Clinical Study Coordinator

Join Kelly FSP as a Contract Clinical Study Coordinator supporting our Medical Device client.This position is a 6 month contract with the potential to extend. Hybrid Model: onsite Tuesday/Thursday and every other FridaySummary of the Job:The position is responsible for assigned Clinical Research tasks to support management of investigator-initiated and collaborative studies - Perform a variety of clinical research operations duties of a routine and technical nature in support of external research clinical trials. Other activities, special projects and assignments may be given as required.RESPONSIBILITIES:Assist external research director and manager with clinical research tasks.Specific responsibilities include: Assists the Clinical Director in daily management of external research activities - investigator-initiated studies (IIS) and collaborative studies including the following responsibilities:As directed, provides support to the project team which may include tracking study data, following-up with clinical sites on essential documents / information; assist in drafting of agenda/meeting minutes and scheduling of meetings.Performs data entry in systems for study management, payment set up and processingWorking collaboratively with legal/compliance and study institution/principal investigator on contract request, development, negotiation and executionWorking with internal stakeholders (scientific affairs – global and regional) in daily management of external research in other countries outside of United StatesFollows SOPs and using sound judgment to assure IIS programs are in compliance with legal, regulatory, and company process requirementsData entry for payment set up in internal systems, co-ordinates with external research partners to problem solve problemsDocuments & files as instructed – study updates - milestones, invoices and paymentsAssists with management of IIS submission portal and maintenance of IIS databaseManaging device orders, shipments, and returns with appropriate documentationAssist with file reviews and Audit preparationIs responsible for ensuring appropriate level of communication with managers, project leaders, and team members.Performs other duties assigned as neededREQUIREMENTS:Minimum of B.S.0-2 years experience in the pharmaceutical/biotech/medical device/CRO industry;Experience with clinical study management highly preferredKnowledge of good clinical practice and fundamentals of research highly preferredKnowledge of medical device/pharmaceutical industry processes preferredExcellent oral and written communication skillsAbility to work in a collaborative and multi-disciplinary environmentMust be detail oriented, highly organized, and able to work independentlyAbility to multi-task in a fast-paced environmentCompetency in tools of Microsoft office – excel, powerpoint, teamsProject management experience preferred