לוח משרות דרושים רפואה ופארמה

As a CTC, you will provide administrative and technical support to the Project Team. Support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provide administrative support for site activation activities. Aid the development of the critical path for site activation within assigned projects in support of rapid site activations.

A day in the Life:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Where applicable, conducts on-site feasibility visits (APAC only).
May support scheduling of client and/or internal meetings.
May review and track of local regulatory documents.
May provide system support (i.e., Activate & eTMF).
May support RBM activities.

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Duties and Responsibilities:
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters using approved business writing standards. Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.