The Fountain Group
We are a national staffing firm with an array of Fortune 500 clients and are currently seeking a
for a prominent client of ours. This position is located in
Basking Ridge, NJ . Job Details
Job Title:
Clinical Study Associate Pay:
$37 - $42.86 Duration:
1 year Job Schedule:
Candidate must be able to come onsite to Basking Ridge, NJ office 1-4 times a week. (Need to be local to NJ/NY) Description
Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Clients Quality Oversight measures. Support and assist the transmittal of trial and site level document to the Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the supervisor. Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Collect information and coordinate with Regulatory Operations to post trial information on required public forums (eg. clinicaltrials.gov). Works with Insurance Brokers to obtain study site Insurance Under the guidance of the转换ation Conclusion, analyze site metrics reports to identify potential areas of concern and bring to supervisor's attention. Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to the supervisor. Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices). Education
Bachelor's degree required. #LI-BS1
#J-18808-Ljbffr
for a prominent client of ours. This position is located in
Basking Ridge, NJ . Job Details
Job Title:
Clinical Study Associate Pay:
$37 - $42.86 Duration:
1 year Job Schedule:
Candidate must be able to come onsite to Basking Ridge, NJ office 1-4 times a week. (Need to be local to NJ/NY) Description
Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Clients Quality Oversight measures. Support and assist the transmittal of trial and site level document to the Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the supervisor. Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Collect information and coordinate with Regulatory Operations to post trial information on required public forums (eg. clinicaltrials.gov). Works with Insurance Brokers to obtain study site Insurance Under the guidance of the转换ation Conclusion, analyze site metrics reports to identify potential areas of concern and bring to supervisor's attention. Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to the supervisor. Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices). Education
Bachelor's degree required. #LI-BS1
#J-18808-Ljbffr