Job Purpose:
Responsible for initiating, coordinating, and operating clinical studies under the supervision of, and in collaboration with, the Clinical Research Manager. Performs duties related to implementing clinical trials and research projects. Ensures adherence to appropriate protocols in the recruitment, screening, enrollment, treatment, follow-up, discharge, and retention of study patients in accordance with Good Clinical Practice (GCP) and ICH Guidelines. Have working knowledge of all study protocols and availability to serve as a backup coordinator and/or rater for other studies as needed. Collects, organizes, and maintains patient data and regulatory files as required.
Essential Job Functions including, but not limited to:
- Key point of contact for obtaining and initiating new clinical studies, with associated duties including but not limited to completion of feasibility questionnaires, preparation of regulatory documents and submissions to regulatory authorities for initial approval, corresponding with study Sponsors and CROs to schedule Pre-Site Selection (PSV) and Site Initiation Visits (SIV), and other study start-up processes as applicable
- Assist with onboarding procedures for new site staff
- Conducting and appropriately documenting informed consent procedures
- Collecting accurate and verifiable data to ensure completion of study-specific data and case report forms
- Maintain subject binders, investigator site file (ISF) and investigational medicinal product (IMP) binders
- Dispense, administer, and/or prepare IMP as required per protocol. Maintain accurate and organized master and subject-level IMP accountability logs. Ensure proper IMP storage and destruction procedures are followed according to site SOP and study protocols
- Collecting, shipping, and handling laboratory specimens as required
- Safeguarding GCP and protocol compliance
- Communicating with study Sponsors and study monitors to ensure appropriate subject data management and conduction of protocols
- Facilitate and organize key research meetings with site staff, including but not limited to weekly meetings with Principal Investigator (PI), site staff trainings, etc.
- Assisting with various clinical tasks such as questionnaire or cognitive test administration, vital signs collection, ECG administration, etc.
- Scheduling subject initial and follow-up appointments, monitoring visits, and other essential appointments as needed
- Coordinating and conducting study close-out procedures
- Offsite duties: limited travel to investigator meetings and other sponsor-related events; travel to pick up dry ice
- Interest in manuscript writing/editing to prepare for submission to research journals and scientific meetings (as applicable) is preferred, but not required
- Working as a team player with colleagues in all departments within NCNE
- Abiding by all OSHA and HIPAA compliance requirements and perform responsibilities in an ethical manner consistent with NCNE values, policies, and procedures
Required Education:
- 3-5+ years clinical research experience or related clinical research positions or equivalent experience preferred
- BS / BA in social or biological sciences; prior experience in clinical research environment; or an equivalent combination of education and experience in a health-related field
Skill, Licensure and Knowledge Requirements:
- Scientific/medical field with demonstrated proficiency in medical terminology
- Regulatory/FDA codes and guidelines for Good Clinical Practices
- Administration of medication
- Medical equipment and instruments to administer patient care
- FDA audits
- OSHA compliance
- HIPAA compliance
- NCNE facility and emergency plans
- NCNE policies and procedures
Physical Demands:
The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach.
- Specific vision abilities required by this job include close vision requirements due to computer work.
- Light to moderate lifting is required.
Work Environment:
The work environment characteristics described here are representative of those the employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Moderate noise (i.e., business office with computers, phone, and printers, light traffic).
- Ability to work in a confined area.
- Ability to sit at a computer terminal for an extended period.
EEO Statement
Neurology Center of New England P.C. is an Equal Opportunity employer and does not discriminate in employment on the basis of race, color, religious creed, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, and/or other status protected under law.
