Site Manager (Clinical Research Associate)

1-3 years

Not Disclosed

Remote, USA

10 Aug. 21, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Site Manager, Early Development
Location: UK (Home-Based, with Head Office in High Wycombe, Buckinghamshire)

Company: Janssen (Johnson & Johnson Family of Companies)

About the Role:
We are seeking a Site Manager in Early Development (ED) to act as the primary contact between the sponsor and investigational sites (commercial and hospital) for early development and clinical pharmacology studies. The role involves ensuring inspection readiness through compliance with clinical research protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOP), and applicable regulations. This position is home-based, with the head office located in High Wycombe, Buckinghamshire.

Key Responsibilities:

Conduct site assessments, pre-trial visits, and site selection in collaboration with the trial team.
Serve as the primary contact for assigned sites, working closely with the Trial Manager and central team to monitor study progress and resolve issues.
Participate in investigator meetings as required.
Execute site initiation, start-up, monitoring, management, and close-out activities in line with internal SOPs and policies.
Ensure site staff are trained in GCP, protocol, compound, and systems, and maintain proper training records.
Contribute to site-level recruitment strategies and contingency planning to achieve clinical research targets.
Manage site study supplies and ensure investigational product handling, administration, storage, and documentation adhere to guidelines.
Document trial-related activities thoroughly in all study files and communicate site and study progress to the Local Trials Manager and central study teams.
Track and manage site-level costs and payments, collaborating with relevant departments.
Build and maintain strong relationships with investigators, trial coordinators, and other stakeholders.
Participate in process improvement and training initiatives as needed.

Qualifications:

BA/BS degree in Life Sciences, Nursing, or a related field (or equivalent experience).
Minimum of 1 year of clinical trial monitoring experience preferred; other relevant experience may be considered.
Minimum of 1.5 years of experience in Phase 1 trials preferred, with a focus on Haematology.
Strong knowledge of GCP, local laws, and regulations.
Familiarity with systems such as mCTMS, vTMF, and Medidata Rave is preferred.
Willingness to travel with occasional overnight stays.
Proficiency in local languages and English, with strong written and oral communication skills.
Full UK driving license.

Benefits: We offer a competitive salary and a comprehensive benefits package. We prioritize the health and well-being of our employees, providing a flexible working environment to promote work-life balance. Career development opportunities are available for those seeking growth within our organization.

Equal Opportunity:
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, protected veteran status, or disability.

We are committed to providing reasonable accommodations for individuals with disabilities during the application or interview process and in the performance of job functions. Please contact us to request accommodation.

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Site Manager (Clinical Research Associate)

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