The Clinical Research Associate monitors activities at clinical research study sites and assures adherence to study protocols and SOPs.
Essential Duties and Responsibilities:
Coordination and management of clinical trial sites
Monitor via on site visits and via remote review of data collected: if the protocol is adhered to, if the study is performed in compliance with GCP, checks if IRB approvals are still valid and in place.
Review in time the eCRF data collection system on completeness and timely query resolution and closure.
Site management: build and maintain good relations with investigators and site staff.
Ensure that patient enrolment on site follows agreed recruitment plan
Close down study centers on completion of the trial.
Ensure that study staff conducting the protocol has received the proper materials and instructions to enter patients into the study.
Ensure that the rights, well-being, and safety of human subjects are protected by verifying that informed consent procedures and protocol requirements are adhered to according to regulatory requirements.
Ensure data is submitted on Case Report Forms (CRFs) or other data collection tools.
Monitor data for missing or implausible data.
Maintain proper documentation of all site correspondence.
Assist in the training and mentoring of personnel.
Contact and troubleshoots non enrolling sites.
Perform monitoring and performs clinical closeouts in one or more programs.
Performs other related duties as required or assigned
This position may interface with all departments within the company as well as outside vendors and regulatory agencies.
Education and Experience Requirements:
Bachelor’s degree in Life Sciences (e.g., Biology, Nursing, Pharmacology)
1 + years site monitoring experience
2 + years experience working in Oncology (as a monitor, coordinator, or nurse)
In-depth experience with each stage of a clinical trial (i.e. study start-up through archive) and study site management
In-depth experience with each type of site monitoring visit (pre-study, initiation, interim, close-out)
Certificates and License Requirements:
Completion of ICH/GCP course
Skills and Qualifications Requirements:
· Thorough knowledge of FDA GCP-ICH Guidelines and local regulatory requirements
· Customer service orientation
· Sound knowledge of medical terminology and clinical monitoring process
· In depth therapeutic and protocol knowledge as provided in company training
· Excellent verbal and written communications skills
· Excellent interpersonal and organizational skills and attention to detail
· Computer literacy, proficiency in MS Office
· Strong Leadership Skills
· CCRA Certification - Association of Clinical Research Professionals
This position requires no supervisory responsibilities.
General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Maintains a clean, neat, and orderly work area.
Adheres to Department Specific Safety Guidelines.
Experience working remotely/home office
Up to 50%
Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 15 pounds.
Internal Number: CRA 042000-081018
About Agendia, Inc.
Agendia is a leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s tests were developed using an unbiased gene selection by analyzing the complete human genome. This includes MammaPrint as well as BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology, TheraPrint, and TargetPrint, an ER/PR/HER2 expression assay. MammaPrint is the only breast cancer recurrence assay backed by peer-reviewed, prospective outcome data. These tests can help physicians assess a patient’s individual risk for metastasis, which patients may benefit from chemo, hormonal, or combination therapy, and which patients may not require these treatments and can instead be treated with other, less arduous and less costly methods. In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and the MINDACT trials. For ...more information, visit www.agendia.com. Twitter: http://www.twitter.com/Agendia Facebook: http://www.facebook.com/AgendiaInc YouTube: http://www.youtube.com/AgendiaInc