Main Responsibilities and Required Skills for Clinical Research Coordinator
A Clinical Research Coordinator (CRC) is a professional who is responsible for coordinating and managing the day-to-day operations of clinical trials. They recruit and screen patients, manage study data, and monitor patient safety. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Clinical Research Coordinators.
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Main Responsibilities of Clinical Research Coordinator
The following list describes the typical responsibilities of a Clinical Research Coordinator:
Administer
Administer structured tests and questionnaires according to research study protocols.
Arrange
Arrange and conduct clinical research visits.
Assist in
Assist during all learning collaborative meetings.
Assist in all aspects of company start up activities as required.
Assist in creating and updating case report forms and / or source document templates.
Assist in creating and updating data spreadsheets.
Assist in maintaining relevant regulatory documents in partnership with the Regulatory department.
Assist in submitting and tracking adverse events and safety reports.
Assist in the collection, analysis and review of experimental data for publication and presentation.
Assist the regulatory department with Human subjects submissions, renewals, and safety reports.
Assist with daily workload planning.
Assist with interim and annual reports.
Assist with recruitment of eligible monolingual Spanish-Speaking participants for both studies.
Assist with study data quality checking and query resolution.
Assure
Assure study interventions are completed per protocol.
Attend
Attend conferences, seminars and meetings and may travel to sites to enhance study.
Attend site initiation meetings and all other relevant meetings to receive training on protocol.
Collect
Collect and compile patient and laboratory data for clinical research projects.
Collect and organize research data.
Collect, enter and manage research data; and assist with creating final reports.
Collect, process and ship laboratory specimens.
Collect and process biological specimens.
Collect, record, input and conduct quality checks on data entries.
Collect specimens from subjects and processes specimens as instructed.
Communicate
Communicate and develop acceptable resolutions to such obstacles.
Communicate safety concerns.
Communicate with external study sites to ensure protocol adherence.
Complete
Complete and maintain regulatory forms and critical documents / binders for Clinical Trials.
Complete case report forms.
Complete case report forms (paper & electronic data capture) and address queries.
Complete required and applicable research training needed to complete research.
Conduct
Conduct collection of study specimens and processing under direct supervision of PI.
Conduct informed consent / assent process.
Conduct lower to intermediate level study visits.
Conduct protocol training for clinical research staff.
Conduct regular telephone survey interviews with study participants at multiple time-points.
Conduct site qualifications, study initiation, monitoring and / or close-out visits.
Consent
Consent and enroll patients into clinical trials.
Coordinate
Coordinate and manage all the daily activities of the study.
Coordinate and submit IRB protocols, reports, revisions, updates, approvals.
Coordinate clinical trial enrollment activities at domestic and international participating sites.
Coordinate owner / patient compensation payments, sponsor invoicing, and collaborator payments.
Coordinate and participate in budgetary negotiations with industry sponsors.
Coordinate post-intervention surveys.
Coordinate protocol related research procedures, study visits, and follow-care.
Coordinate protocol related research procedures, study visits, and follow-up care.
Coordinate reimbursement of subjects.
Coordinate shipment of study material to and from study sites.
Coordinate space and supplies with appropriate personnel.
Coordinate study conduct with other departments to effectively implement clinical research projects.
Coordinate with Investigational Pharmacy for subjects to receive required drugs.
Create
Create and adhere to a data quality and quality assurance plan.
Create and completes study related documents and new study preparation.
Create and / or maintain all documents and records related to the study.
Create and / or update case report forms and / or source document templates.
Create, clean, update, and manage databases and comprehensive datasets and reports.
Create reports as requested.
Design
Design in-house testing protocols for evaluating new products and new product features.
Detailed
Detailed review of subject and study documentation, CRFs and source documents.
Determine
Determine eligibility of and gather consent from study participants according to protocol.
Determine & organizes patient's treatment and test schedules.
Develop
Develop and edits research data bases.
Develop and implement quality improvement program for data and sample collection procedures.
Develop and implement effective patient recruitment strategies.
Develop / Assist protocol specific flowsheets with strict adherence to protocol.
Develop informed consent forms, source documents worksheets and case report forms.
Discuss
Discuss study protocols with patients and verify the informed consent documentation.
Document
Document informed consent process and all components of protocol treatment.
