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Clinical Study Team Assistant I

Company: Pfizer
Location: Groton
Posted on: June 11, 2021

Job Description:

Partners with the Clinical Study Team Lead to provide study level operational and logistical support to clinical study teams to ensure the timely and efficient execution of clinical trials and compliance with ICG-GCP, SOP, and regulatory requirements.

Works proactively and independently to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes.

Collaborates with global cross functional study team members of varying levels of seniority.

Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards.

Has fundamental knowledge of the principles and concepts related to the CSTA role.

Provide study level operational support from study start up to close out and submission.

As a core study team member, the CSTA is responsible for providing operational support at the study level for assigned including but not limited to:

  • Set up and maintenance of Study Team shared spaces
  • TMF maintenance, compliance, and oversight
  • Study Team on Demand (STOD) set up and maintenance
  • Corporate Clinical Trial Registry (CCTR) compliance and maintenance
  • Tracking of study level information
  • Update and/or run study level reports from various clinical trial operational systems
  • QC of essential study level documentation from study start up through CSR and submissions
  • Assist with completion of various study level forms and study level data entry into various clinical trial management systems
  • Administrative tasks related to Independent Oversight Committees
  • Inspection readiness
  • Clinical Trial Budget invoicing and tracking
  • Study Team Meeting (CSTL Led)
  • Investigator Meetings

Provide status updates on key tasks and activities to the CSTL and contributes to the Core Study Team Meetings.

Independently manage conflicting priorities to ensure excellent support to assigned study teams. Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables).

Collaborates with cross functional study team members to ensure completion of assigned tasks.

BASIC QUALIFICATIONS:

  • 1-3 years of experience managing or coordinating projects.
  • Associates or Bachelor's Degree, Masters degree will be a plus.
  • Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)
  • Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research

PREFERRED QUALIFICATIONS

  • Science background
  • Experienced with clinical trial applications
  • Effective verbal and written communication skills
  • Ability to work independently but also as part of a larger team with limited support from supervisor
  • Ability to multitask and manage multiple competing priorities
  • Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality
  • Knowledge of drug development process
  • Administrative excellence: Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
  • Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team to identify and resolve complex problems; Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems

PHYSICAL/MENTAL REQUIREMENTS

N/A

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel for group meetings (approximately 1-2 times per year).

Last Date to Apply for Job: June 8th, 2021

Eligible for Relocation Package: NO

Eligible for Employee Referral Bonus: YES

#LI-PFE

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Medical

Keywords: Pfizer, Newton , Clinical Study Team Assistant I, Other , Groton, Massachusetts

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