SENIOR CLINICAL RESEARCH ASSOCIATE, DERMATOLOGY & RHEUMATOLOGY (GERMANY)

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 an experienced CRA with a demonstrated ability to work autonomously to meet quality standards and deadlines
• Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you
• You enjoy working for a mid-sized CRO where your contributions are noticed and valued

EDUCATION

• B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience

EXPERIENCE

• At least 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry

KNOWLEDGE AND SKILLS

• 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)
• Experience in dermatology is an asset
  Our company:

RESPONSIBILITIES

The senior clinical research associate (CRA):

• 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

The Sr CRA may also assume the following Lead CRA responsibilities:

• 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.

Requirements:

This role will be perfect for you if:

• You are an experienced CRA with a demonstrated ability to work autonomously to meet quality standards and deadlines
• Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you
• You enjoy working for a mid-sized CRO where your contributions are noticed and value