Careers

DESCRIPTION:

Responsible for site management and all applicable aspects, or designated areas, of a project.

REPORTS TO:
Director of Clinical Operations

RESPONSIBILITIES & ACCOUNTABILITIES

• Manages all clinical sites within delegated region for the entire scope of the study.
• Identifies project expectations and ensures required activities and documentation occur and are appropriately maintained.
• Operates within the project parameters while ensuring compliance with applicable regulatory, internal and project-specific requirements.
• May serve as the primary liaison with sponsor and sponsor-designated representatives.
• Communicates with either the sponsor (or designee) or directly with clinical sites to coordinate personnel training and equipment credentialing, as well as assessment of data transfer capabilities.
• Oversees project activities, ensures protocol adherence and addresses non-compliance issues, as appropriate.
• May write or contribute to standard operating procedure documentation.
• Provides the necessary training or coordinates with personnel, to provide clinical site training.
• May be required to travel for Investigator meetings, trainings, or other meetings/events per request
• Performs and/or participates in internal and external project-related audits and audit- related activities. Attends and/or presents at meetings with sponsors.
• Performs other departmental activities as needed and upon request.
• Able to work 40-60 +/- hours a month

EDUCATION & EXPERIENCE:

• Requires undergraduate degree or certificate, preferably in science, business or related field
• A minimum of 5 years of experience with Medical Device, Pharmaceutical and/or Clinical Research Industry, required.
• Working knowledge of regulations and standards related to clinical trial management for medical drugs and devices (such as GCP, FDA 21 CFR 320 and 812).
• Proficient in Microsoft Word, Excel, PowerPoint and experience using database software.
• Excellent written and oral communication skills.
• Excellent Organizational skills and attention to detail.
• Strong interpersonal skills and the ability to work with deadlines and manage multiple priorities.

To apply please send your CV with cover letter to hr@medqia.com and let us know why you feel you would be a great fit for this position, and asset to our team.

ROLE: Regional Clinical Coordinator II (Remote Independent Contractor) – Germany

DESCRIPTION: Responsible for site management and all applicable aspects, or designated areas, of a project within their region.

REPORTS TO: Director of Clinical Operations

RESPONSIBILITIES & ACCOUNTABILITIES

• Manages all clinical sites within delegated region for the entire scope of the study.
• Identifies project expectations and ensures required activities and documentation occur and are appropriately maintained.
• Operates within the project parameters while ensuring compliance with applicable regulatory, internal and project-specific requirements.
• May serve as the primary liaison with sponsor and sponsor-designated representatives.
• Communicates with either the sponsor (or designee) or directly with clinical sites to coordinate personnel training and equipment credentialing, as well as assessment of data transfer capabilities.
• Oversees project activities, ensures protocol adherence and addresses non-compliance issues, as appropriate.
• May write or contribute to standard operating procedure documentation.
• Provides the necessary training or coordinates with personnel, to provide clinical site training.
• May be required to travel for Investigator meetings, trainings, or other meetings/events per request
• Performs and/or participates in internal and external project-related audits and audit- related activities. Attends and/or presents at meetings with sponsors.
• Performs other departmental activities as needed and upon request.
• Able to work 40-60 +/- hours a month

EDUCATION & EXPERIENCE:

• Requires undergraduate degree or certificate, preferably in science, business or related field
• A minimum of 5 years of experience with Medical Device, Pharmaceutical and/or Clinical Research Industry, required.
• Working knowledge of regulations and standards related to clinical trial management for medical drugs and devices (such as GCP, FDA 21 CFR 320 and 812).
• Proficient in Microsoft Word, Excel, PowerPoint and experience using database software.
• Excellent written and oral communication skills.
• Excellent Organizational skills and attention to detail.
• Strong interpersonal skills and the ability to work with deadlines and manage multiple priorities.

To apply please send your CV with cover letter to Hr@Medqia.Com and let us know why you feel you would be a great fit for this position, and asset to our team.

ROLE: Regional Clinical Coordinator II (Remote Independent Contractor) – France

DESCRIPTION: Responsible for site management and all applicable aspects, or designated areas, of a project within their region.

