Tufts Medical Center Clinical Research Coordinator II in Boston, Massachusetts
Clinical Research Coordinator II
Schedule: Full-Time Regular
Shift: Day shift
Bachelor's degree is required
1-2 years experience is required
This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.
PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:
Responsible for assisting in the recruitment of study participants. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. Reviews all eligibility and ineligibility criteria in the patient's record. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.
Completes follow up with study participants in prescribed settings as required.
Completes 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.
Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.
Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.
Performs basic laboratory activities as needed.
Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests,etc.
Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
Maintains inventory of all study supplies.
JOB KNOWLEDGE AND SKILLS:
High degree of organizational talents, data collection and analysis skills.
Requires 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
Previous experience in clinical trials desirable
BS or equivalent
2-5 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.
LICENSES, ETC. :
BLS certification may be required based on specific role requirements
IATA Hazardous Good Shipping Certification
CITI Human Research Protection Certification
WORKING CONDITIONS/PHYSICAL DEMANDS:
Typical clinical and administrative office setting.
Must be able to perform all essential functions of this position with reasonable accommodation if disabled.
May access PHI/HIPAA identifiers as part of daily tasks.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.