Senior Clinical Research Coordinator

Job Description

Job Title:

Senior Clinical Research Coordinator

Position Description:

Subject matter expert and leader of a clinical operations team to conduct and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and Velocity's SOPs.

Position Reports To:

Site Manager/Site Director

Position Qualification Requirements:

Education:

* High School Graduate and/or technical degree

Experience:

* Minimum of 4 years of clinical research coordinator experience

Required Licenses/Certifications:

* Phlebotomy if applicable and required by state law

* Intravenous/Intramuscular dose administration and preparation if applicable and required by state law

Required Skills:

* Demonstrated knowledge of medical terminology

* Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.

* Ability to work in a fast-paced environment

* Strong verbal, written, and organizational skills

* Strong interpersonal and communication skills

* Ability to work as a team player

* Demonstrated ability to read, write, and speak English

* Ability to multi-task

* Ability to follow written guidelines

* Ability to work independently, plan and prioritize multiple deliverables and objectives

* Ability to be flexible/adapt as daily schedule may change rapidly

* Must be detail oriented

* Proficient problem solving and strategic decision making ability.

* Proficienct in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.

* Proficient leader, mentor and team builder

Required Physical Abilites:

* Sit or stand for long periods of time

* Travel locally and nationally

* Communicate in person and by a telephone

* Limited walking required

* Limited to lifting up to 30 pounds

Position Responsibilities:

* Lead a clinical operations team to execute clinical trials


* Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills

* Create training strategies and mitigation plans


* Conduct and manage clinical trials in accordance with the study protocol, GCP, and Velocity's SOPs


* Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.


* Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study

* Develop,?coordinate,?and implement research and administrative strategies to successfully manage assigned protocols.

* Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.


* Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries


* Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members


* Ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs.


* Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner


* Ensure staff are delegated and trained appropriately and documented


* Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.

* Incorporate understanding of how decisions affect the bottom line including links between operations and company's financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.

* Incoporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol

* Understand the disease process or condition under study

* Develop Quality Control strategies for team member projects


* Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope


* Other duties as assigned

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Signature

Date

Velocity Head of Department