Clinical Research Site Manager
Atlanta, Georgia, United States
WR- Mount Vernon Clinical Research , LLC , site location for M3 Wake Research Inc. an integrated research site network, is seeking a Clinical Research Site Manager to oversee all aspects of the clinical trial management for their Sandy Springs, Georgia location and act as a point of contact in site management practices.
- Site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out
- Conducting pre-study site selection visits and assessments
- Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
- Scheduling of staff to cover subjects visit needs
- Conducting staff reviews
- Work to assure enrollment goals of the study center are being met
- Monitor subject visits
- Support the team and investigators in overall conduct of the trials
- Follow the established monitoring SOP’s both corporate and clinical as well as protocol for specific monitoring plans.
- Work with QA/QC program prior to sponsor visit.
- Oversee employees work before monitoring.
- Review budgets that clinical research costs and physician’s costs are covered.
- Work with the corporate office for evaluating recruitment plans and study start up.
- Oversee training for all protocol training as well as required for regulations, compliance and up-to-date training.
- A minimum of five (5) years relevant experience as a clinical research associate or clinical research coordinator is a must.
- Site management background is required for this position. Only qualified and experienced applicants will be considered.
Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.
- Must have experience managing trials.
- Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
- Solid teamwork, organizational, interpersonal, and problem-solving skills.
- Strong communication and written skills, attentive to detail and proficient computer skills.
- An ability to consume, absorb, and analyze large amounts of information.
- Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams.
Strong computer skills in appropriate software and related company clinical systems is required
- Competitive salary
- Comprehensive benefits package – Medical, Dental, Vision, Life , FSA and 401K
- Paid time off