Clinical Trial Coordinator I/II - FSP

Join us as a Clinical Trial Coordinator 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 the 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 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.
• Maintain knowledge of Client systems.
• Keep 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 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 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.

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.
• 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 matrix environment.
• A proven relationship builder.
• An independent thinker.
• Ability to manage risk and perform risk escalation appropriately.

Schedule

Standard (Mon-Fri)

Environmental Conditions

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.

Pay

The hourly pay range for this position (Clinical Ops Delivery Associate I) based in North Carolina is:

• $20.00–$25.00 (CTC I)
• $22.00–$27.00 (CTC II)

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 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.