Inhouse Clinical Research Associate
Novotech · Durham, NC
- On site
- Full-time
- $70,000 / year
- Durham, NC
Job highlights
- Support clinical teams with in-house research activities.
- Maintain crucial study documentation and TMF.
- Manage CTMS and ensure site compliance.
- Coordinate study materials and investigator files.
- Assist with site agreements and IRB submissions.
About the role
Role Summary
The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.
Key Responsibilities
- Support the clinical team's inhouse activities on assigned projects.
- Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.
- Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
- Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements.
- Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF's, ensuring accuracy and completeness of the data.
- Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study.
- Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
- May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
- May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase.
- May assist with site specific Clinical Trial Agreement (CTA) and budget negotiation. Prepare and amend the CTA within agreed negotiation parameters and policies. Work closely with the Project Management, Clinical Operations and Legal teams to facilitate timely execution of CTA.
- Prepare and update site Subject Visit Template (SVT)'s in accordance with site budgets.
Qualifications
- Relevant experience/qualifications in Life Sciences or related field or administration would be preferable.
- Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
- Entry to less than 2 years' experience as inhouse CRA or relevant roles
Salary Band
$65,000 - 75,000 Salary offered will be based on candidates experience level.
About Novotech
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
Key skills/competency
- Clinical Research Associate
- ICH GCP Guidelines
- Trial Master Files (TMF)
- Clinical Trial Management System (CTMS)
- Regulatory Requirements
- SOPs
- Documentation Management
- Audits
- Pharmaceutical Industry
- Healthcare Industry
Skills & topics
- Inhouse Clinical Research Associate
- Clinical Research
- ICH GCP
- TRIAL MASTER FILES
- CTMS
- Regulatory Affairs
- SOPs
- Document Control
- Pharmaceutical
- CRO
How to get hired
- Tailor your resume: Highlight experience in pharmaceutical, CRO, or healthcare industries and your understanding of ICH GCP and SOPs.
- Showcase relevant skills: Emphasize your experience with TMF, CTMS, and document management, aligning them with the Inhouse Clinical Research Associate role.
- Address qualifications: Clearly state your Life Sciences background or relevant administrative experience, even if entry-level.
- Express passion: Convey your enthusiasm for clinical research and biotech in your cover letter and during interviews.
- Follow up: As a Circle Back Initiative Employer, Novotech commits to responding to all applications.
Technical preparation
Familiarize with ICH GCP guidelines.,Learn TMF and CTMS system functionalities.,Practice document quality control reviews.,Understand regulatory submission processes.
Behavioral questions
Describe a time you managed multiple tasks.,How do you ensure accuracy in documentation?,How do you handle collaboration with teams?,Why are you interested in clinical research?
Frequently asked questions
- What are the typical working hours for an Inhouse Clinical Research Associate at Novotech?
- While specific hours can vary based on project needs and deadlines, the Inhouse Clinical Research Associate role at Novotech generally follows standard business hours. The company also emphasizes work-life balance with flexible working options.
- Does Novotech offer opportunities for career growth for an Inhouse Clinical Research Associate?
- Yes, Novotech is committed to the ongoing development of its team members. As an Inhouse Clinical Research Associate, you can expect opportunities for professional growth through development programs and potential advancement within the clinical operations team.
- What is the company culture like at Novotech for an Inhouse Clinical Research Associate?
- Novotech fosters an inclusive and respectful work environment, aiming to be an employer of choice for gender equality. They value passionate team members and support them with various benefits that contribute to a positive workplace culture.
- What specific technical skills are most important for an Inhouse Clinical Research Associate at Novotech?
- Key technical skills for an Inhouse Clinical Research Associate include proficiency in managing clinical study documentation within Trial Master Files (TMF), experience with Clinical Trial Management Systems (CTMS), and a strong understanding of ICH GCP guidelines and company SOPs.
- How does Novotech handle the application process for the Inhouse Clinical Research Associate position?
- Novotech is a Circle Back Initiative Employer, meaning they are committed to responding to every application. The process typically involves resume review, potential interviews, and a focus on understanding your qualifications and fit with their culture.
- What does 'in-house support' mean for an Inhouse Clinical Research Associate at Novotech?
- 'In-house support' means you will be working from Novotech's offices, providing essential administrative and coordination functions for clinical trial teams rather than conducting on-site monitoring visits.
- What kind of documentation is managed by an Inhouse Clinical Research Associate?
- An Inhouse Clinical Research Associate manages a variety of clinical study documents, including those within the Trial Master File (TMF), essential study documents, Investigator Site Files, and site-specific agreements like CTAs.