Educate
Educate and mentor internal and external clinical staff, research teams and other coordinators.
Educate investigator staff and site staff on use of study devices and technology.
Educate subjects and family on protocol, study intervention, etc..
Ensure
Ensure accurate and complete data collection, entry, and timely submission to appropriate agency.
Ensure completion of contract requirements & client specifications.
Ensure study activities follow established protocol.
Ensure study is compliant with local and federal laws and regulations.
Ensure the diagnostic specimens are packaged per IATA guidelines.
Enter
Enter data and code in a data dashboard.
Explain
Explain and obtain the informed consent to the subjects.
Facilitate
Facilitate and / or leads research / project team meetings.
Facilitate monitor visits and database clean up with sponsor assigned CRAs.
Facilitate pre-study, site qualification, study initiation, and monitoring visit.
Facilitate study initiation, monitoring and close-out visits.
File
File and maintain regulatory application and documents.
Greet
Greet patients and explain the specimen collection process.
Help
Help arrange study visits and provide instructions to study participants / families.
Help triage patient questions.
Interact with
Interact and / or serve as a liaison with study Sponsors.
Interface with
Interface with departments to obtain UCSF approval prior to study initiation.
Interview
Interview participants and obtain social and medical histories.
Lead
Lead data analysis and work with collaborators on appropriate interpretation.
Learn
Learn and execute defined tasks while working closely with others.
Learn and utilize new products and tools, as appropriate, to successfully complete work assignments.
Learn health care authority regulations and guidelines and apply to daily activities.
Liaise with
Liaise between Research billing (CTFM) and the research team.
Liaise with physicians, nursing, and laboratory staff, as well as industry representatives.
Maintain
Maintain accurate source documents related to all research procedures.
Maintain adequate supplies and a contact to resupply stock when necessary.
Maintain all regulatory documents.
Maintain all study documents (regulatory binders, source documents, correspondence, etc.).
Maintain a thorough and meticulous working knowledge of protocol schemas and requirements.
Maintain confidentiality and demonstrate professionalism.
Maintain databases for tracking subjects for follow up.
Maintain inventory records of study related materials and equipment for multiple protocols.
Maintain OSHA standards on a daily basis for all exam rooms and laboratory.
Maintain research study binders with regulatory documents and patient data.
Maintain source documents and subject files in accordance with Mount Sinai policies and procedures.
Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
Manage
Manage conduct of experimental tests & procedures.
Manage day to day activities of clinical trials.
Manage essential regulatory documents.
Manage IRB protocol submissions and revisions.
Meet with
Meet with the Sponsor' s representatives to discuss the conduct of the study and review study data.
Monitor
Monitor / audit studies in accordance to study specific protocols and standard operating procedures.
Monitor subject safety and report adverse reactions to appropriate medical personnel.
Monitor the progress of research activities.
Negotiate
Negotiate prices and specifications with vendors.
Notify
Notify appropriate institutional officials of external audits by FDA and sponsors.
Notify direct supervisor about concerns regarding data quality and study conduct.
Obtain
Obtain informed consent from study subjects.
Order
Order and maintain equipment and supplies.
Organize
Organize and maintain all records required for recruitment for all clinical research studies.
Oversee
Oversee and coordinate the provision of administrative and staff services to investigators.
Package
Package and deliver specimens to various labs for processing.
Participate in
Participate in any internal and external audits or reviews of study protocols.
Participate in development of department SOPs, Equipment Binders, templates.
Participate in Environmental Chamber validations and maintenance.
Participate in evaluating patients for compliance related to protocol.
Participate in group planning of new research initiatives.
Participate in monitor visits and regulatory audits along with PI.
Participate in review and development of study protocols, BPSI SOPs, and internal procedures.
Participate in the collection, processing & evaluation of participant responses.
Participate in the informed consent process of study subjects.
Perform
Perform clerical duties in the preparation of regulatory documents.
Perform literature reviews, and present scientific findings at meetings.
Perform miscellaneous job-related duties as assigned.
Perform other clinical operations duties as assigned.
Perform other tasks as assigned and as training and experience allow.
Perform source documentation and data collection.
Perform subject screening.
Prepare
Prepare and administer study drug to veterinary patients.
