Clinical Research Coordinator - Res G&C - Neely Center for Clinical Cancer Research

Tufts Medicine•Boston, MA

2d•$44,779 - $55,978•Onsite

About The Position

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. The role involves assisting in the recruitment of study participants, assessing patient eligibility, explaining studies, and obtaining informed consent. It also includes completing follow-up with study participants, performing record abstraction, conducting QC checks of Case Report Forms (CRFs), and entering data. The coordinator must comply with all institutional policies and government regulations regarding human subjects protection, maintain regulatory binders, monitor adverse events, and assist with Institutional Review Board (IRB) requirements. Additionally, the role may involve performing basic laboratory activities, maintaining patient confidentiality, adhering to FDA Good Clinical Practice Guidelines, resolving protocol compliance issues, arranging necessary tests, participating in sponsor site visits, performing tests like EKGs and Walk tests, and maintaining study supply inventory.

Requirements

BS or equivalent
0-2 years experience in research related activities
An equivalent combination of education and experience which provides proficiency in the areas of responsibility listed above may be substituted for the above education and experience requirements.
High degree of organizational talents, data collection and analysis skills.
Meticulous attention to detail.
Excellent computer skills including word processing.
Ability to prioritize quickly and appropriately.
Excellent communication and interpersonal skills.
Care in organization and systematic record-keeping.

Nice To Haves

BLS certification may be required based on specific role requirements
IATA Hazardous Good Shipping Certification
CITI Human Research Protection Certification

Responsibilities

Assisting in the recruitment of study participants.
Assessing potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.
Reviewing all eligibility and ineligibility criteria in the patient’s record.
Verifying information with the physician.
Interviewing patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
Completing follow up with study participants in prescribed settings as required.
Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.
Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries.
Completing data entry as warranted.
Complying with all institutional policies and government regulations pertaining to human subjects protections.
Maintaining regulatory binders, case report forms, source documents, and other study documents.
Monitoring the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.
Assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews.
Performing basic laboratory activities as needed.
Maintaining patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location.
Adhering to FDA Good Clinical Practice Guidelines.
Identifying and resolving problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
Arranging necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
Participating in site visits with the study sponsor to review completeness and accuracy of study documentation.
Performing necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests,etc.
Maintaining inventory of all study supplies.