Senior Clinical Research Associate - Embakire

Description

Senior Clinical Research Associate

Manage and monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.

Responsibilities:

Manage and monitor clinical trials independently, across multiple studies, to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines

Provide input on clinical study documents such as Protocols, ICFs, Source Documents, and Monitoring Plans

Initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites

Identify study-related issues, confirm resolution, and ensure proper documentation through event system

Record site visit activities, including but not limited to, observations of clinical conduct, instructions/training given to sites, and action items to be completed as required by OPs or other contractual obligations

Review and verify accuracy of clinical trial data collected, either onsite or remotely, including query resolution

Assist with generating contents list of Enrollment Kits and other Study Supplies, as requested

Facilitate supply management and ensure clinical sites have necessary supplies to conduct studies according to applicable protocols

Assess IP accountability, dispensation, and compliance at the investigative sites

Ensure all required training is completed and documented

Perform essential document site file reconciliation

Ensure maintenance of essential documents in TMF to facilitate timely transfer to client

Serve as main contact for project-specific communications with investigative sites

Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues

Provide regular site status information to team members, trial management, and updates trial management tools

Participate in team meetings with clients, as needed, and keep project team members informed of study progress, issues and potential timeline delays by preparing weekly updates, as requested

Research and learn project indication

Serve as resource for and interact with other functional areas to resolve site issues and facilitate trial timelines

Analyze process workflow; implement operational changes in coordination with Sr Management ?May be assigned additional Clinical Operations tasks

Help create a fun, rewarding and collaborative environment

Education/Skills:

5 years of Clinical Research experience; IVD experience preferred

Bachelors degree in the Life Sciences or related field required, or equivalent

Pursuing a certification as a CCRP or CCRA through recognized professional organization

Thorough knowledge of GCP, GLP, ICH guidelines and other U.S. and international clinical regulatory requirements

Strong work ethic and demonstrated ability to deliver assignments on time

Ability to travel (up to 80%)

Ability to handle difficult situations professionally and maintain a professional and caring demeanor

Proven ability to collaborate in a team environment and work independently

Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment

Must be responsible, creative and highly motivated

Works Closely With: CTAs, Clin Ops Specialists, CRAs, Reg CRA Supervisors, PMs, Dir of Clin Monitoring Data Management, Sr Mgr of Clin Ops, Dir of Clinical Programs