Discovery BioA Associate Study Coordinator

Labcorp • Madison, WI

2d

About The Position

We’re excited to offer a great career opportunity as an Associate Study Coordinator on our team in Madison, WI. Position Summary: Individual has responsibility for learning to coordinate the activities of routine and non routine studies in compliance with appropriate company standards, GLP, GCP, GMP and regulatory guidelines specified in the study plans, protocols, methods, or work agreements governing the work in which they are involved in a timely, efficient and quality manner. This role will need knowledge of discovery bioanalytical work, and the data collected by this analytical team.

Requirements

• Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers.
• Skilled in the use of all standard laboratory equipment.
• Skilled in the use of Documentum software.
• Skilled in the use of Watson software.
• At least 6 months of metabolism study coordination experience.
• Relevant degree plus 2 years of appropriate experience.
• Relevant experience may be substituted for academic qualifications.
• Consistently and continuously responds efficiently to requests (delivers high quality output on time)
• Builds positive relationships with both internal/external clients
• Uses experience and knowledge to contribute to design of new process or program in primary area of work
• Works with the team to identify obstacles to change
• Recognizes changing situations and priorities and adapts accordingly
• Follow instructions, SOPs and protocols that apply to current role to complete assigned tasks and projects
• Demonstrates ability and desire to learn and develop self
• Places organizational goals before personal interests and demonstrates the ability to engage in team building
• Supports and encourages others in their work
• Ability to schedule daily tasks to coincide with own study deadlines
• Ability to recognize deviations from normal results and inform Study Director and/or management of any problems that may affect integrity of the data
• Ability to understand the scope of a study (primary area of work) and be able to complete tasks with no or minimal supervision

Responsibilities

• Learns to draft protocols, amendments and study schedules as appropriate using study outline or client supplied information
• Learns to review study compliance against protocol, SOP and regulatory agency guidelines
• Learns to prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable.
• Participates in and learns to assist SD/PI with pre-initiation and other study related meetings as required
• Reviews progress and study status against initial work plan – maintains CMS with accurate schedules. Communicates and interacts with study team (SD’s and operational staff)
• Learns to serve as the primary contact in communication and interaction with other departments and clients as applicable
• Learns to maintain well documented, organized and up-to-date study files including study schedule, protocol and correspondence.
• Learns to assists SD/PI in monitoring in-life and analytical phases of studies, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.
• Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
• Learns to assist in interpreting and evaluating data for reports
• Participates in the peer review process for scientific reports
• Learns to review QAU report audits with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
• Reviews client comments with SD/PI and ensures that all necessary report/raw data clarifications are completed.
• Learns to manage increasingly complex projects and study designs
• Learns the process of report production through finalization, including archiving of data as appropriate.
• Learns to participates in routine client visits under direction of the SD/PI. Interacts/communicates with client as necessary.
• Maintains an awareness of the financial status of ongoing studies, including work scope changes
• Performs other related duties as assigned.

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.
• Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed