Clinical Research Site Director
Posted on: May 23, 2023
Responsible for site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out.
Reviews proposed new research studies and determines projects to implement; negotiates budget and contract issues; initiates regulatory activities; oversees preparation of necessary project summaries, consent forms, etc. for IRB; oversees compliance with all regulatory requirements.
Directs financial oversight and management of clinical research unit; ensures invoicing is accurate and sponsor payments are received; ensures appropriateness of expenditures from various funding sources available to clinical research unit.
Identifies potential sponsors for clinical research unit; develops and oversees marketing strategies.
Designs, executes, and maintains an effective system of internal controls which provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable.
Participates in selection process of clinical research unit staff; provides training to research, financial, laboratory, and administrative staff; evaluates staff performance and implements measures necessary to maintain quality performance and results; participates in training, development and/or disciplinary measures; assesses policies and procedures to ensure optimal operation of clinical research unit.
Oversees on-going research studies and quality assurance measures, developing criteria where necessary; negotiates favorable agreements with laboratories and collaborators; monitors profitability of research studies; renegotiates contracts, etc. as needed.
- Schedules staff to cover subjects' visit needs.
- Works to ensure enrollment goals of the study center are being met.
- Supports the team and investigators in overall conduct of the trials.
- Follows the established monitoring SOPs both corporate and clinical, as well as protocol for specific monitoring plan.Create new SOPs as needed.
- Works with QA/QC program prior to sponsor visit.
- Oversees employees' work before monitoring.
Performs other duties as assigned.
- 5+ years of relevant experience as a clinical research site manager is required
- Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.
- Must have experience managing clinical research site.
- Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
- Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
- Strong written and verbal communication skills
- An ability to consume, absorb, and analyze large amounts of information.
- Ability to multitask, work under time constraints, work independently and cooperatively with interdisciplinary teams.
- Strong computer skills in appropriate software and related company clinical systems is required
Job Type: Full-time
Keywords: WayUp, Mesquite , Clinical Research Site Director, Healthcare , Mesquite, Texas
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