The Fountain Group
Hello,My name is Arnold, and I am a Senior Talent Acquisition Consultant with The Fountain Group.
We are a national staffing firm with an array of Fortune 500 clients constantly looking for candidates such as yourself to join the team.
I believe you have a great background andwould love to discuss what's most important to you then compared to see if it matches our job.
Currently I have an opening for Site Monitoring Lead located in Ridgefield, CT (Remote).
Details for the position are as follows:
Pay rate:
$87.
25/hr.
($3,489/weekly)Job Description/
Responsibilities:
Title :
Clinical Site Monitoring LeadTrial Preparation:
Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials ( 5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study.
Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs working on assigned trials.
Implement the monitoring plan as part of the Trial Team.
Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s)(e.
g.
BI CTMS).
Deliver Risk-based Site Monitoring approach and local training for the trial.
Develop and provide appropriate training of local trial teams (e.
g.
Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA)).
Assist with in-house Site Monitoring inspection readiness activities and lead preparation for US site regulatory inspections, as requested.
Behave as local expert and consultant on site management and monitoring topics.
Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.
Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee).
Trial Conduct:
Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.
Issue management / oversight on country level.
Continuous review, risk identification, evaluation/ analysis and communication on a country level as applicable.
Maintain Risk-based Site Monitoring approach for the OPU and provide feedback on the trends identified that may impact the TLMM and/or site monitoring oversight plan.
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) at OPU according to plan, implement follow-up actions and escalation, as required.
In conjunction with SML-r, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed.
In conjunction with SML-r, facilitate communication and training related to site monitoring in the trial at the OPU:
Communication and training of CT Managers and CRAs.
Performing re- training as necessary.
Participate, prepare input (as requested by SML-r) for Trial Oversight Meetings (country level) and contribute to the timely responses to questions from external and internal stakeholders.
Qualifications:
Bachelor's Degree (Health Sciences, Health Care, Nursing or Others) required5 years of experience performing on-site monitoring or 8 years of relevant business experience in the regulated pharmaceutical or healthcare industry, including on-site monitoring experience.
PMP Certification highly preferredOncology, metabolic, Dermatology, CNS experiecnePROJECT MANAGEMENTCAPARISK ASSESSMENTCLINICAL TRIAL MONITORING Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients.
Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards.
Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group4505 Woodland Corporate Blvd, Tampa, FL 33614We work in Life Sciences, Clinical, Engineering, IT, and more.
Above all, we specialize in people.
If you are interested in hearing more about this position or other opportunities I may have please respond to this posting with your updated resume or contact me at (813) 425-2220, please reply/email your resume directly to Arnold.
Suwan@TheFountainGroup.
comPlease forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.
About the Company:
The Fountain GroupThe Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program.
The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner.
We base this on the premise that a company is much more than the products it offers.
The effect a company has on the environment, the people and the communities it serves reflects the company's dedication to being not only a good business, but to being a good corporate citizen.
The Fountain Group believes the key to servicing a client is to identify the client demand precisely.
Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client's needs.
Our process utilizes modern technology combined with 30
years of Talent Acquisition experience to deliver Precision resources.
Financial strength is prominent among The Fountain Group's corporate values.
The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Company Size:
500 to 999 employeesIndustry:
Staffing/Employment AgenciesFounded:
0Website:
https:
//www.
thefountaingroup.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
We are a national staffing firm with an array of Fortune 500 clients constantly looking for candidates such as yourself to join the team.
I believe you have a great background andwould love to discuss what's most important to you then compared to see if it matches our job.
Currently I have an opening for Site Monitoring Lead located in Ridgefield, CT (Remote).
Details for the position are as follows:
Pay rate:
$87.
25/hr.
($3,489/weekly)Job Description/
Responsibilities:
Title :
Clinical Site Monitoring LeadTrial Preparation:
Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials ( 5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study.
Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs working on assigned trials.
Implement the monitoring plan as part of the Trial Team.
Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s)(e.
g.
BI CTMS).
Deliver Risk-based Site Monitoring approach and local training for the trial.
Develop and provide appropriate training of local trial teams (e.
g.
Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA)).
Assist with in-house Site Monitoring inspection readiness activities and lead preparation for US site regulatory inspections, as requested.
Behave as local expert and consultant on site management and monitoring topics.
Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.
Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee).
Trial Conduct:
Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.
Issue management / oversight on country level.
Continuous review, risk identification, evaluation/ analysis and communication on a country level as applicable.
Maintain Risk-based Site Monitoring approach for the OPU and provide feedback on the trends identified that may impact the TLMM and/or site monitoring oversight plan.
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) at OPU according to plan, implement follow-up actions and escalation, as required.
In conjunction with SML-r, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed.
In conjunction with SML-r, facilitate communication and training related to site monitoring in the trial at the OPU:
Communication and training of CT Managers and CRAs.
Performing re- training as necessary.
Participate, prepare input (as requested by SML-r) for Trial Oversight Meetings (country level) and contribute to the timely responses to questions from external and internal stakeholders.
Qualifications:
Bachelor's Degree (Health Sciences, Health Care, Nursing or Others) required5 years of experience performing on-site monitoring or 8 years of relevant business experience in the regulated pharmaceutical or healthcare industry, including on-site monitoring experience.
PMP Certification highly preferredOncology, metabolic, Dermatology, CNS experiecnePROJECT MANAGEMENTCAPARISK ASSESSMENTCLINICAL TRIAL MONITORING Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients.
Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards.
Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group4505 Woodland Corporate Blvd, Tampa, FL 33614We work in Life Sciences, Clinical, Engineering, IT, and more.
Above all, we specialize in people.
If you are interested in hearing more about this position or other opportunities I may have please respond to this posting with your updated resume or contact me at (813) 425-2220, please reply/email your resume directly to Arnold.
Suwan@TheFountainGroup.
comPlease forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.
About the Company:
The Fountain GroupThe Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program.
The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner.
We base this on the premise that a company is much more than the products it offers.
The effect a company has on the environment, the people and the communities it serves reflects the company's dedication to being not only a good business, but to being a good corporate citizen.
The Fountain Group believes the key to servicing a client is to identify the client demand precisely.
Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client's needs.
Our process utilizes modern technology combined with 30
years of Talent Acquisition experience to deliver Precision resources.
Financial strength is prominent among The Fountain Group's corporate values.
The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Company Size:
500 to 999 employeesIndustry:
Staffing/Employment AgenciesFounded:
0Website:
https:
//www.
thefountaingroup.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
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