REPORTS TO: Director of Clinical Operations

RESPONSIBILITIES & ACCOUNTABILITIES

• Manages all clinical sites within delegated region for the entire scope of the study.
• Identifies project expectations and ensures required activities and documentation occur and are appropriately maintained.
• Operates within the project parameters while ensuring compliance with applicable regulatory, internal and project-specific requirements.
• May serve as the primary liaison with sponsor and sponsor-designated representatives.
• Communicates with either the sponsor (or designee) or directly with clinical sites to coordinate personnel training and equipment credentialing, as well as assessment of data transfer capabilities.
• Oversees project activities, ensures protocol adherence and addresses non-compliance issues, as appropriate.
• May write or contribute to standard operating procedure documentation.
• Provides the necessary training or coordinates with personnel, to provide clinical site training.
• May be required to travel for Investigator meetings, trainings, or other meetings/events per request
• Performs and/or participates in internal and external project-related audits and audit- related activities. Attends and/or presents at meetings with sponsors.
• Performs other departmental activities as needed and upon request.
• Able to work 40-60 +/- hours a month

EDUCATION & EXPERIENCE:

• Requires undergraduate degree or certificate, preferably in science, business or related field
• A minimum of 5 years of experience with Medical Device, Pharmaceutical and/or Clinical Research Industry, required.
• Working knowledge of regulations and standards related to clinical trial management for medical drugs and devices (such as GCP, FDA 21 CFR 320 and 812).
• Proficient in Microsoft Word, Excel, PowerPoint and experience using database software.
• Excellent written and oral communication skills.
• Excellent Organizational skills and attention to detail.
• Strong interpersonal skills and the ability to work with deadlines and manage multiple priorities.

To apply please send your CV with cover letter to Hr@Medqia.Com and let us know why you feel you would be a great fit for this position, and asset to our team.

JOB TITLE: Imaging CRA I

DEPARTMENT: Clinical Operations

DESCRIPTION: Responsible for project team support and/or management of designated areas, for all aspects of clinical operations.

REPORTS TO:  Director of Clinical Operations

RESPONSIBILITIES & ACCOUNTABILITIES

• Manages all assigned clinical sites within delegated region for entire scope of study.
• May act as the Project Lead, managing all aspects of assigned projects or designated area.
• Identifies project expectations and ensures required activities and documentation occur and are appropriately maintained.
• Operates within the project parameters while ensuring compliance with applicable regulatory, internal and project-specific requirements.
• Ensures protocol adherence and addresses non-compliance issues, as appropriate.
• Participates in the writing of standard operating procedure documentation related to project management.
• Assists with identification and collection of departmental metrics.
• Assists with project billing related activities and requests
• Participates in the training of personnel and study sites and sponsors.
• May be required to host and/or present in operational meetings with sites and/or sponsor
• Responsible for preparing presentation and meeting materials and/or documentation.
• May serve as the primary liaison with sponsor and sponsor-designated representatives.
• May communicate directly with either the sponsor (or designee) or directly with clinical sites to coordinate personnel training and equipment credentialing, as well as assessment of data transfer capabilities.
• May be required to participate in internal and external project-related audits and audit-related activities.
• May be required to travel for Investigator meetings, trainings, or other meetings/events per request
• Performs other departmental activities as needed and upon request.

EDUCATION & EXPERIENCE

• Undergraduate degree or certificate in science, business, or related field preferred.
• At least 2-3 years of Medical Device, Pharmaceutical and/or within the Clinical Research Industry, preferred.
• Working knowledge of regulations and standards related to clinical trial management for medical drugs and devices (GCP, FDA 21 CFR 320 and 812, recommended).
• Proficient in Microsoft Word, Excel, PowerPoint and experience using database software.
• Excellent written and oral communication skills.

To apply please send your CV with cover letter to hr@medqia.com  and let us know why you feel you would be a great fit for this position, and asset to our team.

JOB TITLE: Image Analyst I

DEPARTMENT: Image Management

DESCRIPTION: Performs image import and quality control (QC) and prepares image data for analysis using the Company’s Imaging Biomarker Information System.

REPORTS TO: Director of Clinical Operations

RESPONSIBILITIES & ACCOUNTABILITIES:

• Performs image intake and preparation tasks based on priorities set by functional leads.
• Receives and imports image data into the Company database.
• Performs QC of image data and forms to ensure adherence with imaging parameters.
• Prepares image data for quantitative and visual image analysis.
• Extracts and records relevant information from clinical records and image data.
• Organizes and maintains databases, trackers and filing systems.
• Generates and reports image and output data questions and software anomalies.
• Proctors Clinical Readers during image read activities and ensures the progression of daily read.
• Assists with the operational management of studies as needed and upon request.
• Participates and presents at Company meetings as needed and upon request.
• Provides training and demonstrations on the use of the Company Information System.
• Participates output data review and resolution as needed and upon request.
• Participates in computer system acceptance testing as needed and upon request.
• Performs other departmental and study-related activities as needed and upon request.

EDUCATION & EXPERIENCE

• Requires undergraduate degree or certification, preferably in a science or medical-related field.
• Experience in a clinical research-related field, with familiarity of MRI, or CT/x-ray technology preferred.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Excellent written and oral communication skills.
• Strong interpersonal skills, organizational skills and attention to detail.
• Ability to work with deadlines and manage multiple priorities.

To apply for this position, please send us your CV with cover letter to hr@medqia.com