Senior Clinical Research Associate
The Senior Clinical Research Associate reports to and works under the direction of the Manager, Global Clinical Monitoring. Responsible to monitor clinical trials, study sites and clinical data while ensuring compliance with protocol and overall clinical objectives and Good Clinical Practice (GCP). Provides administrative and project support to clinical programs with minimum supervision. Interfaces with all project/clinical team members and off-site personnel as needed in support of project and departmental goals and responsibilities.
- Manages with limited oversight clinical study sites including managing study site start up, conduct and close-out
- Assists with the development and start-up of clinical studies as requested
- Provides feedback and input into some strategic operational development plans when requested
- Ensure, where relevant, that study sites follow site SOPs, protocols and GCP
- Prioritizes as needed to ensure on-time completion of assigned study deliverables (e.g. expense reports, monitoring trip reports, query resolutions, etc.)
- Assist with management and maintenance of clinical trial material to ensure clinical sites are supplied when needed
- Assists in the recruitment and mentoring of junior clinical research associates
- Understands the economic impact of decisions and maintains the awareness of the business needs
- Serves as a champion/proponent of technology and products while interfacing with site personnel and collaborators
- Aid in development of clinical study protocols and take ownership of their implementation where appropriate
- Ensures identified clinical study issues are resolved; implements and monitors corrective and preventative action
- Provides input into development of Case Report Forms when requested
- With limited oversight, facilitate the development of study-specific clinical trial
- Serve as primary point of contact for site questions relating to study enrollment, conduct and closeout issues; liaise with appropriate study team members as needed
- Support site selection process
- Participate in departmental organizational process improvement initiatives
- Attend meetings with external vendors, Investigative sites, Investigator meetings and scientific meetings as requested
- Maintain flexible approach to work as requested from time to time
- Interacts effectively with other project team members to ensure streamlined forward movement of clinical projects
- Assist in the preparation and execution of client bid defense meetings for new business
- Other duties as assigned by Manager, Clinical Monitoring Services
- Bachelor's degree in Life Sciences or related field (RN with evidence of further study considered)
- Minimum of three (3) to five (5) years of experience as a Clinical Research Associate in pharmaceutical and/or device trials.
- Certified Clinical Research Associate (CCRA) certification should be received within eighteen (18) months of hire. Once certification is obtained certification should be kept current.
- Sound knowledge of Good Clinical Practice and FDA regulations/guidelines for clinical research, ICH and ISO 9001. Demonstrates attention to detail and organizational skills, possess solid time management skills, pro-active and displays a professional demeanor with a high focus on compliance and responsibilities. Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date. Ability to work effectively in an innovative and flexible environment. Strong interpersonal skills and ability to work as an effective team member and with cross-functional groups
- Excellent English verbal and written communication skills. Ability to read and interpret documents such as regulations, SOPs, study protocols, medical terminology and equipment manuals. Ability to write routine reports and correspondence.
- Ability to handle multiple responsibilities and work well under pressure
- Self-starter committed to finishing projects completely while meeting project deadlines
- Growth oriented and is willing to go above and beyond given responsibilities
- Visibility of work requires attention to detail, excellent organizational skills, and discretion with confidential information.
- Ability to work well independently and on a team and drive work through internal support departments
- Ability to quickly build client confidence
- Must be willing to travel a minimal of 70% (domestic and internationally) with the intention of being on site a minimum of 8 days per month.
- Must be willing to work evenings and weekends as needed. Work requires willingness to work a flexible schedule.