Full Job Description
DOCS is searching for a Site Manager II (CRA II) for the Early Development group for a major sponsor. Sites are located in New York City area but will consider all candidates in Northeast with Phase I monitoring experience.
A Site Manager is the person in Early Development & Clinical Pharmacology (ED&CP) that serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site/lab assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training
Minimum of 2 years of previous Early Development field monitoring experience for a Pharmaceutical or CRO
Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Good IT skills in appropriate software and company systems.
Willingness to travel with occasional/regular overnight stay away from home depending on the region.
Proficient in speaking and writing the country language and English. Good written and oral communication skills.
Flexible mindset and ability to work at a fast pace within small exploratory study teams with accelerated cycle times
Ability to work on multiple trials in parallel in different disease areas (Solid Tumor and Hematology)
4-year University degree in Life Sciences, Nursing, or related scientific field is preferred.
Experience in monitoring ED&CP studies is required.
A minimum of 2 year of clinical trial monitoring experience is required, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.