Job Title: Clinical Research Data Coordinator (Head & Neck)

Job Description

The primary purpose of the Clinical Research Data Coordinator (Head & Neck) position is to assist in the development and maintenance of a system for controlling paper flow for protocols, and dissemination of data resulting from the protocols. This includes the completion of data forms, treatment records, and review of records before submission to pharmaceutical companies, federal agencies, internal groups, and other institutions. The role also involves coordination of communication between these groups and department physicians regarding research studies.

Responsibilities

• Abstract and collect patient data from electronic health records and other relevant source documents.
• Ensure high quality data management, including tracking receipt, QA, and entry of patient data; entering protocol data into the appropriate database(s) and generating queries for missing or incorrect data.
• Issue nursing/CSC/PI queries, track query return, and follow-up on all delinquent requests.
• Perform ongoing and concurrent review of data to ensure completeness and accuracy; address data entry omissions or inconsistencies and amend errors in a timely manner.
• Assist in database coordination, build, and maintenance for all IIT/IND studies utilizing an institutional database.
• Develop and maintain systems for controlling data flow; develop spreadsheets or other tracking tools for data that cannot be entered into a database.
• Provide data for study progress and patient safety reports, such as IRB continuing reviews and IND reports.
• Create accrual and/or toxicity reports as needed; assist in the collection and evaluation of protocol data and compile protocol data for statistical review/manuscript submission.
• Utilize different institutional databases to obtain and verify patient and protocol information.
• Record data specific deviations to deviation logs as indicated by sponsor request and other governing entities.
• Assist research staff with creation of new user accounts and database support on assigned studies.
• Follow and adhere to national/state, institutional, departmental, and sponsor guidelines to accomplish and complete daily work assignments.
• Prepare protocols for close out visits and termination.
• Consult with principal investigators and other department personnel regarding ongoing studies; gather and report appropriate information.
• Participate in protocol site initiation/logistics meetings and attend departmental or institutional research meetings as well as approved off-site meetings or conferences.
• Process requests for protocol-specific shipments of materials and investigational agents.
• Submit requests for image uploads to sponsor vendor entities and follow-up as necessary.
• Coordinate and communicate frequently with other research staff to identify and address any study-related issues.
• Develop templates/processes to ensure all information needed for data capture is documented.
• Inform research staff and others on upcoming deadlines to ensure data is completed.
• Act as a liaison between the research team, sponsor, CROs, other institutions, and agencies to ensure data is captured accurately and appropriately.
• Maintain a level of professional expertise and credibility through attendance at both institutional and outside continuing education programs.
• Track and manage all relevant protocol paperwork and essential documents.
• Demonstrate excellent oral and written communication skills when contacting other institutions and agencies.
• Coordinate and participate in monitoring visits and internal or external audits to ensure objectives are met.
• Review CD/Zip files of completed data points for preparation of study close-out/termination.
• Maintain adequate supplies for research record storage.
• Prepare terminated trials for warehousing.
• Other duties as assigned.

Essential Skills

• High school diploma or equivalent. A Bachelor's degree is preferred.
• Two years of related experience, or no experience required with a preferred degree.
• Clinical research and data coordination experience.
• Oncology therapeutic experience is a must.
• EPIC experience is a huge plus.
• Ability to handle 100 basic queries, clearing 50/60 within 3 hours and 100 per day when up to speed.

Additional Skills & Qualifications

• Experience in complex therapeutic areas such as neurology or cardiology.
• Familiarity with institutional databases like PDMS, CORe, PDOL, and the EHR (OneConnect [Epic]).

Work Environment

The role will be based in an office setting. The position supports one of the largest oncology clinical research sites in the world, offering a significant opportunity for career growth and development.

Pay and Benefits

The pay range for this position is $20.00 - $25.00/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 hybrid position in Houston,TX.

Application Deadline

This position is anticipated to close on Apr 8, 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 : $20 - $25