Associate Site Manager – Oncology

Location

District Of Columbia + 6 moreAll locations: District Of Columbia | Florida | North Carolina | Maryland | South Carolina | Virginia | West Virginia

Posted

3 days ago

Salary

$76K - $121.9K / year

Seniority

Mid Level

Bachelor Degree1 yr expEnglish

Job Description

Associate Site Manager – Oncology

Johnson & Johnson

• Act as primary local company contact for assigned sites for specific trials. • Actively participate in site feasibility and/or Site Qualification Visits (SQVs). • Attend/participate in investigator meetings as needed. • Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. • Implementation of analytical risk-based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits. • Ensure site staff are trained, and the corresponding training records are complete and accurate at any point during all trial phases. • Collaborate closely with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe. • Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. • Ensure site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct. • Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.

Job Requirements

  • A minimum of 1 year of clinical trial monitoring experience is required.
  • A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific Discipline is required.
  • Experience in the Oncology therapeutic area is preferred.
  • Experience with Phase II and Phase III Clinical Trials is preferred.
  • Basic working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures, including monitoring guidelines, is required.
  • Strong computer skills in appropriate software applications and related clinical systems required.
  • Must have strong written and oral communication skills.
  • Willingness to travel up to 60% with overnight stay away from home is required.
  • A valid Driver's License issued in one of the 50 United States and a good driving record is required.

Benefits

  • Vacation - 120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 hours per calendar year
  • Holiday pay, including Floating Holidays - 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
  • Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
  • Caregiver Leave - 10 days
  • Volunteer Leave - 4 days
  • Military Spouse Time-Off - 80 hours

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