Clinical Research Operations Manager Jobs in Michigan

Unique opportunity to make an Impact in the healthcare industry?

Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Nebraska North Carolina. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials.

As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us.

The role of a Clinical Research Coordinator builds upon the foundational responsibilities of an Assistant Clinical Research Coordinator, expanding into more autonomous management of clinical research activities with moderate supervision. This role requires a blend of specific certifications, detailed knowledge of clinical trial processes, regulatory compliance, and practical skills in managing both the operational and administrative aspects of clinical studies. Here?s a detailed overview of the responsibilities and skills required for a CRC:

Core Responsibilities:

1. Regulatory Document Management:

• Manage essential regulatory documents, including Institutional Review Board (IRB) submissions and safety reports, ensuring compliance with all regulatory authorities and guidelines (e.g., FDA, DSMB).

1. Data Management:

• Complete and maintain accurate source documentation and data entry. Address queries and action items promptly to ensure the integrity and timeliness of trial data.

• Perform E-source data entry and maintain real-time data accuracy, as applicable.

1. Regulatory Submissions and Communications:

• Submit necessary documents to regulatory authorities and/or review/monitoring boards, including DSMB and independent safety officers, in a timely and compliant manner.

1. Site and Study Visit Facilitation:

• Facilitate pre-study, site qualification, study initiation, and monitoring visits, as well as study close-out activities.

1. Team Coordination and Communication:

• Coordinate research/project team meetings, ensuring effective communication and collaboration among team members.

1. Specimen Management:

• Collect, process, and ship laboratory specimens following study protocols and regulatory requirements.

1. Patient Management:

• Schedule subject visits and procedures, ensuring participants' compliance with the study schedule.

• Conduct recruitment, pre-screening, screening, baseline enrollment, and follow-up visits, maintaining a participant-centered approach.

1. Inventory and Records Management:

• Manage inventory and maintain accountability logs for investigational products, devices, and study-related supplies.

• Retain records and archive documents after study close out, following regulatory guidelines and best practices.

1. Phlebotomy and Clinical Procedures:

• Requires Phlebotomy certification, indicating the ability to perform blood draws and other specimen collection as part of the study procedures.

Required Skills and Abilities:

• Effective Writing and Communication: Capable of clear and concise documentation, and excellent interpersonal communication skills for interactions with study participants, team members, and regulatory bodies.

• Teamwork: Ability to work collaboratively within a research team, contributing positively to team dynamics and supporting team members.

• Multitasking: Proficiency in managing multiple tasks and priorities efficiently, adapting to changing demands with attention to detail and accuracy.

• Regulatory Knowledge: In-depth understanding of clinical trial regulations, ethical guidelines, and compliance standards, with the ability to apply these in practical settings.

• Organizational Skills: Strong organizational and project management skills to oversee study activities, manage documentation, and ensure compliance with study protocols

Preferred Qualifications:

The preferred qualifications for a Clinical Research Coordinator 1 (CRC 1) typically encompass a blend of educational achievements, practical experience, and specialized skills that equip the individual to effectively manage and coordinate clinical research studies. Here is a detailed outline of these qualifications:

Educational Background

• Bachelor?s Degree: A bachelor's degree in life sciences, nursing, public health, or a related field is often the minimum educational requirement. This background provides a foundational understanding of biological principles, research methodologies, and ethical considerations in clinical research.

• Master?s Degree: A master's degree in a relevant field (such as clinical research, biostatistics, epidemiology, or healthcare management) may be preferred or allow candidates to enter the role with less practical experience, given the advanced knowledge and research skills acquired during their studies.

Professional Experience

• For Bachelor?s Degree Holders: Typically, 1-2 years of relevant experience in clinical research or a closely related field is preferred. This experience should demonstrate familiarity with clinical trial processes, regulatory compliance, patient interaction, and data management.

• For Master?s Degree Holders: No practical experience is necessary, but any internships, training, or exposure to clinical research during academic studies will be advantageous.

Skills

• Regulatory Knowledge: A thorough understanding of regulatory requirements and guidelines governing clinical research, including Good Clinical Practice (GCP), HIPAA, and IRB processes.

• Data Management Skills: Proficiency in data management software and systems, with the ability to perform accurate data entry, manage databases, and resolve queries.

• Communication Skills: Strong verbal and written communication skills are crucial for liaising with research participants, team members, regulatory bodies, and sponsors.

• Organizational and Multitasking Abilities: The capacity to efficiently manage multiple tasks and priorities, coordinate study activities, and maintain detailed records.

Personal Attributes

• Attention to Detail: Essential for ensuring accurate data collection, regulatory compliance, and adherence to study protocols.

• Problem-Solving Skills: Ability to identify issues and develop effective solutions in a timely manner.

• Adaptability: Flexibility to adapt to changing study requirements, protocols, and research environments.

• Teamwork: Demonstrated ability to work collaboratively within a multidisciplinary team, supporting colleagues and contributing to a positive work environment.

Additional Considerations

• Experience with Specific Populations or Therapeutic Areas: Depending on the focus of the research institution or the clinical trials being conducted, experience with specific patient populations or therapeutic areas may be preferred.

• Technology Proficiency: Familiarity with electronic health records (EHR), electronic data capture (EDC) systems, and other clinical research technologies.

These qualifications ensure that a CRC is well-equipped to handle the complexities of clinical trials, contribute effectively to research objectives, and uphold the highest standards of ethical and scientific integrity.

IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!