JOB TITLE – Data Entry Assistant

GENERAL SUMMARY OF DUTIES – Provide direct support to the organization in the completion of data entry, query resolution, and related tasks while observing strict adherence to ICH, GCP, protocol, in addition to ACMR processes, policies, and additional guidelines.

MANAGER – Clinical Trial Manager (CTM)

DUTIES INCLUDE, BUT ARE NOT LIMITED TO:

• Ability to perform timely and accurate completion of electronic data entry for data points obtained and documented by the Clinical Operations Department
• Complete data entry within site or sponsor specific timelines and deadlines
• Accurately resolve queries data queries
• Communicate and escalate incomplete or missing data
• Communicate and escalate data point discrepancies
• Assist Quality Assurance Coordinators in the facilitation and completion of EAF’s, source submissions, and other study-related forms and documents
• Complete additional daily responsibilities delegated by QAC and QAM as they pertain to the study and/or study participants
• Other duties as assigned

KNOWLEDGE, SKILLS & ABILITIES – This position requires the following requirements:

• Interest in and knowledge of the clinical research industry and/or pharmaceutical research
• Ability to prioritize multiple demands and effectively manage time
• Ability to enter data correctly with attention to detail
• Excellent computer skills
• Advanced knowledge of electronic equipment (i.e., computer, e-mail, copier, phones, etc.)
• Skill in organization and record maintenance
• Skill in developing and maintaining effective working relationships with supervisors and co-workers
• Ability to react calmly and effectively in emergency situations
• Ability to interpret, adapt and apply guidelines and procedures
• Good interpersonal and communication skills
• Present a positive and professional approach

The ideal candidate will be an independent, critical thinker who is well organized and has a strong attention to detail. They should be able to perform the above duties in a fast-paced environment in a manner consistent with company goals. They must also be willing to adhere to the 7 guiding principles of our company.

Service Excellence: We believe all relationships with co-workers, sponsors, and subjects are partnerships. We demonstrate service excellence through a personal commitment to producing high quality, high value work, and delivering on time and on target results for every partner.

Safety: We believe that physical and psychological safety are foundational for a healthy organization. We proactively identify and mitigate safety risks as part of our daily work and value those who speak up for safety.

Resilience: We believe resilience is critical for doing our best work. We demonstrate resilience by remaining flexible, adapting to sudden change, and bouncing back from difficult situations with grace and confidence.

Team Orientation: We believe that having a team orientation leads to individual and organizational success. We demonstrate team orientation by working collaboratively and leveraging collective knowledge, ideas, and strengths to achieve a common goal.

Ethical Behavior: We believe the pillars of ethical behavior are integrity, honesty, respect, courtesy, and caring. We demonstrate ethical behavior by modeling professional standards of conduct.

Mutual Respect: We believe that mutual respect cultivates a supportive workplace. We demonstrate mutual respect by embracing diverse perspectives, sharing ideas, and trusting in each other’s abilities.

Open Communication: We believe that open communication results in a rich and rewarding dialogue that allows for the flow of energy and creativity. We demonstrate open communication by listening for understanding, speaking up without fear, freely sharing experiences, and soliciting ideas and opinions from others.

EDUCATION – BA/BS

EXPERIENCE – One (1) year experience in clinical research and data entry experience preferred but not required. This is a Entry-Level position

CERTIFICATE/LICENSE – GCP training provided. Other training will be provided on an as needed basis.

PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00a.m. to 4:30p.m. Research Assistants may be required to complete job-related tasks outside of that time frame in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping, and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-born pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.

As permitted by applicable law, COVID-19 vaccination is a requirement of employment at CenExel
Clinical Research and all its research sites. New hires are expected to have at least one dose of a COVID-
19 vaccine before their first day of employment.

Experience

• 2 - 3 years: Advanced knowledge of electronic equipment (i.e., computer, e-mail, copier, phones, etc.)

• 1 year(s): Clinical research and data entry experience preferred but not required

Education

• Bachelors or better

Skills

• Analytical skills
• Accuracy
• Ability to learn

Behaviors

• Team Player: Works well as a member of a group
• Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well