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What is a CRA Project Manager?

A CRA Project Manager is a professional who oversees and coordinates clinical research projects, often within pharmaceutical or biotechnology companies or contract research organizations (CROs). They are responsible for planning, executing, and closing clinical trials in compliance with regulatory guidelines. Their duties include managing budgets, timelines, and resources, communicating with stakeholders, and ensuring the quality and integrity of the research data. CRA Project Managers also supervise clinical research associates (CRAs) and ensure that all trial activities adhere to protocols and Good Clinical Practice (GCP) standards.

What are the key skills and qualifications needed to thrive as a CRA Project Manager?

To thrive as a CRA Project Manager, you need a solid background in clinical research, project management expertise, and typically a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), regulatory compliance (such as GCP), and often a project management certification like PMP are highly beneficial. Strong leadership, problem-solving, and communication skills set exceptional candidates apart, especially when managing diverse teams and stakeholders. These skills ensure successful project delivery, regulatory adherence, and effective coordination of clinical research activities.

What are some common challenges faced by a CRA Project Manager when coordinating multi-site clinical trials?

CRA Project Managers often encounter challenges such as ensuring consistent communication across diverse research sites, maintaining regulatory compliance, and managing tight project timelines. They must address site-specific issues quickly while balancing the needs of sponsors, investigators, and regulatory bodies. Success in this role requires strong organizational skills, adaptability, and a proactive approach to problem-solving, as well as the ability to foster collaboration among cross-functional teams.

What is the difference between Cra Project Manager vs Clinical Research Associate?

AspectCra Project ManagerClinical Research Associate
CredentialsBachelor's degree, often advanced degrees, project management certificationsBachelor's degree in life sciences or related field, clinical research certifications
Work EnvironmentOversees multiple projects, manages teams, coordinates with sponsorsMonitors clinical trials at sites, ensures protocol compliance
Employer & Industry UsagePharmaceutical companies, CROs, biotech firmsPharmaceutical companies, CROs, clinical trial sites

The Cra Project Manager focuses on overseeing entire clinical projects, managing teams, and ensuring timely delivery. In contrast, a Clinical Research Associate primarily monitors clinical trial sites to ensure compliance with protocols. Both roles require related certifications and work within the clinical research industry, but their responsibilities and scope differ significantly.

What cities in Georgia are hiring for Cra Project Manager jobs?

Cities in Georgia with the most Cra Project Manager job openings:

Cra Project Manager jobs near you

Clinical Trials Coordinator

Atlanta, GA • On-site

Children's Healthcare of Atlanta
Hospitals • 10K+ employees
Learn more about Children's Healthcare of Atlantaexternal

$23.75 - $31.75/hr

Full-time

Posted 25 days ago

Key responsibilities

  • Coordinates the care of patients and families enrolled in clinical research trials within accepted practices, policies, and philosophy of Children's Healthcare of Atlanta.

  • Coordinates investigator-initiated and other clinical trials, including communication, regulatory, and research aspects.

  • Develops and oversees the conduct of research protocols, including study design, implementation, data collection, and ensuring reporting requirements are met.

Children's Healthcare Of Atlanta rating

7.5

Company rating: 7.5 out of 10

Based on 130 frontline employees who took The Breakroom Quiz

Job description

Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs).
Work Shift
Day
Work Day(s)
Monday-Friday
Shift Start Time
8:30 AM
Shift End Time
5:00 PM
Worker Sub-Type
Regular
Children's is one of the nation's leading children's hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We're committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children's.
Job Description
Coordinates the care of patients and families enrolled in clinical research trials within accepted practices, policies, and philosophy of Children's Healthcare of Atlanta. Coordinates investigator-initiated and other clinical trials, including communication, regulatory, and research aspects. Summarizes study accrual, toxicities, and other data to ensure appropriate documentation onsite and by participating outside institutions. Acts as liaison between the Data and Safety Monitoring Board and Principal Investigators to ensure that studies are regulated and reviewed appropriately for the program. Proactively supports efforts that ensure delivery of safe patient care and services and promote a safe environment at Children's Healthcare of Atlanta.
Experience
  • 3 years of clinical experience with knowledge about the conduct of clinical studies/trials, research principles, and methodologies/study design

Preferred Qualifications
  • Master's degree in Business Administration, Healthcare Administration, or a scientific field
  • Experience in creating and negotiating study budgets and contracts
  • Experience in database development and management
  • Experience managing complex projects

Education
  • Bachelor's degree

Certification Summary
  • Association of Clinical Research Professionals (ACRP), Certified Research Administrator (CRA) or Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professional (CCRP) within 1 year of hire
  • Collaborative Institutional Training Initiative (CITI) within 30 days of employment

Knowledge, Skills, and Abilities
  • Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor
  • Self-directed and motivated to work independently toward short- and long-term goals
  • Good communication, organization, and interpersonal skills

Job Responsibilities
Develops and oversees conduct of research protocols
  • Assists in the study design and implementation of new studies as requested/needed by the investigator
  • Develops, maintains, utilizes, and updates protocols, data collection tools, case report forms, spreadsheets, and databases for assigned studies.
  • Ensures all reporting requirements are met at participating sites.
  • Confirms patient eligibility from participating sites using eligibility checklists that are created for the project.
  • Conducts site initiation visits (SIV), interim monitoring visits (IMV) and close out visits (COV) for multi-centered studies in compliance with protocol requirements

Provides oversight for data and safety monitoring
  • Maintains the agendas and minutes for the Data and Safety Monitoring Board including scheduling ad hoc meetings.
  • Notifies the Data and Safety Monitoring Board chairperson of unexpected serious adverse drug reactions or serious adverse events.
  • Submission to appropriate regulatory bodies as needed.

Manages regulatory and administrative processes related to clinical research activities for multi-centered trials
  • Develops policies and procedures for the management of multi-centered studies.
  • Completes regulatory site accreditation and audit process of participating sites.
  • Oversees participating institutions to ensure that research and protocol activities comply with organizational guidelines and regulatory standards for multi-centered studies.
  • Serves as a resource for facilitating grants, contracts, and financial tasks for multi-centered clinical research projects.
  • Oversees the maintenance of sites' regulatory binders for purposes of Trial Master File (TMF) documentation.
  • Point of contact for participating sites contracts and payment to sites for study start-up, patient enrollment, and other study needs.
  • Works with study teams and investigators to ensure decisions are being met regarding amendments, dose escalation or de-escalation, suspensions/closures, and notification to regulatory agencies and sponsors.
  • Creates and upkeeps lay and web summaries

Completes data management activities
  • Participates in the development of databases to use as the coordinating center.
  • Develops and communicates project status reports and basic demographic and descriptive statistical information to multi-centered trials.

Performs quality and education activities
  • Provides leadership and training for all multi-centered clinical research activities.
  • Trains participating sites on all activities related to the research project such as eligibility criteria, enrollment instructions, reporting requirements, and monitoring plans including conducting Site initiation visits (SIV) and close out visits (COV).
  • Develops educational in-services for Children's Healthcare of Atlanta staff for assigned studies.

Children's Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.
Primary Location Address
1575 Northeast Expy NE
Job Family
Research

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