Clinical Trial Associate

Headquartered in San Antonio, Texas, Summit Clinical Research is an Integrated Research Organization dedicated to Non-Alcoholic Steatohepatitis (NASH) clinical trials, that delivers a full spectrum of study enrollment and site enrichment services to sites and sponsors in our network. From our inception in 2018, Summit has increasingly built a leadership team of uniquely specialized physicians, and clinical operations team professionals that span the health care industry.

At Summit, we strive to be on the forefront of innovative research by continuing to educate and expand our knowledge in the ever-changing landscape of Liver Disease treatment. As a network, we build upon each other’s successes to empower and inspire one another to achieve greater heights. Summit Clinical Research is committed to company culture, employee retention, and superior therapeutic areas of focus.

Job Title: Clinical Trial Associate

Reports To: Sr. Project Manager

FLSA Status: Non Exempt

Overall responsibility

The Clinical Trial Associate assists the Summit Project Management team with operational planning, scheduling and managing of deliverables associated with sponsor protocols and clinical trial sites.  The Clinical Trial Associate will work with sponsor requirements utilizing the project specific SOW, protocols and other data to identify requirements to assist with planning, budgeting, estimating enrollment requirements and forecasting.

The Clinical Trial Associate will work in close collaboration with the Project Management team of SUMMIT

Key tasks:

·         Assist in the preparation, handling, distribution, filing, and tracking of clinical documentation and reports

·         Assist in preparation and documentation of internal and external meetings by preparing agendas and minutes

·         Assist in updates for all clinical trials tracking tools

·         Assist in maintaining internal trackers for clinical study activities and study documents

·         Serve as administrative point of contact for internal teams and for external sponsors and CROs

·         Coordinates distribution and shipment of study-related materials

·         Provides general support to the Project Management team on other clinical trial related duties and tasks, as required

·         Maintains central registry of contact information for clinical sites, CROs, vendors and sponsors

·         Assists with the organization of internal team meetings, and other trial-specific meetings

Requirements:

·         2 years of experience in Clinical Research

·         Ability to synthesize data, with strong attention to detail and accuracy

·         Strong knowledge and understanding of ICH Guidelines, FDA regulations, and GCPs

·      Excellent written and verbal communication skills. Capable of developing precise, accurate written and verbal communications

·         Ability to effectively work across multiple projects, and with multiple organizations in a professional manner

·         Excellent reporting skills

·         Must be able to identify and take appropriate initiative to fulfil the requirements of the role, and possess the ability to maintain a high level of productivity with minimal supervision

·         Must be able to manage multiple priorities

·         Strong Organization skills

·         Strong computer skills (efficiency in Microsoft Word, Excel, Access and PowerPoint)

Supervisory Responsibilities:

There are no direct supervisory responsibilities for this position.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Language Ability:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Math Ability:

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Office, Microsoft Excel, Explorer, Google Chrome, Mozilla Firefox, web based enterprise solutions, and project management software.

Specialized Training:

·         CITI training certification

·         GCP training certification

Certificates and Licenses:

Valid driver’s license and personal auto insurance

Physical Demands:

The physical demands described here are representative of those that must be met by an 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, walk, sit, use hands, reach with hands and arms, and talk or hear. The employee is occasionally required to stoop, kneel, crouch or crawl, and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color.

Work Environment:

The work environment characteristics described here are representative of those an 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.

While performing the duties of this job, the employee is rarely exposed to blood borne pathogens.

The noise level in the work environment is usually moderate.