Associate Site Manager, Southeast Region

Johnson & Johnson; Raritan (NJ); Remote; USD 74,000 - 120,000; Full time

Job summary

An established industry player is seeking an Associate Site Manager to oversee clinical trials in the Southeast region. This exciting role involves acting as the primary liaison between the sponsor and trial sites, ensuring compliance with protocols and regulations. You will be responsible for site initiation, monitoring, and close-out activities, collaborating closely with local trial teams to enhance site management. If you are passionate about clinical research and thrive in a dynamic environment, this opportunity offers a chance to make a significant impact in the field while working remotely from anywhere in the United States.

Qualifications

• Minimum 1 year of clinical trial monitoring experience required.
• Basic knowledge of GCP and company SOPs necessary.

Responsibilities

• Act as primary contact for assigned trial sites and ensure compliance.
• Perform site monitoring and manage trial-related activities.

Skills

Clinical Trial Monitoring

Good Clinical Practice (GCP)

Communication Skills

IT Skills

Problem-Solving

Education

BA or BS in Pharmacy, Nursing, or Life Sciences

Tools

Clinical Trial Management Systems

Job description

Job Description - Associate Site Manager, Southeast Region (2406226755W)

Associate Site Manager, Southeast Region - 2406226755W

Description

Johnson & Johnson is currently seeking an Associate Site Manager to cover the southeast region (Washington, DC to Florida). This position can be located remotely in the United States.

This role serves as the primary contact point between the Sponsor and the Investigational Site. An Associate Site Manager is 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 from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Associate Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and TDL (Trial Delivery Leader) to ensure overall site management while performing trial-related activities for assigned protocols.

Key Responsibilities:

• Acts as primary local company contact for assigned sites for specific trials.
• May participate in site feasibility and/or Site Qualification Visit.
• Attends/participates in investigator meetings as needed.
• Responsible for executing 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.
• Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
• Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented.
• Ensures site staff complete data entry and resolve queries within expected timelines.
• Ensures accuracy, validity and completeness of data collected at trial sites.
• Ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
• Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
• Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs.
• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
• Active participation in regularly scheduled team meetings and trainings. Provide feedback as appropriate.
• Complies with relevant training requirements. Act as local expert in assigned protocols.
• Develops therapeutic knowledge sufficient to support role and responsibilities.
• Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring.
• Prepares trial sites for close out, conduct final close out visit.
• Tracks costs at site level and ensure payments are made, if applicable.
• Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
• Acts as a point of contact in site management practices. May contribute to process improvement and training.

Qualifications:

Education:

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience) is required.

Experience and Skills:

Required:

• A minimum of 1 year of clinical trial monitoring experience is required. 1-2 years of clinical trial monitoring experience is preferred.
• Basic working knowledge of GCP, company SOPs, local laws, and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel with occasional overnight stay away from home.
• Proficient in speaking and writing the country language and English. Good written and oral communication.

The anticipated base pay range for this position is $74,000 to $119,600.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.