לוח משרות דרושים מחקר ברפואה משרה מלאה, לחיפוש זה נמצאו 27 משרות

למרכז רפואי דרוש/ה מתאם/ת מחקר למכון למחלות הכבד למשרה מלאה
תיאור התפקיד:
השתתפות בפעילויות השיווק והמו"מ לקבלת מחקרים ליחידה
טיפול בתהליך אישור מחקר ביחידה
איתור וגיוס מטופלים פוטנציאלים למחקר, תיאום גיוס ע"י הרופאים, מתן הסבר והכוונה למועמדי המחקר
הכנות מנהלתיות לקבלת מטופלים לביצוע המחקר: תיאום וזימון תורים, הכנת חומרים וכלים, ארגון תהליך המחקר
תפעול שוטף של תהליך המחקר: קבלת מטופלים, תיווך בין גורמים רלוונטים, טיפול בדגימות וכו'
ניהול נתוני המחקר: ריכוז והזנת נתונים, הכנה ושליחת דיווחים, מתן מענה לפניות
קשרי עבודה עם גורמים רלוונטיים מחוץ לארגון: רשויות רגולטוריות, חברות תרופות, מכוני מחקר אחרים ועוד
טיפול שוטף בהיבטים מנהלתיים: כספים ותקציב, מלאי תרופות וציוד, ארכיב מחקר ועוד.

we are looking for a CTC/Sr CTC - FSP - EMEA.
As part of our global team, youll have the opportunity to provide administrative and technical support to the Project Team. As a Senior Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements.
What Youll Do:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
Provides system support (i.e. GoBalto & eTMF).
Supports RBM activities.
Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
Reviews and tracks local regulatory documents.
Transmits documents to client and centralized IRB/IEC.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Maintains vendor trackers.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
May attend Kick off meeting and take notes when required.

we are looking for a CRA I/II - FSP.
What Youll Do:
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
Participates in investigator meetings as necessary. Identifies potential
investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.

we are looking for a Manager, Medical Writing (Publications).
As part of our expert team, youll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Manager Medical Writing, you will manage the performance and workload of Medical Writers and provide short-term and long-term resource planning to assign projects to appropriate and available staff. You will supervise the preparation of Medical Writing deliverables and organize processes for the completion of projects within established timelines. You will evaluate the timeliness and quality of deliverables. You will assist writers in the presentation and interpretation of data and perform senior reviews to ensure overall adherence to departmental standards. Additionally, you will participate in the preparation and review of group SOPs and WPDs, evaluating compliance with SOP/WPD on an ongoing basis. You will give marketing presentations to potential clients on the capabilities of the Medical Writing department and interact with Bids and Contracts and Business Development to prepare budgets and proposals for Medical Writing projects. You will also participate in the development of training programs for Medical Writing and ensure direct reports are adequately trained.
What Youll Do:
Supervises Medical Writers. Provide short-term and long-term resource planning in order to assign projects to appropriate and available staff. Holds regularly scheduled meetings with staff and provide updates to senior management. Review and approve semimonthly time sheets. Assist staff to forecast project-related costs and timelines for completion. Hires and evaluates employees. Recommends salary levels and promotions
Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provides updates to senior management. Acts as resource for questions relating to study design, adverse event reporting, and statistical analyses. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental standards. Write and review group SOP and WPD. Evaluates compliance with SOP/WPD on an ongoing basis. Stays updated on relevant publication guidelines and requirements (GPP, ICMJE, etc.)
Gives marketing presentations to potential clients on the capabilities of the Medical Writing department. Interacts with Bids and Contracts and Business Development to prepare proposals for Medical Writing projects.
Develops and maintains training programs for Medical Writing. Ensures that all writers are adequately trained.
Uses scientific knowledge to assist in the written interpretation of scientific data and to guide others in their presentation of scientific data.

תאור התפקיד:
תפעול שוטף של מחקרים פנימיים וחיצוניים.
קשר עם מטופלים, חוקרים, מרכזים רפואיים וחברות בארץ ובחו"ל, ועבודה מול ועדת הלסינקי.
איסוף ותיעוד נתונים במאגרי מידע ממוחשבים.
טיפול בדגימות ביולוגיות (רקמות / דם / שתן).
היקף משרה:
משרה מלאה, א'-ה', 08:00-16:00 / 09:00-17:00.

תיאור התפקיד:
ניהול ישיר: הובלה, חניכה וניהול שוטף של צוות מתאמי.ות מחקר, כולל גיוס, הכשרה, משוב ובקרה על עבודתם.
אבטחת איכות (QA): וידוא עבודה קפדנית לפי נהלי GCP, משרד הבריאות, ועדת הלסינקי ופרוטוקולי המחקר של היזמים.
ניהול אופרטיבי: פיקוח על לוחות הזמנים, עמידה ביעדי גיוס מטופלים, וניהול הפן האדמיניסטרטיבי של הצוות.
ממשקים: עבודה צמודה מול הנהלת היחידה, רופאים, חברות הפארמה וגורמים פנימיים בביה"ח.
היקף משרה:
משרה מלאה, ימים א'-ה', 8:00-16:00 (גמיש)
נדרשת נכונות לשעות נוספות בעת הצורך.

תיאור תפקיד:
עבודה במחקרים פורצי דרך בתרופות ומכשור רפואי בתחום מחלות לב וצנתורים.
ניהול שוטף של מחקרים קליניים בכל הפאזות.
עבודה מול גורמים רבים בארץ ובחו"ל.
העבודה כוללת גיוס משתתפים, תיאום ביקורים ופרוצדורות, מילוי CRF, איסוף ותיעוד נתונים מגיליון רפואי, הזנת נתונים במאגרי מידע ממוחשבים, וכן הגשות לוועדת הלסינקי.
התפקיד כולל גם טיפול בדגימות ביולוגיות (רקמות, דם, שתן) ושימוש בציוד מעבדה (לא נדרש ידע או ניסיון קודם).
ליווי מטופלים ואיסוף מידע.
היקף משרה:
משרה מלאה, א'-ה'.
8 שעות עבוד ביום.