Clark Davis Associates
Clinical Trial Associate - Consultant
Clark Davis Associates, Trenton, New Jersey, United States
Overview
Direct message the job poster from Clark Davis Associates Clinical Trial Associate - Consultant (No third parties or C2C)
This role is with a global pharmaceutical company located in NJ. Mandatory 3 days per week onsite Responsibilities
Coordinate meetings, including scheduling, agenda preparation, and minute-taking. Gather data for feasibility assessments and site selection, and maintain site usability records. Review study documents (e.g., informed consent forms, case report forms) in compliance with SOPs. Assemble and update study manuals and maintain version control of study materials. Monitor site activation, enrollment, and study progress, and escalate any issues or deviations. Maintain investigator and site status updates, and support clinical trial registry postings. Perform regular reconciliations of the Trial Master File (TMF). Ensure timely receipt of required reports (e.g., 1572 changes, financial disclosures). Manage team SharePoint or shared drive sites and maintain site contact information. Assist in managing third-party vendors and tracking study close-out activities. Participate in SOP revisions and propose process improvements. Qualifications
Strong attention to detail and ability to manage study activities effectively. Good communication and interpersonal skills. Problem-solving abilities and proactive approach to tasks. Familiarity with trial management systems and MS Office applications. Basic understanding of clinical drug development and ICH/GCP guidelines. Experience
Bachelor’s degree with 5+ years of relevant experience Seniority level
Associate Employment type
Contract Job function
Other Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Direct message the job poster from Clark Davis Associates Clinical Trial Associate - Consultant (No third parties or C2C)
This role is with a global pharmaceutical company located in NJ. Mandatory 3 days per week onsite Responsibilities
Coordinate meetings, including scheduling, agenda preparation, and minute-taking. Gather data for feasibility assessments and site selection, and maintain site usability records. Review study documents (e.g., informed consent forms, case report forms) in compliance with SOPs. Assemble and update study manuals and maintain version control of study materials. Monitor site activation, enrollment, and study progress, and escalate any issues or deviations. Maintain investigator and site status updates, and support clinical trial registry postings. Perform regular reconciliations of the Trial Master File (TMF). Ensure timely receipt of required reports (e.g., 1572 changes, financial disclosures). Manage team SharePoint or shared drive sites and maintain site contact information. Assist in managing third-party vendors and tracking study close-out activities. Participate in SOP revisions and propose process improvements. Qualifications
Strong attention to detail and ability to manage study activities effectively. Good communication and interpersonal skills. Problem-solving abilities and proactive approach to tasks. Familiarity with trial management systems and MS Office applications. Basic understanding of clinical drug development and ICH/GCP guidelines. Experience
Bachelor’s degree with 5+ years of relevant experience Seniority level
Associate Employment type
Contract Job function
Other Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr