Job Description

Description: Clinical Research Associate II Tracking Code 303981-578 Job Description To implement and ensure that clinical research compliance is maintained both domestically and internationally for clinical trials performed by or for Orthofix, Spinal Implants. Completes project activities associated with monitoring functions of clinical research studies while developing an understanding of the medical device development process, Good Clinical Practices, and relevant regulations. Provide clinical and technical support for junior CRAs and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).

May assume the role of a Lead CRA on projects by providing direction and guidance to the project team, coordinating all monitoring activities and communicating the status of these activities to management.
Required Skills
DUTIES AND RESPONSIBILITIES (essential functions of position):
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Work with leading clinicians and surgeons to develop study protocols.
Assists with the development of study specific informed consent forms, monitoring plans, CRFs, monitoring conventions, tracking forms, and other study related documents.
Assist in the preparation of Investigational Plan section of IDE, including; protocol, statistical data analysis plan, monitoring plan, informed consent form, case report form, investigator agreement and financial agreement, as required.
Assists in site selection, and pre-study activities to identify and evaluate potential investigators. Completes site evaluation for qualification/selection of potential investigators/sites and reports to management as appropriate.
Assure positive relationship with investigational sites and when required act as primary contact with leading clinicians and surgeons for specific project related activities.
Performs clinical trial initiation, monitoring and close-out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs), including:
Assist with IRB submissions ie completes submission of documents to the IRBs when required
Training site personnel ie protocol requirements, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, reviewing SAE reporting requirements, and reviewing device storage and accountability procedures.
Complete pre-study visits with study site staff ie completes study start-up activities
Complete initiation visits with study staff
Timely payment of grants ie manage and track investigator grants with study sites when required
Complete monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting in accordance with project plan.
Assure adequate supplies.
Completes study site close-out visits.
Collects, reviews and tracks regulatory documents when required.
Anticipates/identifies potential problems and implements corrective actions.
Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials.
Participates in study specific training.
Actively participates in the preparation and coordination of investigator meetings and attends when required.
Manages study site activities and provides ongoing updates of site status to management.
Provides study status updates to management.
Develops patient enrollment strategies with the project team and study sites, as required.
Assists with interface with contract research organizations, as required.
Assists with interface with medical monitor and/or Clinical Events Committee for review of study data and adverse effects, as appropriate.
Assists with clinical report writing including interfacing with statistician to assure adequate statistical analysis and clinical progress reports.
Completes in-house monitoring activities as appropriate, such as updating in-house site files, and completing visit reports.
Maintains tracking records for assigned sites such as tracking of status and source document review per patient, as required.
Conducts and assists with Project specific administrative activities as a member of the project team.
Participates in feasibility activities and reports outcome to appropriate manager.
Continues to increase knowledge of medical device development process, Good Clinical Practices, and any applicable local regulatory requirements.
Participates in quality improvement efforts to increase overall operational efficiency eg assists in writing departmental procedures and training efforts.
Accurately completes administrative activities in a timely manner.
Other duties and assignments as requested for the overall performance of the Clinical Affairs Department and company.
When applicable provides clinical and technical support for junior CRAs and administrative staff as a mentor.
Responsible for representation of Blackstone Medical Inc. in a professional manner.

Regular attendance required.


ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS:

AA, RN, BS/BA or equivalent with at least 2 years clinical trial monitoring experience or experience as follows:

3 years of previously related health care or clinical research experience (eg study coordinator) and 2 years of clinical trial monitoring experience.
Previous practical experience in conducting clinical research studies in a hospital setting, medical device and/or pharmaceutical company, or CRO preferred. Experience or education indicates a sound basic knowledge of medical and medical device terminology.
Excellent verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language.
Ability to travel domestically and internationally as required and process visit reports and expense reports effectively.
Ability to work independently. Proficient in the use of computer and software systems.
Ability to understand basic and complex medical details.
Understanding of basic data processing functions preferred.
Knowledge of GCP and all applicable regulatory requirements preferred.

Required Experience
Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as computer, printer, copier, fax, and telephone. Occasionally required to reach overhead, bend, and lift objects (up to 20 lbs.).
Eyesight and hearing must be correctable to standard level.
Travel required.
Job Location
McKinney, TX, US.





Required Skills:

clinical monitoring exerience with pharmaceuticals or medical device

Job Category Keywords:
Medical device

Education Requirements:
Bachelors

Preferred Skills:
in house monitoring