Job Postings
AMDM posts open positions within the IVD Industry.
The charges for a 60-day posting for AMDM Members are $150 (Pay via our secure online store), and $300 for Non-Members. AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description with contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
The charges for a 60-day posting for AMDM Members are $150 (Pay via our secure online store), and $300 for Non-Members. AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description with contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
Posted 7.24.19
Regulatory & Clinical Research Institute, Inc.
5353 Wayzata Blvd., Suite 505
Minneapolis, MN 55416-1334
Position: Clinical Project Manager
Full Time, Minneapolis, MN, US
POSITION SUMMARY:
• Assists clients with all aspects of clinical study management.
DESCRIPTION OF RESPONSIBILITIES & AUTHORITIES:
• Assists with clinical protocol/study design and strategy. • Reviews protocols for regulatory and SOP compliance.
• Designs CRFs, CRF guidelines and all other study documents.
• Manages all aspects of clinical studies, including trial conduct, and staff oversight and training.
• Develops and maintains project timelines and budget with sponsor and core lab/vendors.
• Interacts with the Health Informatics group to ensure database build/updates per client specifications.
• Tracks study enrollment goals and reports progress to study team/sponsor.
• Analyzes and reports all study issues to supervisor and sponsor.
• Identifies/qualifies/trains investigators, sites, and site staff.
• Oversees data validation efforts, including plan and report generation, staff training, validation oversight and corrections.
• Manages study sites
• Manages DSMB/CECs, including member identification/qualification, SOP and Plan development, meeting preparation, management and follow-up.
• Assists with clinical report generation.
• Ensures compliance with RCRI and applicable sponsor SOPs.
• Actively markets RCRI services to current and potential clients.
• Delivers one internal training session per year.
• Attends applicable internal and external training programs each year.
MINIMUM POSITION QUALIFICATION REQUIREMENTS:
• Science or health-related bachelor’s degree (or equivalent experience).
• Minimum of four years of IVD clinical study experience preferred.
• Excellent communication and interpersonal skills.
• Strong organizational skills and detail oriented.
• Ability to travel 20% time preferred.
Applicants may apply online by clicking here.
Regulatory & Clinical Research Institute, Inc.
5353 Wayzata Blvd., Suite 505
Minneapolis, MN 55416-1334
Position: Clinical Project Manager
Full Time, Minneapolis, MN, US
POSITION SUMMARY:
• Assists clients with all aspects of clinical study management.
DESCRIPTION OF RESPONSIBILITIES & AUTHORITIES:
• Assists with clinical protocol/study design and strategy. • Reviews protocols for regulatory and SOP compliance.
• Designs CRFs, CRF guidelines and all other study documents.
• Manages all aspects of clinical studies, including trial conduct, and staff oversight and training.
• Develops and maintains project timelines and budget with sponsor and core lab/vendors.
• Interacts with the Health Informatics group to ensure database build/updates per client specifications.
• Tracks study enrollment goals and reports progress to study team/sponsor.
• Analyzes and reports all study issues to supervisor and sponsor.
• Identifies/qualifies/trains investigators, sites, and site staff.
• Oversees data validation efforts, including plan and report generation, staff training, validation oversight and corrections.
• Manages study sites
• Manages DSMB/CECs, including member identification/qualification, SOP and Plan development, meeting preparation, management and follow-up.
• Assists with clinical report generation.
• Ensures compliance with RCRI and applicable sponsor SOPs.
• Actively markets RCRI services to current and potential clients.
• Delivers one internal training session per year.
• Attends applicable internal and external training programs each year.
MINIMUM POSITION QUALIFICATION REQUIREMENTS:
• Science or health-related bachelor’s degree (or equivalent experience).
• Minimum of four years of IVD clinical study experience preferred.
• Excellent communication and interpersonal skills.
• Strong organizational skills and detail oriented.
• Ability to travel 20% time preferred.
Applicants may apply online by clicking here.
Posted 7.17.19
Regulatory & Clinical Research Institute, Inc.
5353 Wayzata Blvd., Suite 505
Minneapolis, MN 55416-1334
JOB OPENING TITLE Senior Regulatory Affairs Principal Advisor
JOB-0339
DEPARTMENT NAME:
Regulatory Affairs and Quality Systems
POSITION SUPERVISOR:
See current Organizational Chart
POSITION SUMMARY:
Serves as a senior strategic consultant and subject matter expert for client services. Key liaison between clients and regulatory bodies in matters of policy. Works independently as well as in collaboration with Business Development to identify and solicit potential clients. Develops internal training programs and/or mentors junior RCRI staff.
