Regulatory Affairs Associate Job at Baylor College of Medicine, Houston, TX

bUJZbTVsc1J6alIvYVRyVCtmYkUrKzU2dlE9PQ==
  • Baylor College of Medicine
  • Houston, TX

Job Description

Summary

The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with The Texas Children's Cancer and Hematology Centers (TXCH). This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This position requires expertise and understanding of clinical research and applicable regulations.

 

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

  • Coordinates regulatory correspondence across internal stakeholders and external institutions.
  • Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH.
  • Maintains and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
  • Maintains working knowledge of regulatory requirements through independent continuing education using guidelines, articles, and courses.
  • Develops and maintains positive relationships with institutional review committees and sponsor through oral and written communications.
  • Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.
  • Facilitates investigators in reporting and responding to institutional review committees' and other regulatory agencies' inquiries or comments.
  • Provides input to the investigators in consent form creation and protocol editing.
  • Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
  • Prepares for FDA meetings, inspections, and audits from regulatory authorities. Is available on site during audit visit to reply to auditor inquiries.
  • Handles aspects of more complex regulatory assignments including multi-site studies and Investigator held INDs .
  • Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
  • Assures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects.
  • Maintains regulatory database as applicable. Maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready.
  • Keeps the study team and supervisor informed of protocol related issues.
  • Participates in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other onsite meetings as required.
  • Assists with training of entry level employees as assigned.
  • Practices a high level of integrity and honesty in maintaining confidentiality.
  • Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.
  • Attends all required meetings and conferences, contributes pertinent protocol information and uses information presented to develop an understanding of the hematology/oncology landscape, in order to more accurately assist in the preparation of submissions.
  • Plans and pursues activities to promote self development related to hematology/oncology and regulatory issues. Looks for opportunities to improve performance; manages time, work, and relationships effectively and efficiently. 
  • Performs other job-related duties as assigned.

Minimum Qualifications

  • Bachelor's degree.
  • Two years of relevant experience.

Preferred Qualifications

  • Experience in regulatory affairs for clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.
  • Experience to include:
    • Demonstrated knowledge of regulatory processes and applicable regulations.
    • Ability to manage regulatory aspects of multiple research projects.
  • Certification in Clinical Research, SOCRA or other preferred. 
  • Ability to establish and maintain cooperative and mutually supportive working relationships with faculty, administrators, staff, other campus units, sponsors, their representatives, and other business partners.
  • Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.
  • Ability to serve as a resource to clinical investigators and staff.
  • Ability to manage shifting priorities in short time frames. 

 

 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

 

 

 

Job Tags

Local area, Shift work,

Similar Jobs

Shenzhen ATC Network Scienology Co.,Ltd

Network Promoter Job at Shenzhen ATC Network Scienology Co.,Ltd

1. Optimize title, keywords, descriptionbullet points of Amazon products.2. Write professional product reviews, new product promotion articles and festival promotion advertorials. 3. Take professional photography and video for product advertising, review videos, brand... 

Heidelberg Materials

Ready Mix Driver (CDL) - Oneida, NY Job at Heidelberg Materials

 ...Heidelberg Materials is seeking a Ready-Mix Driver in the Syracuse area at our Oneida, Central Square, Marcellus, and Nedrow locations. If you have a valid CDL Class A or B driver's license with industrial or construction driving experience, Heidelberg Materials wants... 

Sittercity

Babysitting, Babysitter Job at Sittercity

We need a babysitter to care for two young children, ages toddler (Calvin, 1.5) and Kindergarten (Robin, 5), starting August 18, 2025. The schedule is Monday to Thursday, from 2:30 PM to 4:30 PM. The sitter will need to pick up children from school, bring home, supervise...

Myerstown Nursing and Rehab

Registered Nurse (RN) Job at Myerstown Nursing and Rehab

 ...Assistance Program (EAP), Commuter Benefits, Paid time off (vacation, personal, sick, and state sick). Daily pay: The ability to freely view your paycheck as it...  ...factors such as pay classification (full-time, part-time, or casual), job grade, location, and length... 

CompHealth

Physician / Surgery - Pediatric / New York / Locum tenens / A Facility in NY Is Searching for a Locum Tenens Pediatric General Surgeon Job Job at CompHealth

 ...wait for license ~ BC or BE required ~ Days, Call, Weekend call ~62 patients per month, 174 operative cases per year ~ Pediatric surgery ~ Credentialing needed ~ DEA needed ~ We negotiate better pay and deposit it weekly ~ We arrange complimentary housing...