Clinical Research Site Operations Manager

Job Title: Site Operations Manager

FSLA Classification:  Exempt

Reports to: VP of Operations

Job Summary/ Objective:

The Site Operations Manager in Clinical Research oversees the operational aspects of clinical trial sites. This pivotal role involves ensuring compliance with protocols, managing site resources, coordinating with stakeholders, and optimizing processes to facilitate efficient and ethical conduct of clinical research studies. 

Essential Functions:

• Clinical Site Management
  • Supervise day-to-day operations at clinical trial sites, ensuring adherence to protocols, guidelines, and regulations.
  • Coordinate site activities, including participant recruitment, data collection, and study procedures, to meet project timelines.
• Compliance and Quality Assurance
  • Ensure strict adherence to regulatory standards, ethical practices, and study protocols.
  • Conduct regular site audits to maintain compliance with applicable regulations and quality standards.
• Stakeholder Coordination:
  • Collaborate with principal investigators, sponsors, and ethics committees to facilitate communication and resolve site-related issues promptly.
  • Act as the primary point of contact between the site and sponsors, providing updates on study progress and addressing queries.
• Resource Management:
  • Manage site resources effectively, including staff, equipment, and supplies, to support smooth trial operations.
  • Optimize resource allocation to ensure efficient utilization and cost-effectiveness.
• Training and Development:
  • Provide training to site staff on study protocols, procedures, and regulatory requirements.
  • Foster a culture of continuous learning and skill development among site personnel.
• Data Management:
  • Oversee accurate and timely data collection, ensuring data integrity and quality control measures are in place.
  • Collaborate with data management teams to resolve data discrepancies and maintain data accuracy.
• Budget Management:
  • Assist in budget planning and monitor site-related expenses, ensuring cost-effective utilization of funds.
  • Work closely with finance departments to manage site budgets and financial reporting.

Education/Experience/Skills:

Education: Bachelor's degree in relevant field (master’s preferred)

Experience: Minimum of 5 years’ experience in clinical research site management

Skills: (please refer to the Helios Upskilling Guide for the complete list of all skills required for this role)

• Regulatory
  • Filing and accessing documents, Study Submission Assistant, Conduct Close out Visits
• Finance
  • Stipend payments
  • Manage site budget
• Subject Interaction
  • Recruit, interview, screen, enroll, and randomize subjects
  • Obtain Informed Consent
  • Collect medical history
  • Conduct study visits
• Administrative
  • Source documentation
  • EDC
  • Query resolution
  • AE/SAE documentation and reporting
  • Address protocol violations and deviations
  • Order supplies
• Clinical Skills
  • Phlebotomy
  • Vital Signs
  • ECG
• Study Management
  • Conduct PSSV’s and SIV’s
  • Complete Feasibility Questionnaires
  • Manage trials from start to closeout
• Staff/ Site Management
  • Direct and supervise daily work activities
  • Educate on local, federal, state, and institutional policies
  • Oversight of protocols
  • Manage trials from start to closeout
  • Conduct staff performance evaluations
  • Assess/ Communicate staffing need

Working Conditions/ Physical Demands:
Standard operating hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. May be required to complete job-related tasks outside of that time frame in excess of a standard 40-hour work week.  Requires prolonged walking, standing, some bending, stooping, and stretching.  Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.  Requires normal range of hearing and eyesight to record, prepare, and communicate appropriate reports.

Travel required: 30%