Associate Site Manager – Cross Therapeutic Area
Location
California + 1 moreAll locations: California | New Jersey
Posted
3 days ago
Salary
$76K - $121.9K / year
Seniority
Mid Level
Job Description
Associate Site Manager – Cross Therapeutic Area
Johnson & Johnson
• Serve as the primary contact point between the Sponsor and the Investigational Site. • Assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines. • Assist with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. • Partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) for overall site management while performing trial related activities. • Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management 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. • Ensure site study supplies are adequate for trial conduct. • Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. • Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
Job Requirements
- A minimum of a bachelor’s degree in pharmacy, Nursing, Life Sciences, or related scientific Discipline is required.
- A minimum of 1 year of clinical trial monitoring experience is required.
- 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
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- long-term incentive program
- 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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