Bilingual Site Supervisor (English and Spanish)

Johnson County Clintrials LLC•Houston, TX

13h•Onsite

About The Position

The Site Supervisor is responsible for assuring the study team is accountable for performing assigned responsibilities in compliance with project plans, federal regulations, GCP and good medical practice. This position collaborates and participates with internal teams and external stakeholders to ensure all studies are adequately and appropriately resourced and delivered efficiently to timeline, budget and quality expectations. This position reports directly to the Site Director.

Requirements

Demonstrated relationship building skills through professional communication, interpersonal, analytical and problem-solving skills
Demonstrated ability to Coordinate complex protocols with overlapping timelines
Microsoft Office Suite proficiency, technologically skilled in various systems
Strong study documentation skills in compliance with ALCOA+ preferred
Close attention to detail and strong organizational skills to deliver high-quality work within project timelines
Demonstrates strong analytical, problem-solving skill
Must be results oriented, multi-tasking and a quick learner
Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferred
Demonstrated risk identification and mitigation
Ability to effectively lead a team
Ability to prioritize and manage multiple projects simultaneously
Previous experience training and mentoring others
Time management skills
Minimum 4 years of experience in clinical research
Strong knowledge of relevant regulations ICH/GCP and FDA guidelines
Effective site management and organizational skills/ability to meet key study milestones
BS/BA in Life Science or related discipline or equivalent work experience
Basic understanding of regulations governing clinical research (CFR, HIPAA)
Previous nursing, medical assistant experience in a clinical setting a plus
CCRC certification a plus
Demonstrated relationship building, with strong verbal and written skills.
Ability to successfully coordinate protocols with overlapping timelines
Ability to travel as needed: to support other sites, attend audits, attend meetings (Investigator Meetings, conferences, etc.)
Ability to explain importance of GCP guidelines and their application
Ability to train others on coordinating responsibilities and protocol adherence
Able to clearly explain and enforce clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting
Strong interpersonal skills with attention to detail a must
Proven ethical and professional codes of conduct
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems.

Nice To Haves

Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferred
Previous nursing, medical assistant experience in a clinical setting a plus
CCRC certification a plus

Responsibilities

Oversees leadership of the Clinical Operations team while ensuring site training/communications are occurring
Actively participates in the coordination of clinical trials
Ensures study compliance against protocol, SOPs, regulations and ICH/GCP guidelines
Acts as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines
Build and maintain strong relationships with investigators, referring physicians, and community partners
Ensures timely responses from clinical site staff and all regulatory agencies
Develop strong, collaborative working relationships with CROs, sponsors, investigators, escalates to Site Director as needed
With input from the Site Director, allocates studies across teams
Oversees that all study Start-Up activities are in place for any new study prior to consenting participants. Oversees ongoing study progress, data collection, and cleaning activities for all study trials under their purview
Prepares reports, drives site to hit KPIs and provides ongoing updates for leadership team/meetings
Provides oversight and mentors CRCs on source quality
Interviews and onboards new hires
Conducts continuing performance management and annual reviews
Works with QA to write, resolve and identify all CAPAs
Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirements
Communicates out of scope activities to ensure billing compliance and communicates all study invoiceables timely
Ensures staff work is “inspection ready” at all times
Represent the site at industry meetings and conferences