Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Clinical Study Coordinator
177 County Road B East St. Paul, MN 55117 US
Posted: 09/08/2023
2023-09-08
2023-10-20
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 585021
Is job remote?: No
Country: United States
Job Description
Target PR Range: 20-30/hr
*Depending on experience
Position Summary: Briefly state the main purpose and scope of the position.
Working under direct supervision, provide clinical study administrative support to ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards and SJM Standard Operating Procedures. Performs routine assignments in this entry level position. Focus is on supporting administrative functions related to clinical study(s) which may include maintaining Clinical Trial Master File, site regulatory documents and device shipping and tracking. Assist with the coordination of safety board meetings which may include preparation of documents, coordination of meeting venue and travel. Provide assistance with core labs which includes tracking receipt of test results and invoices.
Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform.
1. File Management
x Set-up and maintain Clinical Trial Master File.
x Set-up and maintain site study files.
x Maintain source document files.
.
2. Provide support to Clinical Project Teams
x Assist with preparation for monitoring visits, such as internal regulatory file reviews and preparation, as appropriate for the assigned study.
x Maintain records of investigational devices for all assigned regulated studies.
x Facilitate the order and release of clinical IDE device inventory.
x Process invoices as needed and review payment report if applicable.
x Run IRB renewal status report and notify sites of pending IRB renewals.
x Create site regulatory/subject binder(s) and ship to sites.
x Assist with collection of site activation documents.
x Organize and track shipment of study related documents.
x Support and track shipment of project related equipment/data between centers, sponsor and core labs.
x Assist with core labs such as tracking receipt of test results and invoices.
x Attend project related meetings; write meeting minutes as applicable.
x Assist with Investigator/Committee, etc. meetings such as travel arrangements, hotel,
conference rooms, etc.
x Collect, file and de-identify adverse event source documents.
x Receive and file study related documents in the appropriate location.
Position Description
3. Able to handle multiple assignments in a timely manner while meeting assigned deadlines.
4. Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
Other Duties: List any other important but non-essential and/or infrequent duties performed.
x Support all Divisional initiatives as identified by divisional management and in
support of Quality Management Systems (QMS), Environmental Management
Systems (EMS), and other regulatory requirements.
Equipment: List the type of equipment the incumbent in this position is required to work with.
Uses standard office equipment, including (but not limited to) personal computer, telephone, FAX, and copier.
Working Conditions: Describe the work environment characteristics representative of those encountered
by an employee performing the essential functions of this job.
Normally works in a cubicle situated in open landscape office environment. Air conditioned.
Well lighted. Moderate noise level.
Physical Demands: Describe the physical demands representative of those that must be met by an employee to successfully perform the essential functions of this job.
Primarily sitting. Some walking. Light effort related to moving, lifting and using office supplies and standard office items. Performs tasks which regularly require good correctable vision and hand/eye coordination.
Qualifications:
Required: High school diploma/secondary school degree.
Proficient in operating a personal computer and in using various PC-based
software packages including Microsoft Word, Excel, or similar word
processing/spreadsheet software.
Must have strong organizational skills and attentiveness to detail.
Must also have verbal and written communication, interpersonal, organizational
and basic math skills.
The ability to read, write, and communicate effectively in English is also required;
this requirement includes clear, understandable speech, demonstrated
comprehension skills, and demonstrated competence in English spelling, grammar
and punctuation.
Must be able to use discretion and handle sensitive/confidential information.
The ability to work independently when necessary.
Position Description
The ability to exchange straightforward information, ask questions, and check for
understanding.
Must be able to maintain regular and predictable attendance.
Desired: A Bachelor’s degree from an accredited university or college.
A general familiarity with cardiac, vascular, and/or neuromodulation
technologies, and clinical research processes. Previous related experience in a
medical device/pharmaceutical company or relevant clinical experience in a
clinical/hospital environment.
Previous Customer Service experience including interacting with customers,
answering customer questions and providing information.
Â
*Depending on experience
Position Summary: Briefly state the main purpose and scope of the position.
Working under direct supervision, provide clinical study administrative support to ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards and SJM Standard Operating Procedures. Performs routine assignments in this entry level position. Focus is on supporting administrative functions related to clinical study(s) which may include maintaining Clinical Trial Master File, site regulatory documents and device shipping and tracking. Assist with the coordination of safety board meetings which may include preparation of documents, coordination of meeting venue and travel. Provide assistance with core labs which includes tracking receipt of test results and invoices.
Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform.
1. File Management
x Set-up and maintain Clinical Trial Master File.
x Set-up and maintain site study files.
x Maintain source document files.
.
2. Provide support to Clinical Project Teams
x Assist with preparation for monitoring visits, such as internal regulatory file reviews and preparation, as appropriate for the assigned study.
x Maintain records of investigational devices for all assigned regulated studies.
x Facilitate the order and release of clinical IDE device inventory.
x Process invoices as needed and review payment report if applicable.
x Run IRB renewal status report and notify sites of pending IRB renewals.
x Create site regulatory/subject binder(s) and ship to sites.
x Assist with collection of site activation documents.
x Organize and track shipment of study related documents.
x Support and track shipment of project related equipment/data between centers, sponsor and core labs.
x Assist with core labs such as tracking receipt of test results and invoices.
x Attend project related meetings; write meeting minutes as applicable.
x Assist with Investigator/Committee, etc. meetings such as travel arrangements, hotel,
conference rooms, etc.
x Collect, file and de-identify adverse event source documents.
x Receive and file study related documents in the appropriate location.
Position Description
3. Able to handle multiple assignments in a timely manner while meeting assigned deadlines.
4. Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
Other Duties: List any other important but non-essential and/or infrequent duties performed.
x Support all Divisional initiatives as identified by divisional management and in
support of Quality Management Systems (QMS), Environmental Management
Systems (EMS), and other regulatory requirements.
Equipment: List the type of equipment the incumbent in this position is required to work with.
Uses standard office equipment, including (but not limited to) personal computer, telephone, FAX, and copier.
Working Conditions: Describe the work environment characteristics representative of those encountered
by an employee performing the essential functions of this job.
Normally works in a cubicle situated in open landscape office environment. Air conditioned.
Well lighted. Moderate noise level.
Physical Demands: Describe the physical demands representative of those that must be met by an employee to successfully perform the essential functions of this job.
Primarily sitting. Some walking. Light effort related to moving, lifting and using office supplies and standard office items. Performs tasks which regularly require good correctable vision and hand/eye coordination.
Qualifications:
Required: High school diploma/secondary school degree.
Proficient in operating a personal computer and in using various PC-based
software packages including Microsoft Word, Excel, or similar word
processing/spreadsheet software.
Must have strong organizational skills and attentiveness to detail.
Must also have verbal and written communication, interpersonal, organizational
and basic math skills.
The ability to read, write, and communicate effectively in English is also required;
this requirement includes clear, understandable speech, demonstrated
comprehension skills, and demonstrated competence in English spelling, grammar
and punctuation.
Must be able to use discretion and handle sensitive/confidential information.
The ability to work independently when necessary.
Position Description
The ability to exchange straightforward information, ask questions, and check for
understanding.
Must be able to maintain regular and predictable attendance.
Desired: A Bachelor’s degree from an accredited university or college.
A general familiarity with cardiac, vascular, and/or neuromodulation
technologies, and clinical research processes. Previous related experience in a
medical device/pharmaceutical company or relevant clinical experience in a
clinical/hospital environment.
Previous Customer Service experience including interacting with customers,
answering customer questions and providing information.
Â
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