Christopher Weeks Email & Phone Number

Boston, Ma

Achievements• Study Lead on early feasibility study for drug-eluting balloon: 3 sites, 15 subjects• Site Manager on clinical trial comparing drug-eluting stents: 150 sites, 1,334 subjects• Co-Lead on clinical trial comparing drug-eluting balloons: 50 sites, 446 subjectsResponsibilities• Responsible for overall conduct and site management of multiple clinical trials and ensure studies are compliant with GCP and regulatory guidelines• Manage in-house and field CRA study team and insure compliance to the protocol and monitoring plan• Coordination and review of monitoring visits• Develop and track time lines for studies, track enrollment progress, and ensure completion occurs on target• Performance reviews and resourcing evaluations for clinical study team• Cross-functional team that reviews and provides feedback for new protocols• Primary clinical liaison with sponsor • Lead and participate in team meetings• Train and coach internal employees and study site staff • Draft monitoring plan and action plans for assigned studies• Develop informed consent, regulatory binder templates and other resource materials• Manage all aspects of investigative sites from start-up to close out• Establish and maintain primary communication with clinical sites and field CRAs• Negotiate site informed consent forms• Oversee investigator site payments• Identification and evaluation of investigators and sites during site selection process• Participate in completion of protocol, case report forms, clinical site agreements, and budgets

Billerica, Ma

-Develop protocol, case report forms, and regulatory documents for clinical studies-Manage clinical and human factor studies-Create risk analysis worksheets-Write clinical evaluation reports to support regulatory submissions-Oversee consultants-Collaborate with product development team as clinical representative

Danvers, Ma

-Train and provide management of clinical research specialist-Oversee and track third-party vendors and core labs-Perform site qualification visits and study presentations-Represent company during site trainings-Evaluate and provide site selection recommendations to Sr. Management-Develop study templates and communications

Danvers, Ma

-Train and provide management of project coordinators-Assisted in oversight of third-party vendors and core labs-Represented clinical in vendor audits-Composed 6 month investigator report, and assisted with annual and final reports for the FDA

Danvers, Ma

-Managed all aspects of site activation, including preparation of start-up documentation, distribution, receipt, review, authorization, and close out-Audited site documentation and maintained study files according to FDA regulations-Negotiated and approved informed consents, contracts, and budgets-Oversaw device distribution and reconciliation-Coordinated field staff activities with clinical staff needs-Oversaw follow-up and resolution of site issues noted by field staff-Developed and maintained multiple study reports used to track milestones and ensure study site compliance

Master Of Business Administration (Mba)

Bachelor Of Science (Bs), Registered Nursing/Registered Nurse

Bachelor Of Science (Bs), Psychology