What are the responsibilities and job description for the Clinical Trials Assistant position at RQMIS (Regulatory/Quality Management Information Source)?
Job Description
The Clinical Trials Assistant will work under the direction and supervision of Clinical Trials Project Manager(s). The CTA take responsibility for the timely and accurate completion of tasks supporting projects involving clinical studies. In addition, the CTA will provide training to clients and internal staff.
OVERALL RESPONSIBILITIES:
The Clinical Trial Assistant is responsible for assisting the study team in running the day to day operational activities of clinical studies. The individual’s primary focus will be responsible for the coordination, initial review and approval tracking of clinical study related invoicing. Secondary focus will be coordination and management of daily activities for multiple clinical studies to support both the internal team and client(s).
POSITION DUTIES & RESPONSIBILITIES:
Responsible for the timely completion of the following activities:
The physical demands described here are representative of those that must be met by a teammate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
No more than 30%
Company Description
RQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.
RQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.
The Clinical Trials Assistant will work under the direction and supervision of Clinical Trials Project Manager(s). The CTA take responsibility for the timely and accurate completion of tasks supporting projects involving clinical studies. In addition, the CTA will provide training to clients and internal staff.
OVERALL RESPONSIBILITIES:
The Clinical Trial Assistant is responsible for assisting the study team in running the day to day operational activities of clinical studies. The individual’s primary focus will be responsible for the coordination, initial review and approval tracking of clinical study related invoicing. Secondary focus will be coordination and management of daily activities for multiple clinical studies to support both the internal team and client(s).
POSITION DUTIES & RESPONSIBILITIES:
Responsible for the timely completion of the following activities:
- Protocol review to ensure seamless integration between clinical objectives and study performance
- Participate in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc
- Clinical study team member: works closely with the Clinical Project Manager and is responsible for coordination, tracking, and management of logistics in support of clinical trials
- Works closely with Study Manager and legal to review and approve confidentiality agreement, clinical trial agreements and site-specific study budgets
- Tracks study status, enrollment, regulatory documentation, and site start‐up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply
- Responsible for set‐up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files along with internal working file, as needed. Coordinates TMF transfer with CROs. These files include:
- Sponsor/Site correspondence
- Payments
- Device accountability
- IRB correspondence
- FDA/EU/other gov’t authority correspondence
- Research and Hospital Agreements
- Manages document control for clinical study related documents (e.g., protocol, CRFs, informed consent, etc.)
- Support and coordinate DSMB documentation, meetings, etc
- Participate in special projects as needed
- Organize material and finish the given material with required style, terminology, clarity and order
- Associate or Bachelor degree preferably in nursing, biology, biochemistry, or related areas is preferred but not required
- 2 years of experience in clinical research operations preferred
- Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and Premarket Applications (PMA) specifically for FDA Demonstrated ability to work independently with exceptional organization and attention to detail
- Strong computer skills, including Word, Excel, SharePoint, OneDrive, Visio and Adobe Professional and cloud based change control process software
- Excellent oral and written communication skills
- Good leadership skills
- Ability to effectively manage multiple tasks while continuously assessing company and/or departmental priorities
The physical demands described here are representative of those that must be met by a teammate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to, stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment, and interact/observe operations on a manufacturing floor
- Specific vision abilities required by this job include close vision requirements due to computer work and observing manufacturing processes
- Light to moderate lifting is required
- Ability to uphold the stress of traveling
- Regular, predictable attendance is required; including quarter-driven hours as business demands dictate
- Moderate noise (i.e. manufacturing environment, business office with computers, phone, and printers, light traffic)
- Ability to work in a confined area
- Ability to sit at a computer terminal for an extended period of time
No more than 30%
Company Description
RQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.
RQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.