with the PI, sponsor, and IRB.
• Working knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Ability to prepare and maintain regulatory and IRB documentation accurately.
• High attention to detail in data documentation and CRF completion.
• Ability to conduct informed consent discussions under the PI’s guidance.
• Skills in participant recruitment and eligibility screening.
• Basic budget tracking and payment documentation skills.
• Ability to recognize, document, and report adverse events per protocol.
• Familiarity with clinical trial management or EDC systems.

Experience

Bachelor’s degree in clinical research administration, Nursing, Public Health, Science, Medical Laboratory Sciences, or related field with clinical research training. Master degree is preferred.

Education

Bachelor’s or master’s degree in clinical research administration, Nursing, Public Health, Science, Medical Laboratory Sciences, or related fields with clinical research training.

Language

Excellent command of oral and written English and Arabic.

Licenses /Certifications

Certification in clinical trial management (e.g., SOCRA or ACRP) is advantageous.