Prepare and maintain study accrual statistics.
Prepare annual research ethics board renewals, amendments, and terminations.
Prepare data for analysis and data entry.
Prepare lab kits and requisitions prior to visits.
Prepare necessary paperwork and sample collection items.
Prepare project manuscripts and reports in collaboration as required by NIH or program committee.
Prepare scientific and regulatory documentation for submission to FDA or IRB.
Prepare study enrollment reports for staff meetings.
Prepare study sites for internal / external regulatory audits (sponsor, FDA, NIH, etc).
Prepare study updates / reports.
Present
Present trial concepts and details to the patients.
Process
Process blood and urine samples.
Process important study information.
Provide
Provide all job-related progress reports / technical reports as requested.
Provide backup coverage for other Clinical Trial Recruiters and Assistant CRCs.
Provide direct care to all study subjects within the standards set forth by the protocol.
Provide education regarding participation in clinical research.
Provide general project management support for clinical studies.
Provide in-service training to nursing staff on all investigational drug administration.
Provide medical care to patients, always ensuring patient safety comes first.
Provide resources, and consulting on difficult protocols or projects.
Provide resources for staff, patients, families.
Provide supervision and training to research assistants and summer students.
Reconcile
Reconcile internal bills, close human subjects program advances, etc..
Record
Record, report and interpret study findings appropriately to develop a study-specific database.
Record data on source documents and CRFs and / or electronic web based systems.
Recruit
Recruit and screen patients for clinical trials and maintain subject screening logs.
Recruit, instruct, and coordinate with research participants.
Recruit and screen potential study participants and performs intake assessments.
Recruit, screen, and interview study subjects, ensuring eligibility and understanding of the study.
Recruit, interview and enrolls patient.
Report
Report Adverse Events and Serious Adverse Events to appropriate department(s).
Report suspected non-compliance to relevant site staff.
Report study progress to investigators.
Respond to
Respond to correspondence, data and informational requests.
Review
Review and understand protocol, ensuring applicable regulations, and guidelines are followed.
Review, comprehends, and adheres to assigned study protocol.
Review, file, and respond to all study specific documents, correspondence, and requests.
Review Inclusion & exclusion criteria with the Pl or Treating physician to determine eligibility.
Review medical records and abstract data.
Review medical records and / or perform telephone or in-person interviews to gather data, as needed.
Review scientific publications regarding study.
Review subject charts with PIs.
Schedule
Schedule all patient research visits and procedures consistent with the protocol requirements.
Schedule and execute study visits and perform study procedures.
Schedule monitor visits and set up for monitoring visits prior to the monitor's arrival.
Schedule subject visits and procedures.
Screen
Screen all laboratory results when received and follow protocol procedure regarding abnormal results.
Screen, recruit and enroll patients / research participants.
Support
Support engineering team in evaluation of returned tests.
Support the Diagnostic Imaging department.
Support the safety of clinical research patients / research participants.
Track
Track progress across multiple programs and communicate this to internal and external stakeholders.
Train
Train new staff on recruitment protocols and techniques.
Type
Type memos and letters related to study activities.
Use
Use and promote safe behaviors based on training and lessons learned.
Work with
Work closely with both Post Award–Accounting and Sponsor regarding patient billing.
Work closely with vendors.
Work directly with investigators to review and implement study protocols.
Work with other sites in a multicenter clinical study.
Work with QC and QA during audits and audit follow-ups.
Work with Spring Loaded's research collaborators to design clinical outcomes research studies.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Clinical Research Coordinator:
Medical Terminology
Computer
MS Office
Art Electronic Medical Records
General Research Procedures
MS Outlook
Phlebotomy
Regulatory Requirements
Reports
MS Access
Medical Setting
MS Windows
Clinical Environment
Study-Specific Operating Procedures
Code of Federal Regulations
Human Subject Protection
Most In-demand Soft Skills
The following list describes the most required soft skills of a Clinical Research Coordinator:
Written and oral communication skills
Interpersonal skills
Organizational capacity
Attention to detail
Detail-oriented
Problem-solving attitude
Work independently with little direction
Analytical ability
Multi-task
Flexible with study assignments
Time-management
Meet deadlines
Organizational skill
Adhere to hospital confidentiality guidelines at all times
