Freelance /Contractual Clinical Research Associate, Dermatology & Rheumatology C
Indero (formerly Innovaderm), New Bremen, OH, United States
Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Indero and sponsor SOPs, ICH/CGP guidelines and applicable regulations.
Participate in investigators’ meetings.
Prepare site visit reports and follow-up letters to the investigator.
Build productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets.
Perform source data verification, ensure on-site study drug storage, dispensing, and accountability; verify data collection, and regulatory document collection is adequate.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Qualifications
Education
B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience.
Experience
3 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
At least 1 year of experience in dermatology.
Knowledge & 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 judgment 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.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Germany.
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Conduct site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Indero and sponsor SOPs, ICH/CGP guidelines and applicable regulations.
Participate in investigators’ meetings.
Prepare site visit reports and follow-up letters to the investigator.
Build productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets.
Perform source data verification, ensure on-site study drug storage, dispensing, and accountability; verify data collection, and regulatory document collection is adequate.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Qualifications
Education
B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience.
Experience
3 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
At least 1 year of experience in dermatology.
Knowledge & 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 judgment 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.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Germany.
#J-18808-Ljbffr