Senior Clinical Research Associate, Dermatology & Rheumatology CRO, USA

Indero•Boston, MA

26d

About The Position

Senior Clinical Research Associate, Dermatology & Rheumatology (Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin. The senior clinical research associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. This role will be perfect for you if : You are a seasoned Clinical Research Associate (CRA) who thrives in autonomous environments and consistently meets high-quality standards and deadlines. You bring experience in dermatology and rheumatology, and you're eager to deepen your expertise in these therapeutic areas. You value working within a mid-sized CRO where your contributions are visible, appreciated, and have a direct impact.

Requirements

B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
At least 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
Rheumatology exposure
Good knowledge of ICH/GCP standards and applicable regulatory requirements
Strong verbal and written communication skills in English
Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
Excellent judgement and problem-solving skills
Travel to research sites approximately 65% of the time
Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)

Nice To Haves

Experience in dermatology is an asset

Responsibilities

Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations
Participates in investigators’ meetings
Prepares site visit reports and follow-up letters to the investigator
Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets
Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate
Reviews and approves site visit reports.
Tracks site visit and trip report metrics and escalates issues to project teams.
Recommends potential solutions to identified issues and work with the project managers to find resolution.
Supports the development of annotated site visit reports, clinical monitoring plans, and monitoring tools.
Supports the preparation and development of materials related to the training of CRAs.
Mentors CRAs.
Conducts on-site quality control visits with CRAs.