Clinical Research Administrative Assistant – PRN/Part-Time

Clinical Research Administrative Assistant – PRN/Part-Time

Position Summary

The Clinical Research Administrative Assistant provides flexible administrative, regulatory, operational, and patient-support assistance to the Clinical Research Department. This position is intended to provide additional support during periods of increased workload and to assist with maintaining timely, organized, and accurate research operations.

The ideal candidate is highly organized, dependable, detail-oriented, comfortable working with electronic systems and documentation, and able to move between administrative, research, and patient-support responsibilities as needed.

This position works under the direction and supervision of the Director of Research and other designated members of the research team. Responsibilities will vary based on departmental needs, study requirements, training, and delegated duties.

Essential Duties and Responsibilities

Research & Regulatory Support

- Maintain organized paper and electronic research files and documentation.

- Scan, upload, name, index, and file documents according to departmental procedures.

- Assist with maintaining electronic Investigator Site Files (eISF) and other research documentation systems.

- Assist with document management in
Veeva SiteVault or similar electronic document/eISF platforms.

- Distribute study documents, training materials, and other required materials to appropriate research staff.

- Track and assist with completion of required training documentation.

- Assist with preparing documents requested by study monitors, Clinical Research Associates (CRAs), sponsors, and other research personnel.

- Locate, retrieve, scan, and transmit requested study documentation under the direction of research leadership.

- Assist with preparation for monitoring visits, audits, and other research-related activities.

- Maintain organized regulatory and administrative records and assist with quality-control activities.

- Follow applicable research procedures, sponsor requirements, Good Clinical Practice (GCP), HIPAA, and departmental policies.

Research Data & Study Support

- Perform accurate data entry from patient visits and research source documentation.

- Enter study-related information into sponsor electronic data capture (EDC) and other electronic research systems as trained and authorized.

- Assist research staff with data entry, data review, and documentation follow-up.

- Assist with entering completed visit information and procedures into internal systems used to prepare sponsor invoices.

- Accurately document visit activities, procedures, and other billable study-related information for review by the Director of Finance.

- Assist with tracking study-related administrative tasks, supplies, documents, and deadlines.

- Provide general administrative support to Clinical Research Coordinators, Research Nurses, and research leadership.

Electronic Health Record & Office Systems

- Utilize
eClinicalWorks (eCW) and other electronic health record or practice-management systems as trained and authorized.

- Assist with locating and processing appropriate patient or research documentation.

- Perform data entry and administrative tasks across multiple electronic systems.

- Maintain accurate electronic records while protecting confidential and protected health information.

Research Department Communications

- Monitor and assist with management of the general research department email inbox.

- Monitor and process incoming research-related faxes.

- Route emails, faxes, documents, and requests to the appropriate team member.

- Assist with responding to routine questions within the employee's training and scope of responsibility.

- Communicate professionally with patients, research participants, sponsors, monitors, vendors, and internal staff.

- Assist with scheduling research-related appointments and communicating appointment information to patients.

- Contact patients by telephone or other approved communication methods regarding appointments, forms, documents, and routine study-related administrative matters.

- Send patients documents for review or completion and assist with processing returned forms.

Patient & Clinical Support

When appropriately trained and delegated, the employee may:

- Greet and assist research participants and patients.

- Escort or bring patients to appropriate examination or research rooms.

- Assist research staff with preparing rooms and supplies for patient visits.

- Retrieve supplies, equipment, records, or other materials needed during patient visits.

- Assist with obtaining and documenting routine vital signs or other basic clinical information when appropriately trained and authorized.

- Assist with other non-clinical patient-support activities as directed by research leadership.

Clinical activities will only be performed when the employee has received appropriate training and has been authorized and/or delegated to perform the activity.

General Office & Facility Support

- Maintain organized administrative, research, storage, and shared work areas.

- Assist with scanning, copying, printing, filing, shredding, and document preparation.

- Receive, unpack, organize, and put away office, research, and clinical supplies.

- Assist with inventory organization and supply storage.

- Deliver documents, supplies, and other items to appropriate departments or areas of the facility.

- Assist with maintaining clean and orderly breakrooms, examination rooms, administrative areas, storage areas, and other designated spaces.

- Assist with basic room setup and cleanup as needed.

- Provide general administrative and operational assistance wherever needed to support the efficient operation of the Clinical Research Department.

Required Qualifications

- High school diploma or equivalent.

- Strong organizational and time-management skills.

- Excellent attention to detail and accuracy.

- Ability to maintain confidentiality and handle sensitive information appropriately.

