Clinical Research Associate I participates in the design, administration and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Being a Clinical Research Associate I ensures compliance with protocol and overall clinical objectives. Knowledge of FDA regulatory requirements is required. Additionally, Clinical Research Associate I may require ACRP or SOCRA Clinical Research Professional exam completion. Requires a bachelor’s degree in Science or its equivalent. Typically reports to a supervisor or manager. The Clinical Research Associate I work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Clinical Research Associate I typically requires 0-2 years of related experience.
Clinical Research Associate Job Description Template
Our company is looking for a Clinical Research Associate to join our team.
Responsibilities:
- Establishing regular lines of communication plus administering protocol and related study training to assigned sites;
- Perform remote query and data review as needed to assist CDM;
- Assist Study Lead with design and preparation of study related materials for the training of CRO staff;
- Act as CROs’ CRA/CTA first line of contact for study related questions/issues;
- Assist with Clinical Research investigator site trainings;
- Lead CRA team meetings, answers CRA study-related questions;
- Ensures site staff complete the data entry and resolve queries within expected timelines;
- Create adjudication packets under the supervision of study management;
- Responsible for reviewing data and documents related to study endpoints;
- Completes monitoring reports within two weeks of visit date;
- Prepare study specific informed consent form (ICF) template;
- Ensure timely resolution of all data queries remotely or at investigator site;
- Attends/participates in investigator meetings as needed;
- Participates in the selection and oversight of contract Clinical Research Associates (CRAs). Reviews reports and ensures timely resolution of issues;
- Perform site visits, co-monitoring visits to ensure protocol and regulatory compliance and effectively resolve site related issues.
Requirements:
- Ability to be discrete and maintain confidential information;
- Ability to work independently, be self-directed and demonstrate initiative;
- Exhibit good judgment and decision-making skills;
- Investigator site management experience (in either a CRA role or Study Coordinator role);
- BA/BS in science area, marketing, or business; or equivalent education/ relevant experience;
- Experienced in multiple Therapeutic areas a plus;
- Strong working knowledge of ICH-GCP;
- Able to make decisions independently and yet must be team oriented;
- Broad knowledge of medical terminology and clinical patient management;
- At least two years of on-site monitoring experience;
- Excellent communication skills (both written and oral) and the ability to build effective relationships with trial center staff and colleagues;
- Alternatively, you should have an equivalent combination of education, training and experience;
- Basic knowledge of drug therapy techniques and clinical research methodologies;
- Proven CRA experience;
- Background with drug/device combination product regulations and procedures is preferred.