JOB DESCRIPTION

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, explain 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, 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.

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 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.

12. Maintains inventory of all study supplies.

QUALIFICATIONS

Job Knowledge And 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. Care in organization and systematic record-keeping

Education:

BS or equivalent

Experience:

1. 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.

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:

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

At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.

The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.

Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth—one of the many ways we invest in you so you can thrive both at work and outside of it.

Pay Range: