Clinical Trials Management Associate - I

Company: Calsoft Labs
Location: Santa Monica
Posted on: March 13, 2023

Job Description:

Responsibilities include but, are not limited to:

May assist in the review of study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manger (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
With guidance, plays a direct role in clinical studies execution, such as managing components of studies and acting as a member of the study team
Manage vendors
Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met.
Attends internal team and other meetings as required.
Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences.
Creates and reviews site feasibility assessments required for study participation.
Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.
Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager.
Prepares metrics and updates to key deliverables for management.
Assists in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks.
Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team
Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
May participate in special projects
Familiar with standard medical / scientific terminology
Other duties as assigned.

Basic Qualifications:

BS/BA/RN in nursing, science or health field with 1+ years of related experience

Preferred Qualifications

Oncology/Hematology experience considered a plus
Willing/Able to travel at least 25% (possibly more)
Ability to manage time demands, incomplete information or unexpected events
Display strong analytical and problem solving skills
Attention to detail
Outstanding organizational skills with the ability to multi-task and prioritize
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Working knowledge of transplant patient care and apheresis collection a plus

Keywords: Calsoft Labs, Santa Monica , Clinical Trials Management Associate - I, Healthcare , Santa Monica, California