Clinical Data Coordinator Job Description

Clinical Data Coordinator Job Description

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Clinical data coordinator provides data management support on clinical trials and ensuring that clinical data management activities are conducted in accordance with regulatory and company standards.

Clinical Data Coordinator Duties & Responsibilities

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

Sample responsibilities for this position include:

Obtain source documentation for patients enrolled into clinical trials
Responsible for overall knowledge of protocols as assigned by the Director, Clinical Trials Office
Prepare and provide patient status report as requested by the Director, Clinical Trials Office
Ensure complete clinical documentation, accurate medical coding, and proper reimbursement for the hospital
Coordinate activities focused on ensuring the accuracy and integrity of clinical data
Provide expertise in the areas of coding and classification systems to healthcare providers
Direct and evaluate the performance of assigned staff
Perform chart, internal/external coding and DRG reviews
Social media, website management, digital medial developer, digital content creator, outreach, develops written communication for outreach and education
Assist in defining and specifying clinically data collection requirements (such as eCRFs, CRFs, edit checks and collection of external data) for assigned studies

Clinical Data Coordinator Qualifications

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

Licensing or Certifications for Clinical Data Coordinator

List any licenses or certifications required by the position: RHIT, RHIA, CCS, CITI, ACRP, BLS, DOT, IATA, SOCRA, CRP

Education for Clinical Data Coordinator

Typically a job would require a certain level of education.

Employers hiring for the clinical data coordinator job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Nursing, Science, Education, Health, Mathematical Sciences, Biology, Chemistry, Allied Health, Medical, Associates

Skills for Clinical Data Coordinator

Desired skills for clinical data coordinator include:

Off-site SAEs per protocol
Clinical data management
Computerized information systems and standard application software
Excel and Word
More therapeutic areas
Drug development process
Effective clinical data management practices
Clinical trials data processing concepts
Medical terminology
Clinical trials

Desired experience for clinical data coordinator includes:

Supports CRC to meet industry/ investigator initiated trial data deadlines
Assist CRC with case report form completion
Assist CRC with query resolution
Assist in SAE reporting and tracking
Meets with clinical study sponsor representatives as requested
Maintains master patient list

Clinical Data Coordinator Examples

1

Clinical Data Coordinator Job Description

Job Description Example
Our growing company is hiring for a clinical data coordinator. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical data coordinator
  • Maintains study monitor calendar
  • Performs scientific data collections, reductions and analyses involving routine procedures characterized by moderate use of independent judgement
  • Provide test, header and production data to internal/external stakeholders according to data specifications
  • Position and management of systems is complex and errors in judgment would have a serious impact on the organization
  • Manages requests for data and provides comprehensive quality management reports including utilization, outcome studies and scorecards
  • Conducts data retrieval, aggregation, analysis and reports
  • Responsible for working collaboratively with the physician, nurse clinician, pharmacy and laboratory personnel to ensure tests/procedures/specimen collection, are obtained per protocol
  • Communication regarding patient data, status and protocol requirements with research staff
  • Responsible for all data completion
  • Attend study specific training to include but not limited to Study Initiation and Internal Kick-off Meeting
Qualifications for clinical data coordinator
  • Healthcare working experience
  • Minimum of 2 years’ experience working with an Electronic Health Record system
  • 1 year teaching experience
  • Bachelor's Degree in Computer Science, Informatics, Health Sciences, related field, or equivalent with a minimum of two plus years’ experience working in a clinical research environment or, an Associate’s Degree or High School degree with four plus years’ experience working as a Clinical Data Coordinator or in a comparable or closely related clinical research environment, including direct familiarity with data management processes in a clinical research environment
  • Experience with the U
  • Requires good organizational skills, attentiveness to detail, ability to work under general supervision and the ability to handle multiple projects simultaneously while meeting assigned deadlines
2

Clinical Data Coordinator Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical data coordinator. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical data coordinator
  • Research and resolve data discrepancies
  • Assist with the reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory)
  • Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory)
  • Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, ), and/or data inconsistencies that require further investigation
  • Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines
  • Supports CTS to meet industry trial data deadlines
  • Obtain source documentation for patients enrolled into clinical trial
  • Assist CTS with case report form completion
  • Assist CTS with query resolution
  • Create and maintain patient visit tracking spreadsheets for CTS
Qualifications for clinical data coordinator
  • Establishes positive, collaborative relationships with MedImmune peers, senior management and external vendors
  • Ability to work independently and collaboratively in cross-functional teams
  • Bachelor of science degree in nursing, allied health sciences, applied behavioral science, or related subject required
  • Bachelor’s degree in a science or health related field plus 2 years of applicable experience preferred
  • Ability to exercise independent judgment within generally defined practices and policies
  • Prior experience with various computer programs (Microsoft Office
3

