Clinical Research Coordinator ( Male)

responsible for managing the day-to-day activities of clinical trials to ensure they adhere to strict protocols, ethical standards, and regulatory guidelines such as Good Clinical Practice (GCP)

• Participant Management:

  Recruit, screen, and enroll eligible participants; obtain and document informed consent; schedule study visits; and monitor participant well-being and adherence to the study protocol.

• Data Management:

  Collect, record, and manage study data on source documents and Case Report Forms (CRFs) or electronic data capture (EDC) systems; perform quality checks; and resolve data queries in a timely manner.

• Regulatory Compliance:

  Prepare, submit, and maintain all study documentation for the Institutional Review Board (IRB) or Ethics Committee and other regulatory agencies (e.g., FDA); report adverse events and protocol deviations promptly.

• Study Coordination:

  Act as the primary liaison between the PI, sponsors, Contract Research Organizations (CROs), and other study vendors; coordinate monitor visits and audits; and ensure all equipment and supplies are in stock and in working order.

• Clinical Procedures:

  Perform basic clinical procedures such as taking vital signs, performing ECGs, and collecting and processing lab specimens, if certified and/or delegated by the PI.

• Financial Management:

  Assist with budget preparation, track expenses, and ensure timely payment of study-related fees and participant reimbursements.

Required Qualifications and Skills

• Education:

  A bachelor's degree in a health science, life science, nursing, or a related field is typically required. Some positions may prefer a master's degree or relevant certification.

• Experience:

  Prior experience in a clinical setting or in clinical research is highly valued, with many roles requiring one or more years of direct experience.

• Knowledge:

  Strong understanding of medical terminology, clinical research methodology, and regulatory guidelines (ICH-GCP, HIPAA, etc.).

• Soft Skills:

• Organizational and Time Management:

  Ability to manage multiple tasks, prioritize effectively, and meet deadlines.

• Communication:

  Excellent written and verbal communication skills for interacting with diverse stakeholders, including patients, physicians, and sponsors.

• Attention to Detail:

  Meticulous record-keeping and data collection are paramount to ensure the integrity of the study data.

• Problem-Solving:

  Proactive approach to identifying and resolving issues that may arise during a trial.

• Certifications (Preferred):

  Professional certifications, such as Certified Clinical Research Coordinator (CCRC) from the ACRP or Certified Clinical Research Professional (CCRP) from SoCRA, can enhance career prospects.