Research Associate Clinical I Jobs in New Jersey

Clinical Trial Collaboration: Work alongside our clinical team, focusing on site qualification, initiation, management, and data integrity.

Data Management: Oversee data activities, generate, and resolve queries, and report on study metrics including enrollment and adverse events documentation.

Regulatory Oversight: Manage investigational product accountability, monitor IRB requirements, and ensure prompt processing of regulatory documents.

Bachelor’s degree in a medical/scientific field, with 4+ years of clinical research experience (Master’s degree can substitute for 1 year).

Strong organizational, multitasking, and relationship-building abilities.

Effective communication skills and keen attention to detail.

Assist with site audits and site quality management activities, as needed.

Ensure monitoring activities (remote and on-site) are completed in accordance with Agilent procedures and study monitoring plan.

Assures adherence to GCP, study protocol, and all applicable requirements through routine monitoring visits.

3+ years direct clinical research experience at a sponsor or CRO as a CRA/study monitor, or equivalent experience.

Diagnostic/IVD experience highly preferred, oncology or other medical device experience is also accepted.

Previous experience with NGS, IHC, or pathology highly preferred.

Assist with essential documents collection, review and archiving (TMF management)

Provide project management support for PTX project team, including vendor oversight

Conduct Site Initiation, Routine, and Close-out monitoring site visits, either on-site or remotely, prepare visit correspondence and records including trip reports

Phases I-IV ONCOLOGY Trial experience

Oversee the conduct of assigned study sites, including ensuring compliance with SOPs, federal and local regulations, and ICH and GCP guidelines

Assist in the review and /or development of clinical trial documents such as study plans and training materials

• Ability to effectively interact with and support all levels of management

• Conduct site qualification, monitoring, close-out, and monitoring oversight visits

• Good Clinical Practice (GCP) and ICH certification preferred

• Knowledge of the pharmaceutical industry and the drug development process

• At least 2 years on-site monitoring experience in Clinical R&D

• Knowledge of clinical research policies and procedures

Edison, New Jersey 08817 or Remote or Hybrid

highly qualified, experienced, and passionate professionals, dedicated to providing unparalleled customer service

·Experience hosting/performing internal and external audits is preferred

·Oncology, Ophthalmology and Metabolic Diseases experience

·Minimum 3 years of experience as an independent CRA

8 Hours/day or more as needed

Previous experience that provides the knowledge, skills, and abilities to perform the job

The CRA will complete all role specific required training and documents needed in the applicable learning management system

Previous independent monitoring experience is essential

They will comply all applicable Bionical Emas SOPs and policies

Completes and submits timesheet and expenses in a timely manner, as per company guidelines

When necessary, they will be a mentor to other CRAs