Clinical Study Associate I Job at Planet Group, Basking Ridge, NJ

UGEwRlZVZk81a2RQM0h2R1dxTlE5SzZIdkE9PQ==
  • Planet Group
  • Basking Ridge, NJ

Job Description

Target Pay Rate: 35-40/hr **salary will be commensurate with experience 

Job Description:
  • Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
  • Key focus is on providing clinical administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Quality Oversight measures.
  • Support and assist the transmittal of trial and site level document to the DS Document Control Center (DCC) in support of the Trial master File (TMF).
  • Reconcile the TMF document trackers generated by the CRO with the document archive.
  • Bring issues with the reconciliation to the attention of the supervisor.
  • Provide clinical administrative support to the study teams.
  • This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.
  • Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).
  • Works with Insurance Brokers to obtain study site Insurance Under the guidance of the supervisor, analyze site metrics reports to identify potential areas of concern and bring to supervisors attention.
  • Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to the supervisor.
  • Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).
Skills:
  • Minimum of 1-year relevant experience is required.
  • Veeva experience is a plus.
  • Oncology experience is a plus.
  • Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO).
  • Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
  • Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills.
Education:
  • Bachelor's degree required

Job Tags

Contract work,

Similar Jobs

Chipton‑Ross Inc

214226 - Pipe Fitter Job at Chipton‑Ross Inc

 ...Chipton-Ross is seeking a Pipe Fitter for a contract opportunity in Marinette, WI.BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):Ability to follow directions under intermittent supervisionExperience cutting, threading, or bending pipes to specificationsAbility... 

Merck

2026 University Recruiting - IT Emerging Talent Summer Intern Program (Hybrid) Job at Merck

 ...technological organizational capabilities. We collaborate internationally to deliver services and solutions across our organization....  ...date after August 2026. Preferred majors include Technology, Computer Science, Information Systems, Information Technology, Engineering,... 

Wolfgang Puck Catering

Executive Chef Job at Wolfgang Puck Catering

 ...Wolfgang Puck Catering is seeking a dynamic and visionary Executive Chef to lead our culinary operations at The Fillmore Philadelphia and Tower Theater . If youre an upbeat, entrepreneurial culinary leader with a passion for unforgettable dining experiences, this... 

CRH

Quarry Driller Job at CRH

 ...supported the construction of superior roads, buildings and bridges. The most respected name in the construction industry, from the quarry to the road, Tilcon Connecticut does it all! Are you looking for opportunities and benefits of a large corporation with a small... 

Saint John Paul the Great

School Counselor Job at Saint John Paul the Great

Saint John Paul the Great Catholic High School located in Potomac Shores, Virginia is looking for a full time School Counselor for the 2025-2026 school year. Ideal candidates will have counseling experience in a school setting, Secondary/High School experience preferred...