• Responsible for coordinating the regulatory clinical trial applications (CTA) submission activities for assigned clinical trials.• Represents Regulatory Affairs in the SMTs (provide regulatory strategy & overseeing activities conducted by the CRO).• Responsible for the global CTA submission strategy & managing CRO.• Facilitates the gathering of/or author documents to be included in the CTA.• Primary contact between Regulatory and the CRO for the management of submissions of CTAs.• Ensures Submissions and approval events are tracked in a timely manner.

Supported the ICF Manager with oversight of various aspects to the Partnership. The central contact for the Informed Consent (IC) department. Helped identify and support resolution of ICF issues.Developed and maintained the Informed Consent ShareNet site, Excel Spreadsheets; ensured content was correct and access levels were appropriate.Ensured timely and accurate ICF-related communication to personnel (i.e., internal, external and consultants)

•In addition to working on multiple clinical trials (Phase I-IV); provided day-to-day mentorship and guidance to CTCs & Senior CTCs. •Facilitated monthly CTC Group Trainings/Refreshers to ensure training and knowledge levels of core CTC/CTA tasks. •Provided application software training (CTMS) to new CTCs/CTAs to ensure all trial data was captured for upper management reporting.

•Ensured timely and accurate study-related communication to clinical personnel (i.e. internal and external study teams, consultants, investigators, and site personnel).•Collected and disseminated trial information to the internal project team, CROs, site personnel, and consultants.•Assisted with the creation of study specific manuals, tools and templates.•Coordinated specified clinical trial meetings (i.e. Investigator Meetings, Kick-Off Meetings, CRA Meetings, CRO Meetings, and Internal Study Management Team Meetings).•Set-up, tracked, and archived audit-ready clinical trial (Regulatory/IRB/EC ) documentation.•Assisted with the set-up of clinical trial supplies through external vendors (CRFs, Study Manuals, Lab kits, etc.).

Same tasks as the Sr. Clinical Trial Coordinator title.

•Handled high level patient referrals from physicians.•Case managed patients and assisted them with getting started on Avonex:Answered questions regarding MS and Avonex;Delivered Insurance benefits and/or obtained Prior Authorization as needed for drug coverage;Coordinated patient training with an Interim Nurse to learn how to do injection of drug.

•Answered high volume inbound calls regarding Multiple Sclerosis and Avonex related questions.•Directed calls regarding refills and billing.•Provided relevant educational materials as needed.

•Potential Patient Spokesperson for Lymphedema Treatment.•Followed up w/ patients registration, medical history, and treatment schedules.•Verified and obtained pre-certification/authorization numbers and referrals for additional visits.•Performed Check-in, verfication of demographic information and collected co-pays.