Clinical Data Manager

You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Under the general direction of a Clinical Research Supervisor, our client is seeking a Senior Clinical Research Coordinator to handle the data management activities, communication, and team collaboration for multiple clinical studies. This role also involves oversight and training of junior staff as well as coordination of research meetings.

Responsibilities / Job Duties

• Train new research coordinators and support personnel in clinical trial procedures.
• Enter and update study data using the Clinical Trial Management System.
• Provide training and guidance to lower-level coordinators.
• Participate in the interview and selection process of new personnel.
• Act as a liaison between various clinical sites and community physicians.
• Document and report study treatment side effects to the PI and study staff.
• Coordinate laboratory functions and processing of protocol-required samples.
• Coordinate with investigators on the evaluation of patient care quality and protocol compliance.
• Serve as a single point of contact for patients and caregivers, facilitating patient care.
• Oversee preparation and accuracy of regulatory documents for IRB submission.
• Maintain compliance with Federal, State, and institutional guidelines.
• Participate in continuing education and professional development activities.

Skills

• Extensive knowledge of FDA and IRB regulations, ICH guidelines, and current Good Clinical Practice (cGCP).
• Proficiency with Clinical Trial Management Systems such as Velos or OnCore.
• Strong computer systems and database skills, including the use of electronic medical records and data capture systems.
• Excellent communication skills and the ability to engage in collaborative problem-solving.
• Ability to work independently and handle changes in priorities and deadlines.
• Strong judgment, initiative, and resourcefulness in decision-making.
• Good organizational skills and attention to detail.
• Ability to work effectively in a team and multi-task environment.

Schedule / Shift

Monday to Friday, 8:00 AM to 5:00 PM, with flexibility for early starts or early finishes. Ideally, work in-office Monday through Friday, but open to four days per week onsite.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

Required Employment / Compliance Language

Our client is an Equal Opportunity Employer and is committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements,

* We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).


Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we're dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

* As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.