Site Manager

American Clinical Research Services Opco LLC•Houston, TX

39d•$85,000 - $110,000•Onsite

About The Position

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. 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.

Requirements

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.
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
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
Proficiency in blood draws, EKGs, and vital signs
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

Nice To Haves

ACRP or SOCRA certification
Fluency in Spanish
Familiarity with psychiatric rating scales (C-SSRS, MADRS, CGI, SCID, HAM-D)

Responsibilities

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
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
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
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