Clinical Research Coordinator

Vita Global Sciences, a Kelly Company; Austin (TX); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Full benefits

Medical

Dental

Vision

401K

Paid time off

Job summary

Kelly Science and Clinical FSP is seeking a Clinical Research Coordinator for a long-term engagement within our FSP division. The CRC will coordinate trial activities, maintain regulatory documents, and ensure compliance with GCP.

The role requires strong organizational and communication skills, ability to manage multiple trials, and collaboration with study teams, CRAs, and sponsors. For candidates with 3+ years in clinical trials and a Life Science degree, this full-time position offers

Qualifications

• Minimum 3 years of experience coordinating clinical trials.
• Knowledge of clinical trial terminology and practices is required.
• Ability to train others on key protocol elements and study task execution.

Responsibilities

• Coordinate efforts with study team members to achieve protocol objectives.
• Manage multiple concurrent trials and monitor study activities.
• Conduct the informed consent process and safeguard participant safety.
• Collect, document, and review essential study documentation and reports.
• Assist with site initiation, monitoring visits, and study close-out activities.

Skills

Clinical trial coordination

GCP knowledge

Relationship building

Communication skills

Prioritization

Education

BS/BA Life Science

CCRC certification a plus

Tools

MS Office

SharePoint

Job description

Kelly Science and Clinical FSP is currently seeking a Clinical Research Coordinator for a long-term engagement with one of our clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Job Summary

This individual will play a key role in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, the ability to prioritize, a "can-do" attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills.

Essential Duties

The CRC II will have overall responsibilities for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals, including:

• Develop strong working relationships and maintain effective communication with study team members.
• Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities.
• Manage multiple concurrent trials
• Assist with mentoring and training study team members
• Complete all protocol-related training
• Perform patient/research participant scheduling
• Collect patient/research participant history
• Collects and maintains source documentation
• Performs data entry and query resolution
• Collect and review required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging, and laboratory handling manuals, etc.).
• Adhere to an IRB-approved protocol
• Conduct the informed consent process of research subjects.
• Support the safety of research subjects, report adverse events
• Coordinate protocol-related research procedures, study visits, and follow-up and anticipate and mitigate potential non-compliance
• Assist with the screening, recruiting, and enrollment of research subjects.
• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close‑out activities
• Collect, process, and ship laboratory specimens
• Follow ethical and professional codes of conduct and elevate noncompliance as needed
• Communicate with Stakeholders: CRAs, Project Managers, Patient Services, Account Managers, healthcare practices
• Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified
• Comply with Company, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines, and documents data according to ALCOA

Working Conditions

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.

Requirements

Knowledge Skills and Abilities Required

• Minimum 3 years of experience coordinating clinical trials, including the activities listed above
• BS/BA in Life Science or related discipline or equivalent work experience
• Previous nursing experience in a clinical setting a plus
• CCRC certification a plus
• Demonstrated ability in positive relationship building, with strong verbal and written skills required.
• Knowledge of clinical trial terminology and practices required
• Demonstrated ability to coordinate complex protocols with overlapping timelines
• Prior GCP training and ability to explain importance of GCP guidelines
• Management of regulatory documents throughout trial lifecycleAbility to train others on key protocol elements and study task execution
• Able to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements and role of the IRB
• Strong interpersonal skills with attention to detail a must
• Follow ethical and professional codes of conduct
• Take action to minimize participant risk
• Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified
• Comply with Company, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines and documents data according to ALCOA
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems.
• Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.Strong organization/prioritization skills for the management of multiple concurrent projects

Posted By:

John Burgess