Study Coordinator Job Description

Study Coordinator Job Description

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Study coordinator provides research and analysis of data for a variety of processes and metrics used in department operations.

Study Coordinator Duties & Responsibilities

To write an effective study coordinator job description, begin by listing detailed duties, responsibilities and expectations. We have included study coordinator job description templates that you can modify and use.

Sample responsibilities for this position include:

Reviews study compliance against protocol, standard operating procedures (SOPs), and regulatory agency guidelines
Will carry out regulated laboratory studies to ensure compliance with the FDA Good Laboratory Practices (GLP) regulation
As Study 33 Coordinator, support a variety of laboratory-based activities associated with FDA regulatory compliance
Performs various duties, such as (1) develop standard operating procedures (SOPs), study-specific procedures (SSP), data forms, , (2) review protocols, study plans, and associated documentation for GLP studies, (3) participate in execution of laboratory and animal studies, to include non-primate studies, (4) organize and tabulate laboratory records and resulting data and analyzes data to ensure complete study files, and (5) assist with preparation of reports for submission to FDA
Assist investigators to ensure that PI-written reports are in compliance with appropriate FDA standards, , 21 CFR regulations
Assist principal investigators in developing documentation packages from laboratory studies that can support investigational and new drug applications (IND/NDA), as needed
Work effort can contribute to an array of FDA regulatory documents , Master File, IND, NDA/PMA
Supports advanced animal research, including studies under the FDA Animal Rule, by assisting with execution in compliance with GLP
Ensure integrity of the data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials
Identify potential clinical trial studies, determine suitability of Tripler AMC patient population based on inclusion / exclusion criteria and required timeline for study completion, and match sponsored studies with appropriate Principal Investigator

Study Coordinator Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Study Coordinator

List any licenses or certifications required by the position: CITI, IATA, IRB, ACRP, BSL, SOCRA, CCRP, CPR, CRC, MRI

Education for Study Coordinator

Typically a job would require a certain level of education.

Employers hiring for the study coordinator job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Communication, Human Relations, Education, Health Science, Public Health, Medical, Science, Psychology, Biology, Health

Skills for Study Coordinator

Desired skills for study coordinator include:

Excel
Medical terminology
Processes and tools used in department
Regulatory agency guidelines
Equivalent combination of education and experience
Psychology
Related field
SPSS
SAS
Microsoft Word

Desired experience for study coordinator includes:

Assist the PI with all Human Use Committee / Institution Review Board related requirements and any interface with clinical project collaborators or sponsors
Assemble and coordinate clinical trial study teams of study coordinators and other personnel needed to support the execution of the clinical study
Collect, organize, maintain, and disseminate appropriate files of data as required and assist with administration of the project, writing reports and manuscript preparation
Review patient records and identify potential eligible patients for inclusion/exclusion in the study
Interface with other departments throughout Tripler
For possible future prospective trials, the contractor shall oversee consent process, monitor and assess patient response therapy

Study Coordinator Examples

1

Study Coordinator Job Description

Job Description Example
Our company is growing rapidly and is looking for a study coordinator. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for study coordinator
  • Retrieve appropriate data from patient's written and electronic medical records and extract patient information from computer data base, x-ray results, and laboratory/culture results, inputting this data into appropriate forms
  • Provide written reports of analyses which include evaluation of the statistical limitations of the available data and delineation of possible explanations of the findings
  • For data sets that are considered routine, provide analyses within 1 week if data is provided by the investigator in electronic spreadsheet format
  • Supports the Department of Clinical Investigation (DCI), Tripler Army Medical Center (TAMC), working directly with the Chief or Deputy Chief DCI, Principal Investigator (PI) of the study and/or designated POC
  • Review patient records for eligibility in the study, screen study subjects and monitor subjects
  • Prepare files for statistical data analysis and provide documentation for written reports of the findings
  • Identify potential clinical trial studies, determine suitability of TAMC patient population based on inclusion/exclusion criteria and required timeline for study completion, and match sponsored studies with appropriate PI
  • Assist the PI and Study Coordinator Level II, with all Human Use Committee / Institution Review Board related requirements and any interface with clinical project collaborators or sponsors
  • Assist with the assembling and coordinating clinical trial study teams of study coordinators and other personnel needed to support the execution of the clinical study
  • Assist with the collection, organize, maintain, and disseminate appropriate files of data as required and assist with administration of the project, writing reports and manuscript preparation
Qualifications for study coordinator
  • Two or more years of experience in managing investigator-initiated, industry-sponsored, and military research protocols
  • Extensive experience with coordination of collaborative partnerships, establishing networks of investigators, and project management
  • Research regulatory compliance experience with Institutional Review Board approvals, Human Research Protection Plans, Data and Safety Monitoring Boards, Quality Assurance of Research Execution
  • Familiarity with statistical analysis and use of research electronic protocol submissions
  • For trials, oversee consent process, monitor and assess patient response therapy
  • Assure that all case reports are completed accurately and in accordance with study sponsor requirements
2

