Site Manager in Houston, Texas at American Clinical Research Services Opco LLC

Overview: At Empathx, we drive equitable access to complex trials at any phase by providing industry-leading patient access, clinical trial management, and analysis across, psychiatry/neurology, metabolic, and infectious disease studies throughout the therapeutic pipeline.

Position Summary: The Site Manager oversees daily operations at the Empathx Houston site, managing a portfolio of Psychiatry, Central Nervous System (CNS), and psychedelic studies across Phase I–IV. This role supervises site staff, serves as the primary point of contact for sponsors and CROs, and performs clinical procedures as needed. The Site Manager ensures studies meet enrollment targets and are conducted in compliance with protocol, ICH-GCP, and FDA requirements.

Duties and Responsibilities:

Site Operations & Study Management

• Oversee day-to-day operations of the Houston site, managing a portfolio of three (3) or more concurrent studies across Phase I–IV
• Manage study start-up activities, including feasibility questionnaires, site qualification visits, and site initiation visits
• Coordinate study visit schedules and ensure protocol-required procedures are completed accurately and within visit windows
• Monitor enrollment and retention against sponsor targets and partner with recruitment to meet study timelines
• Maintain study, participant, and visit data in RealTime CTMS
• Serve as the primary site contact for sponsors, CROs, and monitors; host monitoring visits and resolve action items and data queries in a timely manner
• Coordinate with the Dallas site to align processes and share resources as needed

Clinical Procedures

• Perform blood draws, EKGs, and vital signs per protocol
• Complete participant visits and ensure timely and accurate data entry in the CTMS/EDC systems
• Process, package, and ship laboratory specimens per protocol and shipping requirements
• Coordinate dosing-day and extended visit logistics for psychedelic studies, including participant monitoring and safety procedures per protocol

Regulatory, Quality & Compliance

• Ensure all studies are conducted in compliance with ICH-GCP, FDA regulations, IRB requirements, study protocols, and company SOPs
• Oversee the informed consent process and ensure consent is obtained and documented appropriately
• Ensure accurate, timely source documentation and EDC data entry
• Oversee reporting of adverse events, serious adverse events, and protocol deviations within required timelines
• Maintain regulatory documents and study files in an inspection-ready state
• Oversee investigational product receipt, storage, accountability, and return/destruction, including controlled substance handling and recordkeeping requirements

Leadership & Mentorship

• Supervise site staff, including assigning work, setting priorities, and monitoring performance
• Review and approve employee timecards and time-off requests
• Conduct performance reviews and implement performance improvement plans (PIPs) as needed
• Participate in recruiting, interviewing, and hiring decisions for site staff
• Oversee onboarding and training of new staff on protocols, SOPs, and clinical procedures
• Partner with HR on corrective action and terminations
• Support audit and inspection readiness, including participation in sponsor audits, regulatory inspections, and internal quality reviews
• Complete all required SOP training and company-required trainings as assigned and when updated
• Maintain all required licenses and certifications and ensure they remain current and in good standing
• Travel to company meetings, site locations, or study-related activities as required
• Perform other duties as assigned

Qualifications:

• Bachelor's Degree (BA) from four-year college or university, or one to two years of related experience and/or training, or equivalent combination of education and experience.[KD9]
• Perform blood draws, EKGs, and vital signs per protocol
• Process, package, and ship laboratory specimens per protocol and shipping requirements
• Coordinate dosing-day and extended visit logistics for psychedelic studies, including participant monitoring and safety procedures per protocol
• Complete participant visits and ensure timely and accurate data entry in the CTMS/EDC systems
• Experience with Phase I, II, III, and IV clinical trials

Certificates, licenses and registrations required:

• ACRP or SOCRA certification (preferred)

Systems & Technology skills required:

• Spreadsheet Software (Excel);
• Word Processing Software (Word);
• Electronic Mail Software (Outlook);
• Presentation software (PowerPoint);
• Experience with EDC systems (e.g., Medidata Rave, REDCap)
• Experience with CTMS and/or eRegulatory/eTMF platforms (e.g., Veeva)
• Experience with EMR/EHR systems

Other skills required:

• Fluency in Spanish is preferred.
• Proficiency in blood draws, EKGs, and vital signs
• Familiarity with psychiatric rating scales (C-SSRS, MADRS, CGI, SCID, HAM-D) preferred
• Strong working knowledge of ICH-GCP and FDA regulations
• Demonstrated ability to supervise and develop staff
• Ability to travel occasionally to the Dallas, TX site as needed
• Strong attention to detail and accuracy
• Ability to manage multiple tasks and priorities
• Strong organizational and time management skills
• Ability to work independently and as part of a team
• Effective communication and interpersonal skills
• Ability to maintain confidentiality and professionalism
• Strong problem-solving and critical thinking skills
• Ability to adapt to changing priorities
• Ability to exercise sound judgment and decision-making
• Customer service mindset with focus on patient experience
• Ability to follow protocols, SOPs, and regulatory requirements
• Ability to handle high-pressure or fast-paced environments

Physical Requirements and/or environmental factors:

• Continually required to stand.
• Continually required to walk.
• Continually required to sit.
• Continually required to utilize hand and finger dexterity.
• Frequently required to climb, balance, bend, stoop, kneel or crawl.
• Continually required to talk or hear.
• Occasionally required to taste or smell.
• Occasionally works around fumes, airborne particles, or toxic chemicals.
• Occasionally exposed to outside weather conditions.
• Frequently exposed to bloodborne and airborne pathogens or infectious materials.
• While performing the duties of this job, the noise level in the work environment is usually moderate
• The employee must
  • Occasionally lift and/or move up to 20 pounds
• Specific vision abilities required by this job include:
  • Close vision
  • Distance vision
  • Color vision
  • Peripheral vision
  • Depth perception
  • Ability to adjust focus
• Specialized equipment, machines, or vehicles used:
  • Phlebotomy supplies, EKG machine, vital signs equipment, and centrifuge
• This position operates in a clinical research and office setting. The role involves interaction with study participants, healthcare professionals, and research staff. Work may include use of electronic systems and medical equipment, as well as occasional travel to clinical sites or meetings.

Equal Opportunity: Empathx is committed to fostering a diverse, inclusive, and equitable workplace where all employees and applicants are treated with respect and dignity. We are proud to be an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, marital status, national origin, ancestry, age, disability, genetic information, veteran status, or any other protected characteristic under applicable law.