Clinical Project Associate, Sarah Cannon Research Institute - Nashville, TN at Nashville

Job Description

Job: Supervisors Team Leaders & Coordinators

Sarah Cannon Research Institute (SCRI) is a global strategic research organization focusing on advancing therapies and accelerating drug development. It is one of the largest clinical research programs, conducting community-based clinical trials in oncology and cardiology through affiliations with a network of more than 700 physicians in the United States and United Kingdom. Additionally, SCRI offers management, regulatory and other research support services to drug development sponsors and strategic investigator sites.
Summary of Key Responsibilities:
Performs investigator site recruitment/feasibility, critical documentation collection and review, clinical status tracking to ensure metrics are met as well as standard operating procedures, ICH-GCP, and all applicable regulatory requirements are adhered to.
Duties and Responsibilities:
Assists with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial and assess site adherence to Good Clinical Practice (GCP).
Performs critical document distribution to and collection from the investigators and investigative sites throughout the conduct of the clinical trial.
Performs tracking to ensure that the clinical trial files are accurate, current and complete and follows up with sites to receive missing documentation.
Tracks IRB renewal dates.
Assists Project Manager (PM) or Clinical Research Associate (CRA) with appropriate study-related documents and administrative support.
Maintains clinical trial monitoring/management tracking systems, i.e., Siebel Clinical
Archives site/study specific regulatory documents and correspondence.
Maintains central and investigative files in collaboration with Regulatory Affairs.
Initiates improvements to enhance the efficiency and the quality of the work performed on assigned projects.
Communicates and escalates unresolved issues at the appropriate time and to the appropriate level of management.
Generates meeting minutes as required.
Assists with planning and conducting investigator meetings.
Assists with vendor management.
Assists with study start up activities, SIV, RMV and close-out visits.
Attends project meetings, conference calls and monthly staff meetings, as required.
Adheres to professional standards and SOPs established for clinical research.
KNOWLEDGE, SKILLS & ABILITIES This position requires the following minimal requirements:
Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, MS Access or Excel
Excellent professional writing and communication skill
Highly organized; ability to handle multiple priorities efficiently
Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment
Excellent interpersonal skills, detailed-oriented and meticulous

Job Requirements

EDUCATION:
High School Diploma/GED is required; Bachelors degree is preferred
REQUIRED EXPERIENCE:
1-3 years of directly-related experience is required
PREFERRED EXPERIENCE:
1-3 years experience in clinical trial environment, healthcare research, regulated-science field, or similarLICENSURE/CERTIFICATION:
CCRP or other Research Professional certification preferred
Country: USA, State: Tennessee, City: Nashville, Company: Sarah Cannon Research Institute.