At Enterin, we are pioneering the medical community’s understanding of the link between infections, dysfunction of the enteric nervous system (ENS) of the gut, and the early onset and chronic progression of neurodegenerative disease.
To apply for any of the career opportunities shown below, please send your resume and an optional cover letter to firstname.lastname@example.org. Please note in the Subject line for which position you are applying. We will try to respond to each applicant within a reasonable period of time, although please recognize that depending on the volume of applications, we may not be able to respond to each applicant. Thank you for your understanding and for your interest in working at Enterin.
Enterin is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Enterin does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Enterin from recruiters do not constitute any type of relationship between the recruiter and Enterin and do not obligate Enterin to pay fees if we hire from those resumes.
Posted January 24, 2019
The Clinical Research Associate role will support the Clinical Trial Manager/Operational Team in executing the trial(s) and maintaining effective communication with project teams to ensure alignment with study timelines.
The remote role will conduct routine site monitoring visits and participate in site selection, site initiation, and study closure activities in compliance with Good Clinical Practice (GCP), company Standard Operating Procedures (SOP’s), and all applicable regulatory requirements.
- Evaluate, initiate, monitor, and close tasks associated with the management of clinical sites
- Ensure conduct of all clinical studies is in accordance with GCP’s, International Harmonization Guideline, and appropriate SOP’s
- Serve as primary contact for CROs/vendors, Investigators, and study coordinators for study related questions
- Collaborate with study team to support feasibility and site selection process for clinical studies
- Develop and maintain study-related clinical documents and tracking tools to support management of clinical studies
- Manage patient recruitment strategies to increase patient randomization into the trial
- Review all AE/SAEs and ensure appropriate documentation is recorded and safety issues are addressed and communicated
- Assist and support data validation and data cleaning procedures to meet timelines
- Order and coordinate study supplies for clinical studies
- Plan and participate in Investigator meetings and CRA trainings
- Conduct co-monitor activities at clinical study sites with CRO/CRA’s to verify adherence to GCP’s, SOP’s and study protocol
- Minimum of 2 years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock required
- Minimum of 1 year of experience in CNS monitoring Phase 1-3 pharmaceutical/ biotechnology clinical trials preferred
- Detailed understanding of ICH guidelines, GCP’s, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
- Good knowledge of concepts of clinical research and drug development
- Strong working knowledge of EDC, IVR and CTMS systems
- Ability to travel 50-70% (based on business need)
- Bachelor’s degree or, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.