Description
We are looking for a Contract Specialist to join our Country Site Activation team!
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.
Responsibilities:
- Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Contract negotiations with research sites.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- 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.
Requirements:
- +2 years clinical research experience in contract negotiations with clinical research sites
- Health Sciences degree
- Advanced command of English language.
- Desirable experience in regulatory submissions & imports/exports that correspond to activities subsequent to the authorization of a clinical protocol in the country.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Excellent organization and prioritization skills
- Excellent communication and interpersonal skills