Senior Clinical Trial Associate
Joule4.1
Remote Rockville, MD
Job description
Job Title: Sr. Clinical Trial Associate
Location: Remote
Type: Direct Hire

Responsibilities:
Coordinates the logistical aspects of clinical trials according to Good Clinical Practice (GCP) and relevant SOP’s and acts as a pivotal point of contact for the clinical trial team.
Assists in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids)
Assists with preparation of training workshops, Investigator/Advisory Board meeting materials
Assists with all phases of clinical trial activities (e.g. start-up, conduct, and close-out)
Develops study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets)
Maintains tracking spreadsheets/databases and provides routine reports/dashboards to study team members
Requests PO independently, may review invoices with oversight from CPM
Tracks essential documents and maintains/reviews the eTMF under the guidance of a CRA of CPM.
Assists with management of investigational product and study supplies by ensuring the accuracy of shipments of study-related materials and collection of regulatory documents required for IP release
Participates in co-monitoring visits or other site visits based on experience and training provided by and under guidance of the sites’ assigned Clinical Research Associate (CRA) or designee
Assists the CRA with the flow of data, including but not limited to facilitating resolution of queries under guidance of CRA or Clinical Project Manager (CPM)
Assists with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 reports)
Assists with filing and management of the Electronic Trial Master File (eTMF)
Provides agendas, minutes, and action items for project team meetings
May assume a specialized administrative role (e.g. SOP Administrator)

Requirements:
Associates or Bachelor’s Degree with an emphasis on Life Sciences preferred
2 years’ applicable experience preferred, in a scientific or medical field.
Must have knowledge in reference to GCP/ICH and SOPs
Working knowledge and understanding of clinical protocols, and all other associated study related documents
Familiar with basic concepts of clinical research
Advanced knowledge of Word, Excel and Power Point
Knowledge of the principles and practices of computer applications in database management
Must have a high degree of customer focus toward internal and external stakeholders
Must display strong analytical and problem-solving skills
Strong interpersonal and collaboration skills
Attention to detail required

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
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Company details

Employee

501 to 1000

Company Description
Impacting lives. It’s in our DNA. At Joulé, we believe our world is filled with possibilities – where character, integrity, and commitment drive our purpose. For over 30 years, Joulé has been a trusted partner to industry leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent. Operating at the forefront of the life sciences arena, Joulé’s relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects. Joulé is a System One division.
Company ratings
  • Overall
    4.1
  • Company & Benefits
    3.4 / 5
  • Culture & Values
    3.7 / 5
  • Career Opportunities
    3.1 / 5
  • Work/Life Balance
    3.6 / 5
  • Senior Management
    3.6 / 5
Company reviews
"Simple job"
Former EmployeeIntern
I had a simple job to do. Was boring and no one really paid any attention to me. It seemed like they had multiple locations and everyone was really disconnected.
Pros:
Cons:

"learned a lot. came in green with weld certs"
Former EmployeeMillwright
lower management were idiots. just show up and work. great place to learn the trade. ill see a a lot of different things. just keep your safety first do not let anyone change that.

"It was a great job i enjoyed working there."
Former EmployeeParking Attendant
they had issues working around my school schedule mostly because they were short staffed only having 2 other valet cashiers and if we were busy sometimes id have to go in on short notice. i enjoyed the work environment, the coworkers, and on my first day it was a welcoming experience. the training was fairly easy and i felt very secure since we had security and armed cops incase something happened. since the hotel was downtown we had to on the lookout for homeless people entering the hotel or over intoxicated people causing issues for others.

"Amazing"
Current EmployeePeople ready
I worked for joule for a week through a temp and it was the best job I’ve ever worked for , the whole operation was amazing we had a few mix ups throughout the project but the main goal was met mostly every day