Clinical Trial Surgery Coordinator

Description

Job Title: Clinical Trial/Surgery Coordinator

Department: Clinical Trials and Surgery

Reports to: Director of Clinical Trials

FLSA Status: Non-Exempt

Pay Range: $24-26

Summary

The Clinical Trial/Surgery Coordinator fulfills a crucial role in performing and overseeing diverse tasks vital to the success of clinical trials and conducted at a research site. Serving as the primary liaison for research participants, coordinators uphold the safety and welfare of participants throughout the duration of the trial.

Essential Functions

• Surgical Scheduling and Coordination.
• Pre-Surgical Counseling.
• Prescriptions and Insurance.
• Documentation and Communication.
• Protocol Implementation.
• Participant Screening, Recruitment and Enrollment.
• Informed Consent and CA Bill of Rights Forms.
• Scheduling participant study visits fort screening, follow up, surgery and if needed, lab appointments.
• Data Collection and Management.
• Administering participant questionnaires for data collection.
• Participant Monitoring and Follow-up.
• Regulatory Compliance - Ensure trials adhere to regulatory, government, and ethical requirements.
• Communication and Collaboration.
• Maintaining research records.
• Help to record any adverse events or symptoms.
• As needed: Dispense trial medication, take and record vital signs and other protocol required testing.
• Attends investigator meetings as required or requested by the PI or Clinical Trial Director.
• Adherence to Ethical Standards.
  
  

Knowledge, Skills And Abilities

• Knowledge of clinical trial regulations and guidelines (e.g., ICH-GCP).
• Understanding of medical terminology and basic medical procedures.
• Familiarity with regulatory requirements and institutional policies.
• Knowledge of data collection methods and clinical research documentation.
• Understanding of ethical principles in human subject research.
• Excellent communication and interpersonal skills.
• Strong organizational and time management skills.
• Attention to detail and accuracy in data collection and documentation.
• Ability to work effectively in a team environment.
• Problem-solving and critical thinking skills.
• Proficiency in computer applications (e.g., Microsoft Office, electronic data capture systems).
• Ability to multitask and prioritize tasks effectively.
• Must be very organized.
• Capacity to work independently with minimal supervision.
• Flexibility to adapt to changing priorities and responsibilities.
• Ability to handle confidential information with discretion.
• Aptitude for learning new technologies and procedures.
• Capacity to remain calm under pressure and in challenging situations.
  
  

Requirements

Minimum Qualifications:

• A bachelor’s degree in a related field such as life sciences, nursing, or healthcare administration is preferred or 2 years’ experience in related field.
• Prior experience working in clinical research or a related field preferred.
• Current certification in Human Subject Protection (HSP) and Good Clinical Practice (GCP) is mandatory. If not already certified, these certifications shall be obtained within 5 business days of employment.
• Proficiency in relevant software applications and electronic data capture systems.
• Strong written and verbal communication skills.
• Detail Oriented.
• Ability to effectively manage high stress situations.
  
  

Environment

Physical Requirements/Typical Working Conditions

• Primarily a temperature-controlled facility.??
• Work may require prolonged sitting, some bending, stooping, and stretching.???
• Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, mouse, and standard office equipment.???
• Requires normal range of hearing and eyesight to communicate in person, by phone, or over video.???
• Requires occasional lifting papers or boxes up to 30 pounds.?
  
  

Essential Physical Tasks

Sight – sufficient to read physical documents, and images on a computer monitor.??

Smell – sufficient to discern smoke/something burning, and other odors.?

Hear – sufficient to hold face to face/telephone/video call conversations, and to discern other ambient noises.??

Touch – sufficient to operate keyboard, mouse, other standard office equipment, and writing implements.?

Physical ability/strength – sufficient to lift, twist, turn, reach, climb, kneel, squat, sit, walk, stand, bend as needed throughout a standard shift.?