Clinical Trial Associate - CEDENT
Boston, MA
About the Job
Job description
PURPOSE OF THE FUNCTION
As a member of the Clinical Trial Team (CTT), the Clinical Trial Associate Level 1 (CTA) will assist the Clinical Trial Managers (CTM) and other CTT functions if deemed necessary with the conduct of the assigned clinical trials, including the administration, coordination, and archival. This person will also assist with the inspection readiness of the electronic Trial Master File ([e]TMF) and provide support with study specific training, minute taking, creation/maintaining of trackers, and system access management for the CTT. In addition, the CTA will assist the Global Head of Trial Operations and Vice President of Global Clinical Operations with the logistics of the departmental meetings.
REPORTING LINE
• Trial Operations Excellence Manager
ROLES AND RESPONSIBILITIES
• Assist the CTM (and CTT if deemed necessary) with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Procedural Documents.
• Develop and adapt study documents to trial specific requirements in collaboration with the CTM.
• Assist with organizing trial specific meetings (agenda, meeting minutes, and action item management), including but not limited to trial team meetings and Investigator Meetings.
• Coordinate the filing of (e)TMF documents in the Electronic Clinical Operations system (ECO) by reviewing the completeness and document quality. Follow-up with the CTT on findings and provide support on how to use ECO correctly.
• Act as Business Administrator in ECO, by maintaining records and supporting close-out activities (including archival preparation). This includes managing study records, country records, and site records.
• Assist the CTM to ensure that the Trial Operations (e)TMF documents are made ready for archiving.
• Provide logistical support to the CTT on vendor (e)TMF oversight activities.
• Support the Global Head of Trial Operations and Vice President of Global Clinical Operations with the development of department template documents and the organization of the departmental meetings (agenda, meeting minutes, and action item management).
• Prepare trial reports for the CTT and keep them up-to-date.
• Collaborate with the CTM on advanced tasks such as reviewing vendor/sponsor plans and documents, coordinating trial insurances, reviewing submission packages, and attending CTA/CTM interviews.
• Support Clinical Development and Global Company initiatives as applicable.
SKILLS AND COMPETENCIES
• Speaks and writes English fluently
• Strong oral and written communication skills
• Good cross-cultural sensitivity
• Excellent organization skills with the ability to prioritize tasks
• Ability to work both independently and as part of a multidisciplinary team
EDUCATION, EXPERIENCE AND QUALIFICATIONS
• Bachelor’s degree or University degree – medical, para-medical, or equivalent by experience
• Minimum of 1 year of experience in a similar position within Clinical Operations
• Strong knowledge of International Conference on Harmonisation- Good Clinical Practice (ICH-GCP)
• Knowledge of Drug Information Association Trial Master File (DIA TMF) reference model
• Proficient in software applications such as Outlook, Word, Excel, PowerPoint, Teams
• Experience with at least one clinical trial management tool or system such as; Clinical Trial Management System, (e)TMF (Veeva Vault Clinical Operation), Electronic Case Report Form, or Interactive Response Technology system
At Cedent we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. Cedent is proud to be an equal opportunity employer.
PURPOSE OF THE FUNCTION
As a member of the Clinical Trial Team (CTT), the Clinical Trial Associate Level 1 (CTA) will assist the Clinical Trial Managers (CTM) and other CTT functions if deemed necessary with the conduct of the assigned clinical trials, including the administration, coordination, and archival. This person will also assist with the inspection readiness of the electronic Trial Master File ([e]TMF) and provide support with study specific training, minute taking, creation/maintaining of trackers, and system access management for the CTT. In addition, the CTA will assist the Global Head of Trial Operations and Vice President of Global Clinical Operations with the logistics of the departmental meetings.
REPORTING LINE
• Trial Operations Excellence Manager
ROLES AND RESPONSIBILITIES
• Assist the CTM (and CTT if deemed necessary) with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Procedural Documents.
• Develop and adapt study documents to trial specific requirements in collaboration with the CTM.
• Assist with organizing trial specific meetings (agenda, meeting minutes, and action item management), including but not limited to trial team meetings and Investigator Meetings.
• Coordinate the filing of (e)TMF documents in the Electronic Clinical Operations system (ECO) by reviewing the completeness and document quality. Follow-up with the CTT on findings and provide support on how to use ECO correctly.
• Act as Business Administrator in ECO, by maintaining records and supporting close-out activities (including archival preparation). This includes managing study records, country records, and site records.
• Assist the CTM to ensure that the Trial Operations (e)TMF documents are made ready for archiving.
• Provide logistical support to the CTT on vendor (e)TMF oversight activities.
• Support the Global Head of Trial Operations and Vice President of Global Clinical Operations with the development of department template documents and the organization of the departmental meetings (agenda, meeting minutes, and action item management).
• Prepare trial reports for the CTT and keep them up-to-date.
• Collaborate with the CTM on advanced tasks such as reviewing vendor/sponsor plans and documents, coordinating trial insurances, reviewing submission packages, and attending CTA/CTM interviews.
• Support Clinical Development and Global Company initiatives as applicable.
SKILLS AND COMPETENCIES
• Speaks and writes English fluently
• Strong oral and written communication skills
• Good cross-cultural sensitivity
• Excellent organization skills with the ability to prioritize tasks
• Ability to work both independently and as part of a multidisciplinary team
EDUCATION, EXPERIENCE AND QUALIFICATIONS
• Bachelor’s degree or University degree – medical, para-medical, or equivalent by experience
• Minimum of 1 year of experience in a similar position within Clinical Operations
• Strong knowledge of International Conference on Harmonisation- Good Clinical Practice (ICH-GCP)
• Knowledge of Drug Information Association Trial Master File (DIA TMF) reference model
• Proficient in software applications such as Outlook, Word, Excel, PowerPoint, Teams
• Experience with at least one clinical trial management tool or system such as; Clinical Trial Management System, (e)TMF (Veeva Vault Clinical Operation), Electronic Case Report Form, or Interactive Response Technology system
At Cedent we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. Cedent is proud to be an equal opportunity employer.
Source : CEDENT