Clinical Trial Coordinator I/II FSP

Join us as a Clinical Trial Coordinator in a Functional Service Provider (FSP) model and 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.

About the role

This role operates in a standard office environment with a Monday to Friday work schedule.

Responsibilities

• Maintain up-to-date participating center 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.
• Archive study documents at the end of the 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, ensuring smooth and rapid progress of studies.
• Assist in the planning, logistics, and preparation of local Investigator meetings (e.g., travel arrangements, preparation and distribution of study-related presentation material).
• Work with Client Study staff for the management of study materials, non-IMP, and IMP supplies—distribution, ordering, tracking, storage, reconciliation, and destruction using external vendors. File details of destruction.
• Actively participate in clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge, and be responsible for assigned 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.
• Stay up to date with all changes and 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, and scientists, being mindful of their seniority within the medical and/or research community.

Requirements

• For CTC I position:
  • High 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 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

• 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; 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.
• Basic organizational and planning skills.
• Basic knowledge of local health systems.
• Ability to attain and maintain a working knowledge of GCP and applicable SOPs.
• 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.

Pay

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

• Clinical Trial Coordinator I: $20.00–$22.00
• Clinical Trial Coordinator II: $22.00–$27.00

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.

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.