Study Administrator

Position Title:
Study Administrator

Department:
Research Operations

Reports To:
Assistant Operations Manager, Operations Manager

Direct Reports:
N/A

POSITION FUNCTION

The Study Administrator (SA) performs a variety of administrative and clinical activities to assist the research team in the conduct of clinical studies. The SA will have an understanding of study protocols and will assist to coordinate and manage study activities completely and accurately.

ORGANIZATION SUMMARY

Our Passionate Cause:
Revolutionizing Research & Changing Lives

Organization Profile:
IACT Health, LMC Manna Research, and True North Clinical Research joined forces in late 2021 to become Centricity Research. Centricity Research is a clinical research organization with more than 40 sites, access to over 1.6 million patients, and more than 150 active investigators across Canada and the southeastern United States. Our name, Centricity Research, was purposefully chosen to signify the fact that we are customer centric. Our patient volunteers, sponsors, CROs, and physicians are the cornerstone of our business. The name Centricity Research also highlights the fact that our organization has earned a position of prominence and importance within the industry. We aim to build and nurture strong, trusting relationships with all audiences, and being customer-centric is embedded within our company culture.

FUNdamentals:
Centricity Research recognizes the following core values as being essential characteristics for individual and collective success:

- Dream Big
- Go Above and Beyond
- Do The Right Thing
- Be Curious
- Have Fun

ESSENTIAL FUNCTIONS

General
- Gain familiarity of protocols, GCP, and Centricity Research SOPs/WPs and processes
- Assist in chart screening, database query reviews, and recruitment outreach efforts as needed
- Assess overall filing, documentation, reporting, and archiving processes on an on-going basis to identify improvement opportunities and to assist in implementing process improvements
- Archive clinical research documents, track, and maintain all archived documents upon completion of a study
- Assist with on-site quality control
- Attend regularly scheduled site meetings, sponsor training or other meetings as required by the study
- Manage front desk supervision at sites that require this support and serve as backup to Administrative Assistant (in sites with this position)
- Support ordering and coordinating office and medical supplies as needed
- Perform other administrative and clerical duties as required by CRPs and Research Management

Study specific
- Create, maintain, update and organize the Investigator Site File, ensuring compliance to GCP and Centricity SOPs/WPs and processes
- Download and distribute files from portals (e.g., ethics, study specific, etc.)
- Create and maintain the logs and documentation required per study
- Document receipt, maintain inventory, organization, and documentation of Investigational Product and other study supplies
- Prepare research and participant source and study templates, as required
- Perform QC for completeness prior to data entry
- Perform accurate, complete, and timely data entry of CRFs and query resolution
- Support CRPs in addressing monitor findings, and follow-up
- Provide technical support and/or training to study participants where required
- Perform specified tasks of Lab Specialist (based on qualification and designation), if required by the site
- Perform role of un-blinded research staff (e.g. Investigational Product dispensation and/or QC) if required by site and protocol

EDUCATION/EXPERIENCE

Minimum:

- Canada: Either a Bachelor of Science Degree or equivalent OR a healthcare / clinical research diploma (or equivalent experience in a healthcare / clinical research setting (dependent on-site requirements for the role)
- US: HS/GED/ Certified Medical Assistant or other medical training

Preferred:

- Clinical Research Certificate is preferred

CORE COMPETENCIES/SKILLS

Prerequisite (Essential):

- Excellent communication skills (verbal and written)
- Excellent computer skills (MS Word, Excel and Outlook)
- Attention to detail
- Ability to manage time efficiently
- Self-directed
- Teamwork & Collaboration
- Proficient level of clinical, interpretive and analytical skills with organizational skills for project planning
- Flexible & Adaptable
- Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines

Foundation:

- Conflict resolution
- Receptive to feedback
- Empowering & Developing others
- Empathy Skills
- Planning and organizing skills
- Excellent problem-solving skills
- Achievement oriented
- Analytical ability
- Initiative
- Decision making

Leadership:

- Forward thinking
- Innovative
- Creative
- Strategic thinking
- Self confidence
- Strong interpersonal skills

PHYSICAL DEMANDS
- Physical demands include but are not limited to prolonged sitting, light lifting, standing, reaching, walking, and bending.
- Frequently required to complete w