Clinical Data Coordinator Job Description

Job Description Example
Our company is searching for experienced candidates for the position of clinical data 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 clinical data coordinator
  • Assigned special procedural projects to enhance the functioning of Drug Development Data Operations
  • Request and obtain regulatory documents, including informed consent forms, protocols and IRB approval letters, from external collaborators to ensure that all human tissues being studied at JAX have appropriate consent and regulatory approvals and that approval is maintained through the course of the study
  • Ensure compliance with regulations and internal and external policies governing data management and data systems, including good clinical practice (GCP), Food and Drug Administration (FDA), and JAX IT Security standard operating procedures (SOPs)
  • Prepare IRB submissions for assigned studies using the IRBManager e-submissions system once implemented and via pdf forms in the interim
  • Complete case report forms and maintain research records and source documentation per GCP guidelines
  • Develop skill in RedCap electronic data capture and database management system and support JAX investigators and staff in adoption of RedCap EDC for data management
  • Meet requirements for abstraction put forth by government, accreditation, and insurer requirements
  • Identify quality of care concerns and performance improvement opportunities as identified by specific UMMMC indicators
  • Reconcile data from multiple sources
  • Manage project timelines and quality
Qualifications for clinical data coordinator
  • Ability to relate effectively in person and via telephone and email with physicians, nurses, data managers, medical records and information science departments
  • Proficient in Microsoft Office software, including Word, Excel, and Access
  • 1 year experience as a Clinical Research Associate/Coordinator, Research Quality Monitor, or in a related area in data management working in a health care setting, preferably in research
  • Compile data
  • Use word-processing software
  • Minimum of two years of combined experience in clinical research, database development and management, RedCap, Medidata RAVE, or other EDC platform or an equivalent combination of education and experience
4

Clinical Data Coordinator Job Description

Job Description Example
Our growing company is looking for a clinical data coordinator. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical data coordinator
  • Coordinate all translations
  • Documentation - Receive and process (upload, assigning of attributes, filing, review and approval of subset of documents in CDC) required regulatory, legal and financial documentation in order to ensure successful study start-up
  • Receipt of core trial documents from all clinical functions and file in accordance with SMFI
  • Assembly & distribution of mass communications (MOP, Study Tools, Newsletters, Annual Reports)
  • Reconcile site training files
  • Manage site/contact/study information on appropriate tool
  • Processing incoming clinical data forms accurately and per departmental processes including data entry into a database, quality review and verification of forms already entered
  • Supporting discrepancy management effort by preparing data clarification forms based on review of incoming clinical data for missing or incorrect information
  • Identifying problems, creating case report forms and maintaining the integrity of information stored in the clinical database meta data study information
  • Providing administrative support for clinical studies and to the clinical evaluation department in preparation for on-site monitoring visits
Qualifications for clinical data coordinator
  • A favorable National Agency Check with Inquiries (NACI) is required
  • Microsoft Office software, including Word, Excel, and Access
  • Excellent communication and organizational skills, including attention to detail
  • Ability to travel up to four times per year to JAX’s Bar Harbor facility to coordinate on-site clinical research for Bar Harbor investigators
  • Bachelor’s degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification
  • 1-2 years of experience in a pharmaceutical or CRO setting preferred
5

Clinical Data Coordinator Job Description

Job Description Example
Our company is hiring for a clinical data coordinator. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical data coordinator
  • Assist in other quality control activities related to clinical data management
  • Responsible for clinical data management activities for studies and ensuring FDA requirements for quality databases submissions are met
  • Identifying causes of problems to prevent re-occurrence of problems
  • Keeping up-to-date on developments in field of expertise
  • Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance
  • Throughout the conduct of the conduct of the clinical trial assesses adherence to Sarah Cannon SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines
  • May perform data entry of a significant amount of information from electronic or hardcopy source materials such as patient demographics, clinical raw data and testing results into electronic databases and spreadsheets in accordance with project requirements as necessary
  • May assist with preparing or reviewing work instructions
  • May assist with preparing requirement/qualification documents and qualification testing for MIRTH channels
  • May interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables
Qualifications for clinical data coordinator
  • Associate’s Degree or two years’ of experience in a medical or clinical environment
  • 2-5 years of clinical data review experience (reviewing listings, opened and closed queries)
  • Must have RAVE experience
  • Data reviewing expertise
  • Data query/resolution expertise
  • Previous experience providing oral translation in a medical setting

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