Clinical Research Positions

Project Manager

Provide leadership in the development of study-related documents, including study protocols, informed consent documents, investigator files, DSMB handouts and presentations, CEC summaries, etc.;Establish close working relationships with physicians, their research staff, outside onsultants and the study sponsor through exceptional communication on a regular basis;Provide review and approval of invoices from study vendors, IRB approvals and informed consent documents, onitoring reports, clinical study agreements, etc.;Provide leadership in regularly scheduled study team meetings with both internal and external resources;Act as a liaison between the study sponsor, the CRO and investigative sites;Coordinate the efforts of the project team, including Clinical Research Associates, Clinical Specialist, Global Site Development, Contracts Management, etc.;Work closely with the Director of Clinical Trials to develop and implement specific study plans and ensure that appropriate resources are available for the project;Participate in and conduct visits and meetings with investigative sites, physicians and consultants, as needed;Responsible for achieving study objectives by working with team members to set project priorities and milestones and resolve project conflicts;Respond promptly and appropriately to study issues raised by investigative sites, sponsors, monitors and consultants; andParticipate in the analysis, summary and reporting of clinical data for regulatory or marketing purposes through the course of the study.

Minimum of Masters in Health, Life Sciences or Biomedical Engineering required;Previous experience in the conduct of clinical studies, preferably in the medical device industry;Working knowledge of FDA and other regulatory requirements that may impact global clinical studies;Conscientious, influential person with an outstanding work ethic and strong personal discipline;Willingness and capability to handle multiple projects and responsibilities;Excellent organizational, leadership and problem-solving skills; and Excellent written and verbal communication skills. Global presentation capability.

Clinical Research Associate
Performs background research, writes protocols and designs case report forms for studies of mid-level complexity for all classes of ophthalmic surgical devices. Assists in the recruitment of investigational sites and conducts prestudy education toward the goal of assuring that desired research data is collected.Obtains necessary study approvals. Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary Responsible for building own expertise through attendance at courses, seminars and meetings.Reads professional journals and publications to stay abreast of regulatory and scientific developments Accountable for the successful execution of assigned studies.Scope includes communication with investigational sites regarding study conduct, assisting with study design and development of all study documents including contracts, protocols and reports. Reports to Clinical Research Manager.

Skills:he candidate must have the ideal skill set, strong (outgoing/bright) personality, self starter, multi tasker. The candidate must have a minimum of 2 yrs monitoring experience. Must be proficient with excel and word. Must have prior experience in MEDICAL DEVICE, not pharma.
We prefer (not a must have) a candidate with prior experience in ophthalmology. the position will require about 30-35% travel. Manages data retrieval and performs medical audit of incoming data.
Investigates potential adverse events. Maintains constant communication with research sites and performs regular on-site audits to assure adherence to study protocol and effective enrollment.
Assists in the preparation of interim reports of progress. Concludes study at predetermined point or earlier in presence of certain indications. Develops preliminary interpretation of study results and drafts final reports and presentations.



Financial Management Positions

1. Budget Analyst
2. Financial Manager for Investors and marketing

General Accounting Position

Accounting Consultant, New York, NY Prep, exam, analyze accounting records; prep & analyze financial statements; maintain financial books & records; revolving balance sheets & cash flow statements; prep analyses of fin position; compute taxes; assess current & projected fin position; analyze prospective bus transactions; project revenue, expenses, profits; compute net margins for bus oppourtunities; recommend viability of transactions in view of finance & accounting info; arrange loans & equity invstmts; negot transactions & mergers. BS Acctg or rel fld + 2 yrs exp in job offrd.