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.
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Enterin is seeking to hire a Clinical Research Associate to join their growing team. This position 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.
This 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 distribution of 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 protocols.
- Minimum of 5 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.
Knowledge, Skills and Abilities (KSAs):
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. 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.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
The Clinical Trial Manager will direct and coordinate the operational and logistical activities necessary for the initiation and completion of clinical trials on time and on budget
- Responsible for managing activities associated with the conduct of assigned clinical trials.
- Develop and assist with protocols, consent forms, monitoring plans, case report forms, and other clinical documents related to clinical trials.
- Manage investigational sites and/or CROs to ensure compliance with protocol and overall clinical objectives; including traveling to sites to conduct pre-study, initiation, interim and closeout visits and/or co-monitor with CRO or contract associates.
- Negotiate contracts and budgets with clinical investigational sites and other vendors.
- Supervise clinical site monitors (internal and/or contract).
- Select and manage CROs and other consultants and vendors to ensure adherence to domestic and international regulations and standards (GCP and ICH).
- Participate in the review and update of existing procedures and develop new procedures as needed.
- Develop and maintain clinical project timelines.
- Interface with other departments within the organization to exchange technical data and negotiate courses of action on behalf of Clinical Operations.
- Lead study team meetings and update project management on a weekly basis of study timelines and activities.
- Perform other related duties as required to support Clinical Operations and Enterin.
- BS or equivalent experience in a scientific or medical discipline with 5 -10 years clinical trials management experience.
- Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors)
- Previous management or project management experience with demonstrated leadership ability.
- Excellent communication; interpersonal skills and influencing skills
- Ability to determine the people, funding, materials and support to meet project goals and timelines.
- Previous budget and contract negotiation experience.
- Knowledge of GCP .
- Ability to pro-actively identify and solve problems that threaten timelines and successful completion of clinical trials.
- Able to work independently.
- Excellent time management skills (timelines, schedules, task prioritization).
- Willing and able to travel up to 30% of time.