- Ability to follow written procedures and instructions.

- Ability to work independently while recognizing when questions or escalation are necessary.

- Strong written and verbal communication skills.

- Comfortable working with computers, electronic records, email, scanning, document management, and multiple software systems.

- Ability to prioritize and manage multiple tasks in a busy clinical research environment.

- Professional and courteous demeanor when interacting with patients, coworkers, sponsors, monitors, and other visitors.

Preferred Qualifications

- Previous experience in a medical office, clinical research, healthcare, or administrative environment.

- Experience with
eClinicalWorks (eCW) or another electronic health record system.

- Experience with
Veeva SiteVault , an electronic Investigator Site File (eISF), or similar document-management system.

- Experience with electronic data capture (EDC) or sponsor clinical trial systems.

- Previous clinical research or clinical trial experience.

- Familiarity with Good Clinical Practice (GCP), research documentation, or regulatory requirements.

- Experience working with sponsors, CROs, Clinical Research Associates (CRAs), or clinical research teams.

- Experience with document control, quality assurance, or regulatory filing.

Required Training & Certifications

The following training and certifications are required for this position. Employees who do not already hold these certifications will be provided the opportunity to complete the required training through the Clinical Research Department during onboarding.
Employees are not responsible for the cost of required training provided by the department.

- Good Clinical Practice (GCP) Certification — Required.

- Human Subject Protection (HSP) / Human Research Protection (HRP) Certification — Required. This training may be referred to by different names depending on the training provider.

- IATA/Dangerous Goods Training for the Transport of Biological Substances — Required for applicable research activities involving the preparation or handling of research shipments.

Previous completion of any of the above certifications is  preferred and considered a plus , but is not required prior to employment.

Skills & Competencies

- Attention to Detail: Consistently produces accurate work and recognizes discrepancies or missing information.

- Organization: Keeps documents, information, supplies, and tasks organized and accessible.

- Confidentiality: Understands the importance of protecting patient, research, and business information.

- Adaptability: Comfortable moving between administrative, research, patient-support, and operational tasks.

- Technology: Able to learn and navigate multiple electronic systems.

Experience with the following is preferred:

Microsoft Outlook (email, calendars, and shared mailboxes)

- Microsoft Teams (messaging, meetings, file sharing, and collaboration)

- Microsoft Word (document creation and formatting)

- Microsoft Excel (data entry, spreadsheets, sorting/filering, and basic data organization)

- Adobe Acrobat / Adobe PDF tools (scanning, combining, organizing, editing, and prearing PDF documents)

- Electronic Health Record (EHR) systems (particularly eClinicalWorks - eCW)

- Electronic Investigator Site Files - eISF (particularly Veeva SiteVault)

- Electronic Data Capture (EDC) and other sponsor-provided clinical research systems.

- Communication: Communicates clearly and professionally with patients, coworkers, research sponsors, monitors, and other stakeholders.

- Teamwork: Willingly assists team members and contributes to the overall operation of the department.

- Reliability: Follows through on assigned responsibilities and communicates when additional assistance or clarification is needed.

- Initiative: Recognizes routine tasks that need attention and takes appropriate action within their scope.

Schedule & Availability

This is a  PRN / Part-time position averaging approximately 20 hours per week , generally scheduled in four-hour shifts (or more) during the Clinical Research Department's normal operating hours of Monday through Friday, 8:00 AM–5:00 PM .

Because this position is designed to provide flexible support to a busy clinical research site, the number and timing of hours may vary from week to week. Some weeks may require fewer than 20 hours based on patient volume and departmental workload, while busier weeks may require additional hours, potentially up to approximately 30 hours.

Scheduling will be based on the operational needs of the research site, including patient volume, study activity, monitoring activity, regulatory workload, and other departmental priorities. Flexibility and willingness to adjust the schedule when needed are important aspects of this position.

Whenever possible, the department will provide advance notice of scheduling needs.

Work Environment

This position works in a clinical research and medical office environment and may involve frequent interaction with patients, research participants, healthcare professionals, research staff, sponsors, monitors, and other visitors.

The position may require extended periods of computer and desk work as well as periods of standing, walking, filing, scanning, organizing supplies, preparing rooms, and assisting with general departmental operations.

Important Scope of Role

This position is a support role and does not independently assume responsibility for clinical research studies, regulatory oversight, medical decision-making, or study-specific responsibilities requiring professional licensure or formal delegation. Duties and responsibilities may change based on departmental needs, study requirements, employee training, and appropriate delegation.