Labor Category : Clinical, Scientific and Laboratory Research Job Family : Clinical Studies Job Title : Clinical Research Specialist I (less than 5 years of experience) (Indirect) -- 6 MONTH CONTRACT Job Duties : Assists with successful conduct of assigned studies consistent with R&D and Marketing plans.,Assists in preparation of study materials and training of investigators, center staff and Medtronic field staff.,Writes monitoring plans.,Reviews clinical data/information and oversees data correction.,Assists study managers in providing interim and final reports and presentations.,Assists study manager in writing PMA Clinical Reports.,Reviews and approves center activation documents.,Work with the Clinical Study Manager to satisfy applicable regulatory standards.,Oversees, designs, plans, develops and monitors clinical evaluation projects.,Monitors and/or interprets results of clinical investigations in preparation for new drug application or device application. Skill Sets: Required: Education Level: Undergraduate Degree General Experience in a Clinical Study Research Environment: 1 - 3 Years Oral Communication: Excellent PC Experience : Data Entry PC Experience: Internet Usage Travel: 25-50% Travel Written Communication: Excellent General Experience in a Clinical Study Research Environment: 3 - 5 Years Knowledge of Medical Terminology: Knowledge of Medical Terminology Request Notes : CRA Position Responsibilities •Responsible for or assists with writing plans, strategy, and guidelines. Performs activities and generates reports for one or more significant subparts of the study (e.g.,monitoring,data management,adverse events, deaths,protocol deviations,legal agreements,study training, patient informed consents). •Develops or assists the study manager with the development of the required clinical documents (e.g.,Clinical Management Plan, Clinical Investigational Plan), study budget, project schedule, study training materials, and study reports in consultation with the cross-functional team, investigators, and the core clinical team. •Responsible for or assists with site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection. •Responsible for site monitoring (review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB, and Medtronic standards, guidelines and policies. •Ensure accurate inventory accountability of investigative product at assigned sites. •Prepare accurate and timely monitoring reports and follow action items through resolution. •Assists with writing of abstracts, manuscripts, and sections of reports. •May facilitate or assist with meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees. •May assist the Quality organization with project and investigator file audits. •Will ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc)and implement contingency plans as needed •Responsible for accurate and timely adverse event reporting during the study. •Will ensure site adherence to FDA, Regulatory, IRB and Medtronic requirements. •Work with investigators to quickly and effectively resolve problems. Requirements JOB EXPERIENCE •BS/BA with 2 years experience supporting clinical research. (i.e: industry sponsored clinical research, physician sponsored clinical research, government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance). Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable.•experience with clinical and outcomes research study design,Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals. Desired-BS with 3-4 years experience or advanced degree with 2 years ( 1 year monitoring experience) •Ability to coordinate study-planning efforts within the clinical department and with other business groups, including defining customer requirements and managing expectations •Ability to motivate and hold individuals accountable to deliverables; ability to achieve objectives and milestones. Proficient knowledge of medical terminology
