Clinical Research Site Director Job Listing at Kelly Services in Dallas, TX (Job ID 10116026)

Description

Clinical Research Site Director

• Opportunity: Full time – Direct Hire with our client 
• Type of hire: $100 -120k salary with benefit options
• Location: On-site Dallas TX

SUMMARY:

The Clinical Site Director is responsible for managing the overall business and clinical operations of the site to ensure that appropriate targets are met. The Clinical Site Director is responsible for managing the site's annual and forecast operating budgets and for the efficient coordination, organization and conduct of clinical trials. The Clinical Site Director oversees and manages all aspects of the clinical trial process including study feasibility, clinic staffing, patient recruitment, study conduct and regulatory compliance. The Clinical Site Director is responsible for ensuring the health and safety of study patients and staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.

• Work with the VP of Clinical Operations to manage the operational budget and meet/exceed the site's financial, operational, and study-specific targets.
• Maintain complete (24/7) control over the overall operations and management of clinical research trials at the site.
• Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business plan.
• Oversee the implementation and maintenance of quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs.
• Work with the Medical Director/PI to address any study and/or clinical quality related matters.
• Ensure timely and appropriate communications occur with Sponsors and IRBs as necessary.
• Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies.
• Oversee the development of the patient recruitment plan and patient outreach process.
• Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies.
• Manage the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development and responsibility. Responsible for ensuring the ongoing training needs of site staff members are met
• Establish and communicate performance expectations and guidelines to site staff members.
• Identify and manage issues, concerns and problems related to staff conduct and performance.
• Identify and build relationships with outside medical practices, pharmacies, and other health care professionals/organizations to aid in the patient recruitment process.
• Conduct business development activities on behalf of the site and with sponsors, CROs, CRAs and any third-party study vendors, as appropriate.
• Responsible for overseeing the proper reporting of site revenues, preparation of financial projections, invoicing to sponsors/CROs, and A/R collections.
• Share best practices with other site locations with the goal of raising the overall level of operational competencies.
• Ensure completeness, accuracy and timeliness of Feasibility Questionnaires, CDAs, CVs and essential regulatory documents from study start-up phase until site initiation.
• Attending industry and meetings relevant to the position of SD.
• Manage facility and IT needs to ensure smooth and efficient operations.

REQUIRED SKILLS/ABILITIES:

• Expertise in project management demonstrated ability to successfully manage people/projects. Proactive problem-solving abilities and follow-through.
• Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment.
• Successful decentralized team management and situational responsive decision making.
• Extensive knowledge of clinical research - Understands the drug development process.
• Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project.
• Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, team members and internal relationships. Ability to conduct effective presentations.
• Computer skills - Working knowledge of MS Office suite, Clinical Conductor CTMS and relevant CRM system. Able to generate business correspondence, create forms and generate reports as required.
• Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
• Ability to communicate effectively in English (both verbal and written).
• Up to 10% of travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
• Other duties as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor's degree preferred; Advanced degree suggested or equivalent clinical research experience.
• 5+ years of clinical management experience or equivalent applicable experience in clinical research industry
• Certificates, Licenses, Registrations: Maintain GCP & IATA certification and other on-the-job certifications as required.
• Travel Required: Estimated 10% office work

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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