Clinical Research Data Entry

Job Description

We are seeking a meticulous and organized Clinical Data Entry Specialist to join our team. This role is responsible for a variety of data entry tasks associated with clinical studies, ensuring compliance with Good Clinical Practice (GCP) guidelines, and supporting clinic and project management teams.

Responsibilities

• Retrieve and quality check source documents for assigned studies.
• Enter subject data from source documents into client databases in accordance with completion guidelines and study timelines.
• File source documents and perform quality control (QC) of case report form (CRF) entries.
• Track laboratory results and archive study documents.
• Prepare study binders for source document storage as instructed by the Project Manager.
• Support and perform QC of all source documents, both paper and electronic.
• Identify discrepancies in source documents and work with clinical staff for corrections or explanations.
• Evaluate query responses in eSource and reissue queries as necessary.
• Resolve or escalate queries within established timelines.
• Identify and communicate source document or electronic data capture (EDC) database issues to the Project Manager.
• Enter, track, and perform QC for Adverse Events and Concomitant Medications.
• Perform Adverse Event and Concomitant Medication counts (source vs. database).
• Perform QC for 100% of completed CRF entries.
• Ensure accurate and timely filing of all study-related documents.
• Ensure volunteer source document files/binders are ready for monitoring visits.
• Provide daily updates to the supervisor on the status of data entry tasks for assigned studies.
• Maintain records of entry/QC in tracker spreadsheets.
• Report protocol deviations promptly.
• Archive completed study documents according to established Standard Operating Procedures (SOPs) and Work Instructions.
• Account for unscheduled lab reports and perform QC/QA for lab data transfer files as assigned by the Project Manager.

Essential Skills

• Proficiency in Microsoft Word, Excel, and Office Suite products.
• High School Diploma or equivalent.
• Experience in data input and/or QC review.
• Ability to assume increasing levels of responsibility and perform effectively.
• Strong planning, coordination, organization, and prioritization skills to meet deadlines.
• Ability to interact successfully with team members and study participants.
• Self-directed with the ability to perform with minimal supervision.
• Attention to detail and thoroughness in task completion.
• Ability to read and understand protocols.

Additional Skills & Qualifications

• Experience in clinical research, electronic data capture (EDC), and data management.

Work Environment

This position requires on-site work. The work environment includes collaborating with clinical staff, managing documentation, and ensuring compliance with regulatory standards.

Pay and Benefits

The pay range for this position is $17.00 - $18.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Miami,FL.

Application Deadline

This position is anticipated to close on Mar 14, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $17 - $18