TMF Associate

We are looking for a Trial Master File Associate to join our team!

Are you well organized and adaptable to unexpected changes Do you have good computer skills and a knack for details If the answer is yes keep reading!

In this position you will:

• Contribute to the development and management of both paper and electronic Trial Master File (TMF) systems for clinical trials ensuring completeness accuracy and compliance with local federal and international regulations guidelines CPC Policies Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Upload study documents into various eTMF platforms (e.g. Cloudbyz Veeva BOX etc..
• Reconcile and conduct quality control (QC) for eTMF uploads.
• Ensure timely and accurate filing of essential documents in accordance with regulatory requirements and company SOPs.
• Collaborate with Study Teams to ensure effective implementation of TMF Management Plans.
• Assist in the creation maintenance and tracking of Trial Master Files for each assigned study.
• Reconcile and participate in the Quality Control of documents (paper and electronic) submitted to the TMF.
• Perform regular reviews and quality checks of the TMF to ensure completeness accuracy timeliness and consistency.
• Support the transfer of studyspecific TMF to designated parties.
• Manage closeout of TMFrelated issues and act as a point of contact for Study Team TMF questions in collaboration with the TMF specialist.
• Collaborate with team members to address any discrepancies or missing documents.
• Work closely with crossfunctional teams to ensure timely submission and retrieval of essential documents.
• Aid in the identification and resolution of documentation issues.
• Educate and support Study Teams and content owners on TMFrelated responsibilities.
• Identify opportunities for process improvements for TMF management including the development and update of SOPs and WIs and training materials as necessary.
• Collaborate with team members to implement QC initiatives for TMF activities ensuring continuous improvement in overall processes.
• Prepare and support TMFrelated audits and inspections by regulatory authorities ensuring all necessary documentation is readily available and compliant.
  

Heres what you will need to bring to the table:

• Bachelors degree preferred or equivalent knowledge/experience gained through a minimum of 1 year in a clinical research setting.
• Familiarity with applicable regulatory requirements (e.g. ICH GCP and FDA) for conducting clinical trials.
• Working knowledge of the DIA Trial Master File Reference Model and a demonstrated understanding of Clinical Trial records management best practices.
• Knowledge of clinical documents maintained in the eTMF.
• Previous experience in electronic Trial Master File systems and document management is preferred.
• Proficient in MS Office applications (e.g. Word Excel and Outlook).
• Excellent organizational and communication skills (both verbal and written).
• Strong problemsolving skills and detailoriented capable of managing multiple tasks with effective prioritization.
• A collaborative team player capable of interacting positively and educationally with individuals possessing varied skill sets.
  

Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $20.00/hr $23.00/hr

Deadline to Apply: May 1 2025

About CPC:

CPC is an academic research organization that offers full service clinical trial design oversight and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience CPC has provided services to over 150 clinical trials in a variety of indications with an emphasis on cardiovascular wound healing diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including Industry NIH and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active empowered and healthy. offers:

• Comprehensive benefits package (medical dental vision life STD LTD etc.
• Matching 401(k) plan (dollar for dollar up to 4 of your eligible compensation fully vested immediately)
• 11 paid holidays
• 15 25 vacation days based on years of service
• Paid sick time 2.67 hours accrued biweekly up to a maximum of 80 hours)
• Insuite exercise and relaxation room
• Monthly fun events (e.g. team building activities games charitable events potlucks picnics)
• Flexible and remote work schedules

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race such as hair texture and length protective hairstyles) sex color ancestry sexual orientation gender identity gender expression marital status religion creed national origin disability military status genetic information age 40 and over or any other status protected by applicable federal state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on jobrelated factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance please email our Human Resources team at.