What are the responsibilities and job description for the Clinical Research Operations Manager position at SRA Trials?
Skills: Clinical Research Operations Manager
We seek a highly motivated and experienced Clinical Research Operations Manager to join our team. The successful candidate will oversee the day-to-day operations of clinical research studies, ensure compliance with regulatory requirements, and manage study timelines and budgets.
Responsibilities:
Responsibilities:
- Manage the planning, execution, and monitoring of clinical research studies
- Ensure compliance with regulatory requirements and ethical standards
- Collaborate with cross-functional teams to ensure successful study execution
- Manage study vendors and contractors
- Provide regular updates to senior management on study progress and issues
- Identify and mitigate study risks
- Ensure data quality and integrity
- Work closely with the Clinical Operations Director, Site Director, and Principal Investigators to coordinate all research activities on-site while ensuring protocol adherence and patient safety
- Serve and assist as the liaison between the Site and the Sponsor and FDA representatives
- Ability to multi-task and manage several projects in parallel, paying attention to detail
- Ensure that all clinical research duties are performed according to protocols, sponsor's guidelines, GCP & ICH guidelines, as well as local and FDA regulations
- Assist with Hiring and training all clinical department staff
- Team building and conflict resolution within the clinical team
- Assist the Clinical Operations Director in the process of seeking, vetting, managing, and training all vendors associated with the site
- Identify project issues such as resource, technical, or scheduling constraints, and assist in resolving issues internally and externally by performing risk assessments and developing summarized options and proposed solutions
- Ensure that projects are completed on time, within budget and scope, and conform to pre-established quality standards
- Primary contact to all the IRBs, CROs, Sponsors, and Study Vendors
- Assist during Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits
- Assist during Sponsor Audits and FDA Inspections
- Create GCP-compliant source documents and review all documents related to clinical trials
- Collect and distribute site metrics for internal departmental meetings and the site's Business Development department
- CTMS training and implementation
- Management of site calendar
- Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings
Requirements:
- Bachelor's degree in a scientific or healthcare-related field
- Minimum of 5 years of experience in clinical research operations management
- Strong knowledge of FDA regulations and ICH guidelines
- Excellent project management skills
- Strong communication and interpersonal skills
- Ability to work independently and as part of a team
- Strong problem-solving and decision-making skills
- Proficiency in Microsoft Office and clinical trial management systems
Job Type: Full-time
Benefits:
- Dental Insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8-hour shift
- Monday to Friday
- Weekend availability
Ability to commute/relocate:
- Miami, FL 33172: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person