Description
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions:
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Establish and agree on project planning and project timelines.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
Qualifications:
- Bachelor's Degree in life sciences or a related field and 3 years' clinical research or other relevant experience.
- 3 years clinical research experience, including 1 year experience in a leadership capacity.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Good negotiating and communication skills.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.