Site Supervisor

Job Overview:

The Site Supervisor plays a crucial role in overseeing the day-to-day operations of clinical trial sites. The primary responsibility of this role is to ensure that all trial activities at the site are conducted in compliance with the study protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The Site Supervisor will lead the site team, manage patient recruitment and retention, ensure proper documentation and data collection, and maintain effective communication between the site and the sponsor or clinical research organization (CRO).

Key Responsibilities:

• Site Management:
• Supervise the clinical trial site operations to ensure compliance with the study protocol, timelines, and regulatory requirements.
• Manage site staff (e.g., research coordinators, raters, and other site personnel) and ensure they are trained, motivated, and following all protocol guidelines.
• Oversee patient recruitment, enrollment, and retention efforts, ensuring targets are met while maintaining high ethical and regulatory standards.
• Protocol Adherence and Compliance:
• Ensure that all clinical trial activities are conducted in accordance with the study protocol, GCP, ICH guidelines, and other applicable regulations.
• Review and approve informed consent documents, ensuring participants fully understand the nature of the study and their involvement.
• Monitor and ensure the correct use of investigational products (medications, devices, etc.) and ensure proper documentation of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
• Data and Documentation Oversight:
• Ensure the accuracy, integrity, and completeness of clinical trial data, including case report forms (CRFs), source documents, and participant records.
• Coordinate with the data management team to ensure timely and accurate submission of study data.
• Ensure that study documentation (e.g., regulatory binders, informed consent, source documents) is complete and up to date.
• Team Leadership and Training:
• Supervise site staff, including research coordinators, research nurses, and raters, providing guidance, training, and support as needed.
• Organize and lead site team meetings to ensure smooth trial execution and address any issues that arise.
• Identify training needs for site staff and arrange for training or refresher sessions, as required by the study.
• Communication and Reporting:
• Serve as the primary point of contact for the sponsor, clinical research organization (CRO), and any other stakeholders involved in the trial.
• Provide regular updates on site progress, participant enrollment, and any issues encountered to the clinical research manager or principal investigator.
• Address and resolve any concerns from participants or site staff in a timely and professional manner.
• Quality Control and Audits:
• Perform routine quality control checks to ensure compliance with the protocol and regulatory requirements.
• Participate in internal or external audits, inspections, or regulatory visits, ensuring the site is fully prepared for inspections and meets compliance standards.
• Patient Safety and Support:
• Ensure participant safety by closely monitoring clinical trial procedures and supporting participants throughout the study.
• Address any concerns related to patient care and safety, and report any adverse events or protocol deviations in a timely manner.

Qualifications:

• Education:
• Bachelor's degree in Life Sciences, Nursing, Healthcare, or a related field. A Master’s degree or equivalent experience may be preferred for senior roles.
• Experience:
• At least 3-5 years of experience in clinical research or clinical trials, with a solid understanding of clinical trial operations.
• Previous experience as a Clinical Research Coordinator (CRC) or in a similar role, with expertise in managing clinical trial sites and teams.
• Skills:
• Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and other regulatory requirements.
• Excellent organizational skills with the ability to prioritize tasks, manage multiple aspects of the trial simultaneously, and ensure timelines are met.
• Ability to supervise and lead a diverse team, providing clear direction and fostering effective teamwork.
• Strong interpersonal and communication skills to interact with participants, site staff, sponsors, and regulatory bodies.
• Familiarity with clinical trial management software (CTMS), electronic data capture (EDC) systems, and other clinical trial documentation systems.

Preferred Qualifications:

• Certification:
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) through organizations like the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) is a plus.
• Experience:
• Previous experience in managing or overseeing clinical trial sites in therapeutic areas such as oncology, neurology, psychiatry, or cardiology.
• Technical Skills:
• Proficiency with electronic medical records (EMR) and data management systems used in clinical trials.

Working Conditions:

• Location: On-site at the clinical trial location (255 S Dobson Rd, Suite 4, Chandler, AZ 85224).
• Hours: Full-time, with flexibility required to meet study deadlines and participant schedules. Occasional evening or weekend work may be required.
• Travel: Travel may be required for multi-site studies or training sessions.

Job Types: Full-time, Contract

Pay: $75,000.00 - $95,000.00 per year

Benefits:

• Flexible schedule
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Commute:

• Scottsdale, AZ 85260 (Required)

Ability to Relocate:

• Scottsdale, AZ 85260: Relocate before starting work (Required)

Work Location: In person

Salary : $75,000 - $95,000