Clinical Trial Coordinator I/II FSP

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

About the Role

• Excellent technical/IT skills, able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of Client systems/software
• Knowledge of relevant operational procedures, systems, and quality guidelines regarding clinical studies
• Able to work independently as well as in a team
• Professional attitude with good customer focus (internal and external)

Responsibilities

• Maintain up-to-date participating center’s information (including all contact details, contracts, and reports)
• Prepare Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies
• Assist Client study staff with maintaining the sponsor files during the life of the study
• Responsible for archiving at the end of study in accordance with relevant Client SOPs, policies, and local regulatory requirements
• Input and oversee Client clinical study tracking systems
• Proactively identify issues and raise them to Client study staff to take necessary corrective action to ensure smooth and rapid progress of studies
• Assist in the planning, logistics, and preparation of local Investigator meetings (travel arrangements, preparation, and distribution of study-related presentation material, etc.)
• Work with the Client Study staff for the management of study materials, non-IMP and IMP supplies—distribution, ordering, tracking, storage, reconciliation, and destruction using external vendor (details of destruction to be filed)
• Actively participate in clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge about the study, and be responsible for given tasks
• Assist Client study staff with study-related activities such as:
  • Organizing study meetings and scheduling travel
  • Producing minutes for study-related meetings
  • Assembling training and study materials
  • Updating contact details
  • Maintaining study documentation
  • Assisting in the preparation of documents and other tasks as required
• Maintain knowledge of Client systems
• Keep up to date with all changes/required knowledge on ICH GCP, Client written standards, and attend appropriate training sessions
• Support multiple studies simultaneously and prioritize appropriately to meet business needs
• Communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community

Requirements

Education and Experience

• For CTC I position:
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification (Bachelor's degree preferred)
  • Previous experience comparable to 1+ years
  • In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient
• For CTC II position:
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification (Bachelor's degree preferred)
  • Previous experience comparable to 2+ years
  • In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient

Skills and Abilities

• Ability to work in a team or independently, as required
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution, and closeout
• Excellent English language and grammar skills and proficient local language skills as needed
• Good presentation skills
• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete the organization’s clinical training program
• Self-motivated, positive attitude with effective strong interpersonal skills
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Fluency in local language as well as a good command of the English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a matrix environment
• A proven relationship builder
• An independent thinker
• Ability to manage risk and perform risk escalation appropriately

Pay

The hourly pay range estimated for this position based in North Carolina is:

• $20.00–$27.00 (CTC I)
• $22.00–$27.00 (CTC II)

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical, dental, and vision plans, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Schedule

Standard (Mon-Fri)

Environmental Conditions

Office