Study Coordinator Job Description

Job Description Example
Our growing company is looking to fill the role of study coordinator. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for study coordinator
  • For data sets that are considered routine, provide analyses within one (1) week if data is provided by the investigator in electronic spreadsheet format
  • Coordinate literature review for the construction of various best practice guidelines for the American College of Occupational and Environmental Medicine
  • Independently initiate and maintain collaborations with clinics, community centers, public health departments, and COVID-19 testing sites to promote study recruitment across Los Angeles County
  • Communicate the eligibility criteria to subjects, identify subjects who meet the criteria for the study, and perform informed consent to enroll
  • Act as point of contact for participants throughout study duration (~2 weeks per participant)
  • Maintain confidentiality and protection of participants
  • Document and immediately report any adverse events or unexpected problems during the study
  • Communicate COVID-19 presumptive positive results to participants in accordance with the approved IRB protocol, explain COVID-19 isolation practices, and direct participants to their local Public Health Department to acquire appropriate resources
  • Responsible for timely disbursement of compensation gift cards to participants at the completion of their enrollment period
  • Serve as the primary point of contact for study participants
Qualifications for study coordinator
  • A minimum of 1 year of experience in managing investigator-initiated, industry-sponsored, and military research protocols
  • A minimum of 1 year of experience with coordination of collaborative partnerships, establishing networks of investigators, and project management
  • Familiarity with statistical analysis and use of electronic protocol processing
  • Ability to analyze data and summarize findings for incorporation into reports
  • Demonstrated ability to manage documentation for multiple clinical trials, develop policies and procedures for clinical study execution and oversight
  • A minimum of 2 years of clinical study experience
3

Study Coordinator Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of study coordinator. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for study coordinator
  • Perform Informed Consent
  • Receipt and communication of study updates, data, documents
  • Will be required to work in a team environment individually with minimal supervision
  • Performs initial review of analytical data and originates noncompartmental analysis in support of pharmacokinetic and toxicokinetic studies
  • Aids in report preparation, including tables and figures
  • Participates in and assists 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
  • Proactively communicates and interacts with study team to ensure key milestones are achieved
  • Assists SD/PI in the PK/TK study phase, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines
  • Assists in the development and maintenance of standard report/table formats as required
Qualifications for study coordinator
  • Fluency in Spanish optional
  • Will be expected to work in biocontainment environments
  • A minimum of 3 years of experience in managing investigator-initiated, industry-sponsored, and military research protocols
  • A minimum of 3 years of experience with coordination of collaborative partnerships, establishing networks of investigators, and project management
  • Must be able to prepare oral and written presentations based on data analysis and study summary
  • Demonstrated ability to manage multiple clinical trials, develop policies and procedures for clinical study execution and oversight
4

Study Coordinator Job Description

Job Description Example
Our company is growing rapidly and is hiring for a study coordinator. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for study coordinator
  • Regularly manages increasingly more complex projects and study designs and/or increased study load
  • Prepares for and participates in routine client visits under direction of the SD/PI
  • Learns to expand responsibilities as a project coordinator for assigned clients(s) across the metabolism discipline
  • Prepares and proof required paperwork for document and/or supply shipments in a timely, efficient, and error-free manner
  • Prepares client-specific requirements for cover letters, inventories, or additional materials, as appropriate
  • Works with Study Coordinators (SCs) and Analytical Coordinators (ACs), as appropriate, to prepare, monitor, maintain, and understand the finalisation/archival scheduling mechanism and successfully performs applicable tasks around study archival
  • Notifies necessary personnel of study finalisation/archival
  • Assists in gathering required paper/electronic items for archival
  • Prepares and proofs required paperwork in a timely, efficient, and error-free manner
  • Proof tables and figures prepared by others
Qualifications for study coordinator
  • Bilingual in Spanish and English (written and spoken)
  • Prior experience translating study materials (Informed Consent forms, questionnaires, recruitment materials, informational sheets, ) from English into Spanish
  • Brief statement describing your (1) experiences performing human-subjects research, specifically your previous role(s) performing the Informed Consent process with human subjects (please omit any confidential details) and (2) previous professional experience working with vulnerable populations and/or individuals who are experiencing illness
  • Bachelor’s or Master's degree in Public Health or similar
  • Prior experience consenting participants for a research study
  • Prior experience maintaining HIPAA-protected data for a research study, or a similar role
5

Study Coordinator Job Description

Job Description Example
Our growing company is looking for a study coordinator. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for study coordinator
  • Successfully performs report to data QC of at least one study type
  • Drafts protocols, sample analysis outlines (SAOs), amendments and study scheduling, as appropriate, using proposal outline or client-supplied information
  • Communicates and interacts with various departments within, , working in collaboration with clients
  • Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, as required
  • Reviews QAU report audits
  • Prepare schedules for study-specific protocols
  • Prepare and/or verify test article/substance and required analysis information with Formulations Department for inclusion in the protocol
  • Generate study timelines for study reports
  • Provide internal QC via peer review of protocols
  • Track availability and scheduled receipt of test article/substance shipments to ensure study start
Qualifications for study coordinator
  • A bachelor's degree in a social or health science plus 2 years’ experience
  • 1-3 years of experience with Research and Data collection required
  • Current CITI certification in Responsible Conduct of Human Subjects Research and Biomedical Research or equivalent
  • Excellent communication skills and the ability to interact professionally with all levels of staff and human-subjects participants
  • Bachelor degree in science plus one year of Study Coordinator experience
  • Excellent interpersonal skills, , service skills (internal and external) including attention to detail, accuracy, confidentiality and communication skills

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