Senior Clinical Research Associate Job Description Template
Our company is looking for a Senior Clinical Research Associate to join our team.
Responsibilities:
- Support and maintain documentation of all clinical research activities, e.g. site communications, correspondence, inventory information;
- Support maintenance of department SOPs and work instructions;
- Facilitates the Regulatory Compliance audit process, as needed;
- Oversee monitor activities at investigational sites;
- Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives;
- Supports investigators with study procedures;
- Ensure queries are responded to and closed in a timely manner;
- Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH and/or FDA GCP Guidelines;
- Uses multiple technologies to foster, maintain, and enhance open communication;
- Ensure timely close of all site action items;
- Ensures quality of data submitted from study sites and assures timely submission of data;
- Appropriately escalates serious or outstanding issues to line manager and project team members;
- Ensure site visits are conducted according to study budget;
- Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
Requirements:
- Knowledge of GCPs, CFRs and IRB procedures;
- Understanding of basic anatomy and physiology, electrophysiology and arrhythmias;
- Ability to travel up to 25%
- Ability to manage role/responsibility independently;
- Recognize problems, trends and react to resolve issue quickly and to bring effect resolution;
- Ability to regularly walk, sit, or stand as required;
- Strong attention to detail and an ability to prioritize and juggle multiple/competing issues;
- Experience with medical device and/or complex clinical trials desired but not required;
- Excellent written and verbal communication skills;
- Full command of the English language a must, additional languages (French, Spanish) an advantage;
- Able to interpret clinical data, meet deadlines and work effectively with all levels of employees;
- Passionate about new technology, with excellent cross cultural and presentation skills;
- CRA certification and demonstrated experience in medical device clinical studies a must;
- Ability to travel up to 50%. Overnight travel is required; International travel may be required;
- Ability to exhibit good judgment, be creative, and achieve aggressive goals.