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

Tufts Medicine; Boston (MA); Hybrid; USD 125,000 - 150,000; Full time

Job summary

An established industry player is seeking a dedicated individual to assist in clinical research studies. This role involves recruiting participants, ensuring compliance with protocols, and maintaining documentation. The ideal candidate will have strong organizational skills, attention to detail, and excellent communication abilities. You'll be part of a dynamic team that values meticulous work and adherence to best practices in clinical research. If you are passionate about contributing to significant medical studies and thrive in a collaborative environment, this opportunity is perfect for you. Join a forward-thinking organization that prioritizes innovation and excellence in healthcare.

Qualifications

• Bachelor's degree or equivalent with 4 years of related experience required.
• BLS certification may be required based on specific role requirements.

Responsibilities

• Assist in recruiting study participants and assess eligibility for protocols.
• Maintain regulatory binders and monitor clinical adverse events.

Skills

Organizational skills

Data collection and analysis

Attention to detail

Computer skills

Communication skills

Interpersonal skills

Record-keeping

Education

Bachelor's degree

High School Diploma or equivalent

Tools

Basic Life Support (BLS)

Job description

Job Summary:

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.

Principal Duties And Essential Functions:

1. 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, explains the study, and obtains signature for the informed consent form.
2. Completes follow up with study participants in prescribed settings as required.
3. Completes record abstraction of source documents, conducts required study measurements, and completes study Case Report Forms in accordance with best practice methods. Conducts a QC check of completed CRFs prior to submission for data entry; coordinates resolution of all data queries. Completes data entry as warranted.
4. 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.
5. Responsible for 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.
6. Performs basic laboratory activities as needed.
7. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
8. Identifies and resolves problems with protocol compliance by notifying the investigator and, as necessary, with the protocol sponsor.
9. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
10. Participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
11. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.

Job Knowledge & Skills:

1. High degree of organizational talents, data collection, and analysis skills.
2. Requires meticulous attention to detail.
3. Excellent computer skills including word processing.
4. Ability to prioritize quickly and appropriately.
5. Excellent communication and interpersonal skills.
6. Systematic record-keeping.

Minimum Qualifications:

1. Bachelor's degree OR High School Diploma or equivalent AND Four (4) years of related experience.
2. Basic Life Support (BLS) certification may be required based on specific role requirements.

Preferred Qualifications:

1. Two (2) years in research related activities.
2. IATA Hazardous Good Shipping certification.
3. CITI Human Research Protection certification.

Working Conditions/Physical Demands:

1. Typical clinical and administrative office setting.
2. Must be able to perform all essential functions of this position with reasonable accommodation if disabled.
3. May access PHI/HIPAA identifiers as part of daily tasks.

Location:

This position may allow a hybrid working schedule following a 90-day orientation/probationary period.