Job Description

Key Responsibilities

:

Study Planning & Preparation

: Assist in the development of study protocols, informed consent documents, and other study-related documents. Collaborate with Principal Investigators (PIs) and other clinical staff to ensure the research study is ready for initiation. Ensure that all study materials (e.g., consent forms, case report forms) are organized and accessible.

Participant Recruitment & Retention

: Recruit, screen, and enroll study participants based on inclusion/exclusion criteria. Maintain clear communication with participants throughout the study. Provide participants with detailed study information and obtain informed consent. Address any participant concerns and ensure compliance with study procedures.

Data Collection & Management

: Collect, record, and maintain accurate clinical data as per study protocols. Monitor the progress of the study, ensuring accurate data collection and documentation. Handle study samples (e.g., blood, urine) and ensure proper storage and transport as required. Maintain study-related records in accordance with Good Clinical Practice (GCP) and regulatory standards.

Regulatory Compliance

: Ensure that the study complies with all regulatory requirements, including those set forth by the FDA, IRBs, and other governing bodies. Prepare and submit regulatory documents to IRBs (Institutional Review Boards) and other regulatory agencies. Monitor participant safety and report any adverse events to the PI and regulatory bodies. Keep up-to-date with changes in clinical research regulations and guidelines.

Study Monitoring & Reporting

: Perform regular monitoring of the clinical trial to ensure compliance with the protocol. Report study progress and findings to the Principal Investigator and other stakeholders. Ensure that all study milestones and deadlines are met. Organize and participate in study meetings and site visits.

Budget & Resource Management

: Assist with the management of study budgets, including coordinating the ordering of study supplies and ensuring costs stay within the allocated budget. Ensure proper equipment and resources are available for study procedures.

Safety Monitoring

: Ensure that participant safety is monitored throughout the trial. Report and document any adverse events or unanticipated problems to the appropriate authorities.

Training & Support

: Provide training and guidance to junior staff or new coordinators. Support clinical trial staff with any operational challenges or questions.

Qualifications

:

Education

: Bachelor's degree in a relevant field (e.g., Life Sciences, Nursing, Healthcare)

Skills

: Strong organizational and time-management skills. Excellent written and verbal communication. Ability to work independently as well as part of a team. Knowledge of clinical trial management software (e.g., EDC, CTMS). Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Working Conditions

:

Location

: Clinical research sites, hospitals, academic medical centers, or offices.

Hours

: Typically full-time; may involve evening or weekend work depending on study needs.

Travel

: May require occasional travel to other study sites or regulatory meetings.

Key Attributes

:

Detail-oriented and thorough. Able to work under pressure and meet deadlines. Strong ethical standards and a commitment to participant welfare.
Job Types: Full-time, Permanent

Pay: ?30,086.00 - ?40,006.71 per month

Benefits:

Health insurance Provident Fund
Work Location: In person