Talent.com
PSI
Site Management Associate II.PSI • Durham, NC, US
Site Management Associate II.

Site Management Associate II.

PSI • Durham, NC, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Start your career in clinical research, streamlining communication, maintaining systems and managing documents.

The scope of responsibilities will include:

  • Main site contact for all non-trial-participant related and non-protocol
    related issues, including vendors, trial supplies and access management
  • Manages records flow with sites and off-site facilities
  • Prepares regulatory and ethics committee submission/ notification
    documents and records
  • Coordinates payments to sites and off-site facilities
  • Prepares for and follows up on site audits and inspections
  • Reviews and coordinates site-specific query resolution with Monitors and
    sites
  • Reviews site-specific EDC completion progress and provides the Monitor
    with regular updates
  • Serves as the main contact point for other company departments in
    administrative site-related issues
  • Organizes, participates in, and prepares reports of internal project team
    meetings
  • Collaborates with sites and project team on Investigator Meetings'
    organization
  • Under supervision, provides on-the-job coaching of Site Management
    Associates I and Clinical Operations Administrative Support staff
  • Arranges and tracks initial and ongoing trial training for investigator site
    teams in all vendor-related systems
  • Provides training in courier management and trial supplies ordering to the
    investigator sites
  • Files trial records in the TMF and performs regular TMF checks on a site and country level
  • Participates in and follows up on TMF and systems audits
  • Prepares, distributes, and updates Investigator Site Files (ISF) and ISF
    checklists
  • Coordinates the translation process for trial records on a site and country
    level
  • Collects IP-REDs and compiles IP-RED packages for further review

Qualifications

  • College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.
  • Minimum 2 year experience within the clinical research industry, corporate or academic environment where administrative experience and technical skills have been gained.
  • Basic proficiency in MS Word.
  • Basic proficiency in MS Excel.
  • Basic proficiency in MS Outlook.
  • Basic proficiency in MS Power Point.
  • Knowledge (following proper training) of applicable software and project specific systems.
  • Basic typing skills in English (min. 40 words per minute)

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Create a job alert for this search

Site Management Associate II. • Durham, NC, US

Similar jobs

Storage Program Manager III

Hewlett Packard Enterprise Development LPDurham, NC, United States
Full-time

This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office.Hewlett Packard Enterprise is the global edge-to-cloud company advancing... Show more

 • Promoted

Director I- Field Service

AQUALISApex, North Carolina, United States
Full-time

Director of Field Service – Lead Multi-State Landscaping and Stormwater Operations.Salary/Pay Rate: $85,000 - $95,000 /Yr.Plus Quarterly Performance-Based Bonuses.Company Assigned Vehicle – 100% Ga... Show more

 • Promoted

Associate Director, Integrated Strategy

CloroxDurham, NC, United States
Full-time

Associate Director, Integrated Strategy.Clorox is the place that's committed to growth for our people and our brands.Guided by our purpose and values, and with people at the center of everything w... Show more

 • Promoted

client- P14 IReadiness Liaison

InstantServe LLCDurham, NC, United States
Full-time

The client requires the services of a readiness liaison to support change management and readiness for implementation of client Medicaid Transformation (Project 14) modules.Extensive statewide trav... Show more

 • Promoted

Director, Site Acquisition

Cypress Creek RenewablesDurham, NC, United States
Full-time

The energy industry is entering one of the most significant periods of growth and transformation in its history.Meeting the nation's growing demand for reliable electricity will require new ideas, ... Show more

 • Promoted

Banking Center Manager II

First Horizon Corp.Durham, NC, United States
Full-time

Location: On site at location listed in job posting.Schedule: Monday through Friday 9:00AM to 5:00PM, Saturday 9:00AM to 1:00PM Summary If you're a natural leader and want to lead a team at a str... Show more

 • Promoted

Director, Portfolio Deployment

IONNADurham, NC, United States
Full-time +1

Director, Portfolio Deployment.This role requires a full-time onsite presence in Durham, NC.Please note: We are only able to consider candidates who are U.The Director, Portfolio Deployment is resp... Show more

 • Promoted

Cost Representative II

Zachry GroupRoxboro, NC, United States
Full-time

The Cost Representative I&II represents a progressive career path within the Project Cost department.These roles are responsible for maintaining accurate earned value progress and actual cost data ... Show more

 • Promoted

Shared Site Project Execution

RIT SolutionsDurham, NC, United States
Full-time

Federal Electronic Health Records Modernization Leadership.Provide leadership and support the Federal Electronic Health Records Modernization (FEHRM) office in advancing the deployment of integrate... Show more

 • Promoted

NC DHHS Project Manager

IntersourcesDurham, NC, United States
Full-time

The NC Department of Health and Human Services (DHHS) is seeking an experienced Project Manager.This management role will work with multiple internal and external stakeholders, project teams, divis... Show more

 • Promoted

Inpatient Pharmacy Tech II Certified - OR

UNC Health CareChapel Hill, NC, US
Full-time

Your passion belongs at UNC Health.Join more than 56,000 teammates working together to improve the health and well-being of the communities we serve across North Carolina.The Certified Technician p... Show more

 • Promoted

Site Director, Clinical Risk Management

Duke HealthDurham, NC, United States
Full-time

Site Director Of Clinical Risk Management.At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community.No matte... Show more

 • Promoted

Assistant Manager - 2nd

Rack Room ShoesDurham, NC, United States
Full-time

The Assistant Manager assists the Store manager in managing all day to day store operations, while ensuring that compliance exists with all established company policies and procedures.Provides lead... Show more

 • Promoted

Site HSE Manager

NovartisDurham, NC, United States
Full-time

Manager, Health, Safety and Environment.The Manager, Health, Safety and Environment, is responsible for supporting the expansion of Durham campus operations to include Large Molecule drug substance... Show more

 • Promoted

Sales Associate III

Tapestry, Inc.Durham, NC, United States
Full-time

Coach is a global fashion house founded in New York in 1941.Inspired by the vision of Creative Director Stuart Vevers and the inclusive and courageous spirit of our hometown, we make beautiful thin... Show more

 • Promoted

Project Manager III

Chesapeake Utilities CorporationNC, United States
Full-time

Project Manager III Hybrid - must reside in Pennsylvania, Maryland, North Carolina, Virginia, Delaware, Ohio, Georgia, or Florida Your role in our success will be: This position plans, directs a... Show more

 • Promoted

Storage Program Manager III

Hewlett Packard EnterpriseDurham, NC, United States
Full-time

This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office.Hewlett Packard Enterprise is the global edge-to-cloud company advancing... Show more

 • Promoted

Banking Center Manager II

First HorizonDurham, NC, United States
Full-time

Location: On site at location listed in job posting.Schedule: Monday through Friday 9:00AM to 5:00PM, Saturday 9:00AM to 1:00PM.Summary: If you're a natural leader and want to lead a team at a stro... Show more

 • Promoted

Associate Manager

ExpressDurham, NC, United States
Full-time +1

Express is seeking an Associate Manager to join our team at Mall At Southpoint.The Associate Manager supports the store manager in managing store operations, recruiting, management, training and sa... Show more

 • Promoted

Site Budgeting and Contracting Specialist - FSP

FortreaDurham, NC, United States
Full-time +1

Budget Builder & Site Contract Specialist.Fortrea's FSP team is hiring Budget Builder & Site Contract Specialist! Home Based in USA or Canada.Must have 2+ years of budget/contract negotiation exper... Show more