What are the responsibilities and job description for the Clinical Research Site Director - 238342 position at Medix?
Clinical Research Site Director
Must Haves : Must have experience running a team, hiring, firing, training, etc. Must have previous clinical research experience.
Hours : 40 hours per week, full-time, onsite, Monday-Friday 8am-5pm CST
Position Duration : Direct Hire - meaning you will be a permanent employee from day one.
Benefits : Medical, Dental, Vision, time off, monthly bonus plans, etc.
Role & Responsibilities :
Summary
The Site Director position is responsible for initiating, leading, and coordinating clinical research projects, reviewing clinical data, and ensuring compliance with protocols and overall clinical objectives.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ensure that procedures (including patient visits) are conducted according to IRB-approved protocols, sponsor instructions, established policies and procedures, applicable state and federal regulations, Good Clinical Practices (GCPs), and ICH / FDA guidance documents.
- Ensure that the site’s monthly visit goals are achieved by championing and holding staff accountable for goals and expectations.
- Direct the identification, screening, scheduling, randomization, and enrollment of patients in IRB-approved clinical trials, including research and pre-research activities.
- Perform or oversee direct patient care activities such as patient consent, physical assessments, blood draws, biological specimen handling, medication administration, FibroScans, ECGs, etc.
- Oversee Quality Control activities, day-to-day operations, and staffing for the assigned Research Center.
- Maintain effective and ongoing communication with sponsors, research staff, other team members, and investigators, including scheduling as applicable.
- Serve as the main point of contact to establish and maintain relationships with JV practices and vendors.
- Liaise between investigators, ancillary partners, physicians, research participants, sponsoring organizations, and regulating bodies while ensuring HIPAA regulations are followed.
- Ensure that study data is complete and accurate and entered into the sponsor’s EDC in a timely fashion.
- Supervise site initiation, study start-up, and close-out activities in coordination with Start-Up teams and Directors.
- Assist with the completion of site surveys / questionnaires received from Sponsors and CROs.
- Ensure all patient charts are reviewed by Clinical Research Coordinators before the first Site Monitoring Visit with the study sponsor.
- File and maintain documentation associated with clinical studies (including investigational product storage and accountability) per study protocols and sponsor requirements.
- Create and maintain up-to-date source documents for each study and ensure data accuracy and compliance with ALCOA-C principles.
- Investigate, track, and report Adverse / Serious Adverse Events and protocol deviations per sponsor requirements.
- Schedule and manage equipment calibrations as needed.
- Attend all site, company, and study-team meetings, participate in strategic planning, and attend investigator meetings or training sessions as required (may involve travel).
- Maintain a visit load of 10-12 visits per month (with Associate Director support) or coordinate up to 8 visits (without support).
- Participate in internal and external audits and ensure corrective / preventive actions are implemented.
- Effectively manage, coach, and lead Research Center staff, encouraging professional development and conducting performance reviews.
Required Competencies
Preferred Soft Skills
Supervisory Responsibility
The Site Director oversees Research Center staff and ensures clinical research projects comply with protocols and objectives. Responsibilities include training, mentoring, performance reviews, scheduling, and more.
Work Environment
This role operates in both clinical and office-based settings, with occasional lab work involving exposure to bodily fluids.
Physical Demands
This position involves sedentary desk work and active movement, such as standing, walking, and light lifting (up to 25 pounds).
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