Clinical Trial Coordinator I/II FSP

About this role

Job Title: Clinical Trial Coordinator I/II FSP
Job Location: Remote, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 biotech’s, 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
•…