DESCRIPTION OF RESPONSIBILITIES & AUTHORITIES:
· Provides leadership as a project advisor internally to RCRI teams and as a project director externally to clients.
· Serves as a senior, strategic consultant to RCRI clients and RCRI staff.
· Acts as a liaison between clients and regulatory agencies in matters of policy interpretation and implementation.
· Serves as a subject matter expert.
· Provides internal guidance to ensure that departmental services meet industry expectations, and governmental regulations.
· Interacts with clients and potential clients throughout all levels of industry and corporate management.
· Identifies and solicits potential clients.
· Represents RCRI to outside industry affiliations and organizations.
· Actively works and maintains industry contacts and professional network.
· Mentors staff in topics for which they are a subject matter expert.
· Represents and assists in the marketing of RCRI capabilities and services to potential and current clients through marketing meetings, presentations, attending pertinent trade shows, seminars, conferences, etc.
· Develops and conducts internal (RCRI) training in areas of expertise.
· Other duties as assigned.
MINIMUM POSITION QUALIFICATION REQUIREMENTS:
PHYSICAL REQUIREMENTS:
If requested by an employee and in accordance with applicable law, RCRI provides reasonable accommodation to known physical or mental limitations of an otherwise qualified employee with a disability to allow him/her to perform the essential functions of the job.
Applicants may apply online by clicking here.
Regulatory & Clinical Research Institute, Inc.
5353 Wayzata Blvd., Suite 505
Minneapolis, MN 55416-1334
JOB OPENING TITLE Senior Regulatory Affairs Principal Advisor
JOB-0339
DEPARTMENT NAME:
Regulatory Affairs and Quality Systems
POSITION SUPERVISOR:
See current Organizational Chart
POSITION SUMMARY:
Serves as a senior strategic consultant and subject matter expert for client services. Key liaison between clients and regulatory bodies in matters of policy. Works independently as well as in collaboration with Business Development to identify and solicit potential clients. Develops internal training programs and/or mentors junior RCRI staff.
DESCRIPTION OF RESPONSIBILITIES & AUTHORITIES:
· Provides leadership as a project advisor internally to RCRI teams and as a project director externally to clients.
· Serves as a senior, strategic consultant to RCRI clients and RCRI staff.
· Acts as a liaison between clients and regulatory agencies in matters of policy interpretation and implementation.
· Serves as a subject matter expert.
· Provides internal guidance to ensure that departmental services meet industry expectations, and governmental regulations.
· Interacts with clients and potential clients throughout all levels of industry and corporate management.
· Identifies and solicits potential clients.
· Represents RCRI to outside industry affiliations and organizations.
· Actively works and maintains industry contacts and professional network.
· Mentors staff in topics for which they are a subject matter expert.
· Represents and assists in the marketing of RCRI capabilities and services to potential and current clients through marketing meetings, presentations, attending pertinent trade shows, seminars, conferences, etc.
· Develops and conducts internal (RCRI) training in areas of expertise.
· Other duties as assigned.
MINIMUM POSITION QUALIFICATION REQUIREMENTS:
- Advanced degree in a scientific or technical field is required. Professional certification (i.e. RAC) desirable. Experience of at least 15 years in a regulatory affairs capacity in lieu of the advanced degree will be considered.
- Minimum of twelve years of experience in medical device companies.
- History of cooperative working relationships with regulatory agencies or scientific associations/committees desired.
- Expertise in more than one area of RCRI services is highly desirable.
- Must have demonstrated proficiency in area of expertise by publishing, lecturing, serving on expert committees, or by work history.
- Demonstrates a professional demeanor that promotes superior work performance.
- Superior oral and written communication skills; must feel comfortable writing, speaking and presenting to a variety of audiences
- Effective interpersonal skills.
- Strong organizational skills and detail-orientation.
- Demonstrated abilities to communicate cross-functionally throughout organizations.
- Familiarity with basic computer applications, e.g., Word, PowerPoint.
- Ability to travel up to 25% of the time.
PHYSICAL REQUIREMENTS:
If requested by an employee and in accordance with applicable law, RCRI provides reasonable accommodation to known physical or mental limitations of an otherwise qualified employee with a disability to allow him/her to perform the essential functions of the job.
Applicants may apply online by clicking here.