Clinical Research Administrative Assistant – PRN/Part-Time

Gordon Crofoot MD, PA•Houston, TX

3d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.
Good Clinical Practice (GCP) Certification
Human Subject Protection (HSP) / Human Research Protection (HRP) Certification
IATA/Dangerous Goods Training for the Transport of Biological Substances
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)

Responsibilities

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.
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.
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.
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.
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.
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.