Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
Role-related skills
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)
Role 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.
Knowledgeable of Client systems
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.
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 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.
Knowledge, 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 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
Working Conditions and Environment:
Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
Occasional drives to site locations. Potential Occasional travel required.
Compensation and Benefits
The hourly pay range estimated for this position Clin Ops Delivery Associate I based in North Carolina is $20.00-$25.00.
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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
This job posting is for multiple levels:
The salary range estimated for the second level is: $22.00-$27.00
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
