Responsible for supporting the sponsors’ Project Management Team in the oversight of 30 – 40 clinical sites for assigned protocols. This oversight may include: assisting the project team with tracking various site metrics and deliverables; consulting in the development of patient recruitment strategies and materials; assisting sponsor project team with or management of regulatory and IRB/EC submissions; may manage query resolution process with sites and sponsor-assigned Data Management personnel; and attendance at and participation in sponsor internal and external meetings; Additional duties may include site monitoring based on sponsor project expectations and/or status (i.e., query resolution/database clean time, non-compliant sites, high-enrolling sites, etc.).
PRIMARY JOB FUNCTIONS:
First line of contact to address non-medical site questions as outlined in the local Trial Operations Plan created by the project team.
Track protocol violations by creating and maintaining a PV log from site visit reports.
Provide protocol amendments to site as needed and track receipt/signature pages
Track submission of protocol amendments and revised ICFs, IRB approvals, 1572 changes (including obtaining medical licenses and CVs related to these changes) correspondence, site changes.
Review and approve advertising with project team.
Works with sponsor regulatory document review team to track release of sites and verifies when sites are ready for drug shipments.
Initiate the IVRS/ IWRS system after regulatory approval has been obtained and the site budget/contract has been executed.
Ensure ample drug supply is available to meet projected enrollment at each site including IVRS.
Complete drug shipment orders for non-IVRS trials.
Follow up with assigned sites to confirm that sites have adequate supplies and equipment as required by protocol.
Identify issues in the site visit reports and create and manage a list of outstanding issues, follow up on site issues to resolution within an agreed upon timeline.
Confirm that all key site personnel have completed Investigator meeting training and any study specific training modules as identified in the training plan.
Provide and track training documentation such as attendance certificates if applicable.
Develop or contribute to newsletters for assigned studies based on information provided by CML and/or CRA Manager.
Maintain FAQ list for assigned trial(s)
Follow-up on site patient recruitment with site coordinators and CRAs.
Provide feedback to project team if recruitment falls below expectations.
Follow-up with sites on data entry and cleaning to ensure that trial is being performed according to protocol and agreed upon timelines.
Review various trial listings and follow-up with sites as required.
Submit regulatory documentation and correspondence to the designated personnel for filing in the Clinical Trial Master File (CTMF). Perform CTMF reconciliation for assigned studies on a quarterly basis or as directed by the CML.
Review and reconcile site invoices.
Attend regularly scheduled trial team meetings.
Maintain and update all internal and external trial spreadsheets.
Maintains overall awareness in the field of Clinical Research, as well as assigned therapeutic areas, by reading related literature, attending training classes, attending professional meetings, etc.
To update CV and Training records as necessary and make available for sponsor review where appropriate
Remains alert for new business opportunities, network, and provides information to business development staff or manager
May participate in the development, training and updating of clinical Standard Operating Procedures, Local Working Guidelines and departmental policies
Performs other work-related duties as assigned
Requires a degree in the life sciences, or equivalent experience and a minimum of 5 years relevant experience in clinical research, preferably with a minimum of 3 year as a Sr. CRA and/or project lead
Knowledge and experience with FDA/ICH or ISO 14155 regulations, drug development. GCP and clinical monitoring procedures are necessary
Requires effective presentation, documentation, interpersonal, decision making and leadership skills, as well as strong team-oriented approach
Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential
Strong computer skills are necessary
A willingness to travel and fluency, both written and oral, in the English language are required