Job Details

• You will support enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements 

• You will be responsible for working with the principal investigator to meet or exceed study enrollment. 

• You will review the study design and inclusion/exclusion criteria with physician and patient 

• You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance 

• You will ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data 

• You will ensure that adequate and accurate records are maintained for inspecting

• You will create study specific tools for source documentation when not provided by sponsor 

• You will collect, complete, and enter data into study specific case report forms or electronic data capture systems as needed 

• You will generate and track drug shipments, device shipments, and supplies as needed 

• You will report and follow up on serious adverse events as necessary 

• You will implement study-specific communications 

• You will ensuretimely adherence to protocol requirements 

• You will be responsible for completion of all required documentation according to site working practice guidelines 

• You will ensuretimely and accurate data completion 

• You will maintainaccurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs and study-related communications 

• You will track and report adverse events, serious adverse events, protocol waivers, deviations, and violations 

• You will communicate all protocol-related issues to appropriate study colleagues or manager 

• You will attend study specific on site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so 

• You will apprise the principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance 

You should have:

• Knowledge of federal regulations, good clinical practices (GCP)

• Knowledge of medical and research terminology

• Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel

• Excellent Verbal and written communication skills

• Excellent interpersonal skills

• The ability to communicate and work effectively with a diverse team of professionals

• Organizational and prioritizing capabilities

• The ability to work independently in a fast pace environment with minimal supervision at off-site facilities

• At least one year of experience as a Clinical Research Coordinator or Study Coordinator