Clinical Trial Coordinator I/II FSP

About the Role

Join us as a Clinical Trial Coordinator I/II FSP 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.

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.
• 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 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 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 about the study, 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/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, being mindful of their standing within the medical and/or research community.

Requirements

• 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

• 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.
• 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.
• 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 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 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.

Schedule

Standard (Mon-Fri)