Clinical Research Coordinator III

Tufts Medical Center Boston, MA
* GENERAL SUMMARY:

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. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests,etc.

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.

Performs basic laboratory activities as needed

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.

Reviews protocol with the clinical team and ensure clinical team is aware of their roles and responsibilities.

Maintains communication with IRB and study sponsor and takes lead in reporting adverse events, protocol deviations, safety reports, and other items as directed by regulatory guidelines.

Develops standard operating procedures in collaboration with site staff and sponsor to ensure compliance. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.

May disburse drugs and provide patient teaching regarding administration.

Responsible for assisting with IRB requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.

Initiates, participates, and/or consults in interdisciplinary meetings to formulate, evaluate, and implement appropriate study plans. Monitors enrollment and provide enrollment updates for the clinical team and the sponsors. Collaborates with professional staff both within and outside the hospital.

Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.

Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.

May develop, in collaboration with the investigators and site staff, the site-specific protocol documents and informed consent document, with assistance from the sponsors.

May assist in budgeting clinical trials, grant preparation, and writing research reports and scientific papers.

May be responsible for junior staff supervision.

JOB REQUIREMENTS:

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

Previous experience leading clinical trials

Strong leadership and communication skills.

Previous experience with IRB submissions.

Familiarity of ICH and GCP guidelines.

Supervisory experience desirable

EDUCATION:

MS or equivalent experience

EXPERIENCE:

Minimum five years clinical trial research experience, clinical or scientific related discipline.

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. :

CRA certification desired

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.

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