Sr Clinical Research Spec

SUMMARY:  The principle focus is in the support of physician directed clinical research prioritized within the respective sub-specialty Study Groups, such as Spinal Deformity, Spine Trauma, Spine Oncology and Degenerative Spine. The Sr. Clinical Research Specialist supports the development and implementation of major study group meetings, clinical studies, clinical advancement projects, evidence development, peer review publications/presentations and educational programs. The Sr. Clinical Research Specialist will manage information flow from business partners in order to optimize support for the efforts of study site Research Coordinators. The Sr. Clinical Research Specialist is responsible for the maintenance and tracking of research support agreements. The Sr. Clinical Research Specialist reports to the Sr. Manager, Clinical Advancement, Research and Development.

Position Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Manages Study Group activities:
? Works closely with key global surgeon leaders, external business partners, research institutions  and Clinical Advancement, Research and Development staff in the development of Study Group meeting agendas, logistics, study protocols, CRF’s, IRB submissions, patient enrollment, follow-up and data collection.
? Works with strategic business partners, key surgeon leaders, and academic institutions in the development and implementation of advanced logistics and systems for the acquisition, transfer, management and analysis of clinical data and digital radiographic images.
? Coordinates and supervises internal and external resources in the conduct of clinical studies to assure that study files, reports, and clinical data are received, evaluated and entered into database management systems.
? Maintains a high level of professional expertise through familiarity with clinical literature, contemporary medical education and advancements in clinical care.

Oversees research agreement management:
? Serves as liaison to Legal Department in developing and renewing research agreements (including completing and submitting requests for non-disclosure and research agreements)
? Works with internal resources, subcontractors and strategic business partners to develop and manage the departmental research agreements database.
? Performs data entry and is responsible for accuracy of departmental research agreement database. Provides basic review of all research agreements for tracking and database set-up
? Tracks and processes site-specific enrollment and follow-up reports from strategic business partners. Calculates and tracks research agreement payments; serves as liaison to Accounts Payable Department in processing research agreement payments

Liaises with business partners, study group physician members and study site research coordinators:
? Works with strategic business partners, in consultation with study site lead coordinators, to create/revise study management reports to optimize their value
? Acts as first contact for study site lead coordinators on study management issues; communicates with clinical sites and conducts periodic site visits where indicated
? Monitors study enrollment and assists study site lead coordinators in devising strategies to maintain high levels of enrollment and follow-up
? Schedules and facilitates teleconferences as required to discuss data collection and data quality issues, disseminate study related updates, and coordinate study management planning.
? Provides guidance to Study Lead Coordinators on study conduct
? Organizes and facilitates Study Group physician member teleconferences as requested.
? Facilitates and supports study group physician members and leaders in driving clinical research publication strategies

Basic Qualifications

QUALIFICATION REQUIREMENTS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:  Bachelor’s degree, preferably in a life science or scientific related field and minimum of five years clinical research experience in a fast-paced medical or office environment, or RN or BSN degree and five to eight years experience in clinical trials and site coordination (industry/institutional setting preferred). Master of Science in life science or related field preferred. Experience with clinical outcomes research, clinical trials, clinical data collection and management, good clinical practices, and research protocol preparation is required.

OTHER SKILLS and ABILITIES:
Solid Work Ethic
Ability to maintain confidentiality in regard to contracts and personnel issues.
Superior communications skills, including interpersonal, presentation, and written
Ability to work independently in a fast-paced, customer driven matrix style environment
Excellent computer proficiency; basic office machine skills.
Software proficiency in all MS Office programs, i.e., Word, PowerPoint, and Excel.
A high degree of organizational skills and attention to detail.
Demonstrate the ability to manage multiple tasks, define workflow priority, take ownership and work flow initiative.
Analytical skills highly desired.
Exhibit stellar customer service skills.
Effective time management, project management and organizational skills.
Overnight travel required (

Desired/Preferred Qualifications

Master of Science in life science or related field preferred.

Physical Job Requirements

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls.  The employee is occasionally required to reach with hands and arms.  The employee must occasionally lift and/or move up to 15 pounds.  Specific vision abilities required by this job involve normal vision.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet to moderate.