Research Assistant II - TMF

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 study-specific TMF to designated parties.
• Manage close-out of TMF-related 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 cross-functional 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 TMF-related 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 TMF-related audits and inspections by regulatory authorities, ensuring all necessary documentation is readily available and compliant.

  

Here’s what you will need to bring to the table:

• Bachelor’s 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 problem-solving skills and detail-oriented, 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: August 1, 2024

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. http://www.cpccommunityhealth.org/

CPC 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 bi-weekly up to a maximum of 80 hours)
• In-suite 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 job-related 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 careers@cpcmed.org.