The Center for Cancer and Blood Disorders · 2 months ago
Clinical Research Department Manager
Fort Worth, TX
Full-time
Onsite
Mid Level
3+ years expThe Center for Cancer and Blood Disorders is seeking a Clinical Research Department Manager to ensure clinical trials are conducted in compliance with regulatory guidelines and company SOPs. This role involves supporting cross-functional collaboration with research teams and handling various tasks related to study setup, data management, audits, and financial oversight.
Health CareHospitalPersonal Health
Responsibilities
Throughout the conduct of the clinical trial, assesses and maintains adherence to company SOPS, Good Clinical Practice (GCP), and ICH regulations and guidelines
Maintains research records in a confidential manner according to practice policies sponsor requirements, HIPAA guidelines, and any other applicable regulations
Supports and collaborates with Research Team by providing accurate and timely data collection, documentation, entry, and reporting consistent with ALCOA principles
Serves as a liaison with clinical staff for management and issues related to clinical trial management such as collaborating with clinical staff and ancillary departments for protocol training, scheduling and care for enrolled subjects, distribution of study information to appropriate parties, etc., acting as subject matter expert (SME)
Serves as a point of contact for the sponsor and other entities involved in clinical research studies, promoting a proactive and professional relationship with external affiliates
Participates in meetings (departmental, hospital, investigator, etc.) that may require travel
Generates and contributes to the maintenance of departmental tracking and trending of metrics, platform management, process improvement, quality control, etc
Collaborates with Clinical Research Director and PIs for completion of study lead analysis, feasibility assessments, and study start up and maintenance
Collaborates with applicable staff for departmental financial and accounting management including invoice generation, budget review, and payment reconciliation
Assists with maintenance of regulatory and pharmacy activities and documents as needed
Prepares for and participates in audits conducted by study sponsors, federal agencies, or specially designated review groups, functioning as a means of quality control
Coordinates and participates in site selection visits, study initiation visits, monitoring visits, including facility tours, source document compilation and verification, etc
Assists with preparation and creation of source document templates in accordance with the protocol, case report forms, and electronic data capture systems, etc
When needed, assists in the preparation of documents for Institutional Review Board submission including informed consent, protocol amendments, safety reports, and other regulatory activities
Assists with development of department SOPs; provides suggestions for improvement
Performs other duties as necessary
Qualification
Required
Experience working as a nurse or healthcare professional in a clinical setting
Must have professional demeanor and strong communication skills with the public as well as physicians/researchers
Proficient in Microsoft Office software, including Word, and Excel; moderate level of computer literacy and ability to learn new software if required
Excellent English written and oral skills
Proven ability to multi-task in fast paced environment
Strong interpersonal, communication, and organizational skills
Ability to manage, organize, and seek advice to complete tasks in a timely manner
Degree in a science discipline from a college or university with a 4-year bachelor's; OR one to two years related experience and/or training; or equivalent combination of education and experience in conducting clinical trials
Society for Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification required following 2 years of employment
Current professional medical professional in the state of Texas if applicable
Masters or Nursing Degree: 3 years (Required)
Clinical trials: 3 years (Required)
Preferred
Oncology experience
Understanding of GCP and ICH regulations and guidelines
Detail-oriented with working knowledge of scientific, medical, and regulatory terms
Research experience with knowledge of the conduct of clinical trials
Hematology/Oncology experience
Willingness to travel: 25%
Benefits
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
Company
The Center for Cancer and Blood Disorders
The Center for Cancer and Blood Disorders was founded in 1994 by two groups of cancer specialists who had been in separate private practices for nearly fifteen years.
201-500 employees
Funding
Current Stage
Growth StageRecent News
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