Research Data Manager

Employment: Clinical Research

Type: Full Time

Location: Houston, TX

"You can make a difference in the life of an oncology patient and find your career satisfaction by joining our team of healthcare professionals today."

About the Position

The Research Data Manager functions as an integral part of the conduct of clinical trials at Oncology Consultants. The Research Data Manager is involved in multiple aspects of the research process, depending on the individual’s experience, education, and specialty preparation. Under the general supervision of the Research Department Administrator, the Research Data Manager is responsible for the collection and reporting of relevant data on patients enrolled in clinical trials from the enrollment phase through follow-up care and study closure. 

SCOPE:

The Research Data Manager participates in clinical research activities at Oncology Consultants to include the entering of complete, accurate, and timely data for patients or subject on clinical research studies and study-related information into case report forms, paper or electronically.   Data management is performed in accordance with the trial protocols, procedures, guidelines, and professional standards of practice and responsible for training and supervising data coordinators.   All data must be complete, accurate, timely and must be in compliance with applicable internal and external policies, guidelines and regulations, including but not limited to those of the IRB, sponsor, CRO if applicable, FDA, ICH-GCP and Oncology Consultants. The Research Data Manager must be able to interpret the applicable regulations in order to ensure compliance.

Shift Schedule:

  • Mon - Fri: 8am - 5pm

Benefits:

  • Insurances: Life, medical, dental, short term and long term disability
  • 401K
  • Free parking
  • PTO
  • Holidays 
  • Competitive salary

Essential Duties and Responsibilities:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Oversees general activity involving clinical research data.
  • Responsible for data collection, analysis, and monitoring.
  • Responds to sponsor data queries timely as required by the study specific agreements.
  • Ensures data systems are operational and troubleshoots data submission errors.
  • Utilizes institutional and sponsor databases to record data
  • Obtains accurate medical information from patient’s medical records and enters the data in study specific data bases.
  • Prepares for sponsor monitoring visits
  • Meets with assigned study coordinator and investigator on a regular basis to review collected data and provide study updates.
  • Prepares weekly data reports to track data backlog and missing data.
  • Maintains logs/progress reports to track current and follow-up on participants
  • Assists with audits and regulatory inspections.
  • Participates in study initiation meetings.
  • Attends and participate in the sponsor calls and provides pertinent updates to the study sponsor team, Clinical Research Coordinators, Research Department Administrator, Principal Investigator and Research Department Director as appropriate.
  • Attends team meetings and individual weekly meetings with supervisor.
  • Develops and maintains professional relationships with the study sponsors, CRO as well as the Research Department and Oncology Consultant staff.
  • Participate in orientation and training of new research department staff
  • Participate in annual reviews
  • Ensures data management coverage for all active trials.

ADDITIONAL DUTIES AND RESPONSIBILITIES:                                  

  • Abides by the HIPAA regulations.
  • Maintains confidentiality of sponsor protocols and related documents.
  • Participates in educational and training activities as required by Oncology Consultants as well as study sponsors of the clinical trials.
  • Maintains GCP Certification per Federal Regulations.
  • Other duties may be assigned to meet business needs

EDUCATION/JOB REQUIREMENTS:

  • Degree in the life sciences or health sciences. Prefer Bachelor's degree.
  • Minimum of 2 years clinical research data entry experience.
  • Management experience 
  • Communicate effectively verbally and in writing

LANGUAGE SKILLS:

 

  • Proficient in written and verbal English

COMMENTS: This description is intended to describe the essential job functions, the general supplemental functions, and the essential requirements for the performance of this job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may

About Oncology Consultants

Oncology Consultants has been a premier adult medical oncology & hematology practice in Houston, TX for over 35 years. Our healthcare team is committed to provide state of the art cancer treatment in a caring environment as we continue to expand our oncology services in the metropolitan region.

Oncology Consultants is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.

Medical Center | Memorial City | Sugar Land | Katy | Willowbrook | Southwest Northwest | West Houston

Apply today. Our short application process takes less than 5 minutes with your phone, tablet or computer.