Senior Clinical Research Coordinator

Thermo Fisher Scientific • Evansville, IN

1d • Onsite

About The Position

Join us as a Sr. Clinical Research Coordinator - And play a key role in overseeing clinical site activities and ensuring high standards of patient care and data integrity.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• BLS certificate required.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’)
• Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment

Nice To Haves

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Responsibilities

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provide medical care to patients, always ensuring patient safety comes first.
• Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but are not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Record all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance with relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attend site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/complete information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gather and maintain source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adhere to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
• Performs clinical assessments of participants, monitors laboratory safety reports, and communicates any serious or potentially serious adverse events as per the company procedure.
• Serves as a primary point of sponsor contact for all research activities for studies assigned.
• Ensures all communications are documented and shared with the appropriate team members.
• Acts as a back-up to direct people manager. This includes but is not limited to, overseeing and assigning work to team members, scheduling, and monitoring time.
• Involved in the interview and hiring process of new team members.
• Assists in the training of new team members and provides mentoring.
• Provides input into evaluations performance reviews of team members

Benefits

• When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.
• As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers.
• Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer.
• Their work is a story of purpose.
• We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
• Thermo Fisher Scientific is an Equal Opportunity Employer.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior