Clinical Trial Coordinator I/II - FSP

Thermo Fisher Scientific • Morrisville, NC

16h • Hybrid

About The Position

Join Us as a Clinical Trial Coordinator I/II - FSP – Make an Impact at the Forefront of Innovation. 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.

Requirements

• 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)
• For CTC I position: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years). 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.
• For CTC II position: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). 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.
• 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 organizations 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
• Excellent interpersonal skills
• 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 team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of local health systems
• Ability to attain and maintain a working knowledge of GCP and applicable SOPs
• Excellent customer focus
• Proven flexibility and adaptability
• Ability to work in a matrix environment
• A proven relationship builder
• An independent thinker
• Ability to manage risk and perform risk escalation appropriately

Nice To Haves

• Bachelor's degree preferred.

Responsibilities

• Maintain up to date participating center’s information (including all contact details, contracts and reports).
• Responsible for preparing the 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 identifies issues and raises 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, assist with preparation and distribution of study related presentation material etc.)
• Responsible for working 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.
• As an active participant of 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.
• Keep up to date with all the changes/required knowledge on ICH GCP, Client written standards and attending appropriate training sessions.
• May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.
• Requirement to 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.

Benefits

• A choice of national medical and dental plans, and a national vision plan, 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 our 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED