**[Clinical Research Coordinator]{.underline}**

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| ClinForce     | -   responsible for recruiting patients              |
|               |                                                      |
|               | -   handling regulatory documentations               |
|               |                                                      |
|               | -   getting files ready to be audited                |
|               |                                                      |
|               | -   work closely with an Oncology Group              |
|               |                                                      |
|               | -   responsible for identifying potential subjects   |
|               |     for the study                                    |
|               |                                                      |
|               | -   establish visits for the screening               |
|               |                                                      |
|               | -   assist with subjects getting started             |
|               |                                                      |
|               | -   assist with training of the site\'s CRC          |
|               |                                                      |
|               | -   work with data collections and data entry        |
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| Suburban      | Responsible for implementing sponsor protocols under |
| Research      | the direction of our psychiatrist                    |
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Study Coordinator

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| TKL Research  | -   understand and develop study protocols           |
|               |                                                      |
|               | -   responsible for IRB submissions                  |
|               |                                                      |
|               | -   performance and oversight of laboratory          |
|               |     procedures as needed                             |
|               |                                                      |
|               | -   coordinate workflow for planning                 |
|               |                                                      |
|               | -   maintain research studies                        |
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| AAIPharma     | -   Responsible for the successful conduct of        |
|               |     multiple ongoing clinical trials involving       |
|               |     patients or healthy volunteers.                  |
|               |                                                      |
|               | -   Must prepare all study related required          |
|               |     paperwork and any other form required to         |
|               |     accurately capture all data required by a study  |
|               |     protocol.                                        |
|               |                                                      |
|               | -   The study coordinator is also responsible for    |
|               |     all aspects of subject safety and cooperation    |
|               |     while in-house during procedures.                |
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| CureSearch    | -   Identify industry studies as they present        |
|               |     concepts in the Study Development Office (SDO),  |
|               |     maintain tracking database, identify the drug    |
|               |     companies and the type of agreement needed, and  |
|               |     determine the holder of IND.  Develop, maintain  |
|               |     and submit monthly status reports for each study |
|               |     to COG Leadership.                               |
|               |                                                      |
|               | -    Prepare and complete template drug company      |
|               |     agreement, and send it to the drug company       |
|               |     contact for review by their legal department.    |
|               |     Notify the COG Regulatory Affairs and Contracts  |
|               |     Offices that the standard agreement has been     |
|               |     sent.                                            |
|               |                                                      |
|               | -    Assist in developing a budget and payout        |
|               |     schedule in collaboration with the Chair's       |
|               |     office and Study Chair.                          |
|               |                                                      |
|               | -    Act as the primary contact for drug companies.  |
|               |     Coordinate the development of the scope of work  |
|               |     (SOW) between the Operations Center (GOC) and    |
|               |     drug companies.                                  |
|               |                                                      |
|               | -     Develop a study-specific tracking sheet        |
|               |     (checklist) of required duties to monitor and    |
|               |     assure that COG supplies data, reports to the    |
|               |     FDA or drug company, etc. at the time points     |
|               |     agreed upon in the SOW.                          |
|               |                                                      |
|               | -      Assist the SDO with the preparation of        |
|               |     responses for the reviews associated with        |
|               |     protocol development including NCI, COG Protocol |
|               |     Review Committee and the pediatric Central IRB.  |
|               |                                                      |
|               | -    Prior to study activation, review protocols,    |
|               |     case report forms (CRFs) and remote data entry   |
|               |     screens to ensure that all data collection       |
|               |     requirements are met as specified in the signed  |
|               |     agreement.                                       |
|               |                                                      |
|               | -    Coordinate the review of adverse event          |
|               |     reporting.                                       |
|               |                                                      |
|               | -    Train site personnel in all requirements for    |
|               |     participation that are beyond that expected for  |
|               |     COG studies of the same phase.                   |
|               |                                                      |
|               | -   Prior to the time points specified in the        |
|               |     tracking sheet, notify the appropriate COG staff |
|               |     that the data report, etc. is due, and will act  |
|               |     as the conduit to collect the materials and      |
|               |     forward to the drug company contact in           |
|               |     accordance with applicable policies and          |
|               |     procedures.                                      |
|               |                                                      |
|               | -   Manage the collection, scanning, storage,        |
|               |     retrieval and delivery of applicable regulatory  |
|               |     documents (e.g. FDA 1572s), patient files and    |
|               |     other non-computerized documents.                |
|               |                                                      |
|               | -   Receive, collate and archive all materials       |
|               |     required for fulfillment of contractual          |
|               |     obligations by COG or received from drug         |
|               |     companies involved.  Develop and execute quality |
|               |     assurance landmarks for such materials.  These   |
|               |     activities will include, but are not limited to, |
|               |     integration of data obtained from resource       |
|               |     laboratories into databases transferred to drug  |
|               |     companies when necessary.                        |
+---------------+------------------------------------------------------+
| SmithHanley   | -   Orchestrate the activities and deliverables of   |
|               |     all study conduct partners to ensure timely      |
|               |     delivery of quality data on one or more studies  |
|               |                                                      |
|               | -   Oversee Site Management Organizations to ensure  |
|               |     that protocol and Monitoring Plan is             |
|               |     consistently and appropriately implemented       |
|               |     across investigator sites and countries.         |
|               |                                                      |
|               | -   Proactively identify and resolve study           |
|               |     operations-related issues as they arise.         |
|               |                                                      |
|               | -   Responsible for ensuring that the operational    |
|               |     aspects of a clinical study meet time, quality & |
|               |     cost targets.                                    |
|               |                                                      |
|               | -   Responsible for ensuring that studies are        |
|               |     conducted in compliance with GCP, relevant SOPs, |
|               |     and regulatory requirements; Responsible for     |
|               |     inspection readiness for all aspects of the      |
|               |     study conduct.                                   |
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Clinical Data Manager

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| ARS           | 1\. Work with database programmers to setup          |
|               | databases.                                           |
|               |                                                      |
|               | 2\. Oversee the creation of data management study    |
|               | documentation.                                       |
|               |                                                      |
|               | 3\. Review case report forms and create data         |
|               | correction forms.                                    |
|               |                                                      |
|               | 4\. Work with CRA\'s and monitors to resolve data    |
|               | discrepancies.                                       |
|               |                                                      |
|               | 5\. Participate in the development of department     |
|               | SOP\'s.                                              |
|               |                                                      |
|               | 6\. Provide leadership to junior data managers.      |
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| SmithHanley   | -   provide timely and professional ongoing quality  |
|               |     management of clinical trial data by identifying |
|               |     errors/inconsistencies in CRF data and ensuring  |
|               |     their resolutions in order that databases can be |
|               |     declared clean and locked according to strict    |
|               |     performance standards.                           |
|               |                                                      |
|               | -   Review and contribute to the development of      |
|               |     trial validation plan related documents and      |
|               |     create/approve final CRF design, validation      |
|               |     checks and reports necessary to assure high      |
|               |     quality and consistent data.                     |
|               |                                                      |
|               | -   Review and contribute to the preparation of      |
|               |     protocols, CRF\'s and prepare or                 |
|               |     review/contribute to operations manuals.         |
|               |                                                      |
|               | -   Support and assist clinical data managers,       |
|               |     clinical data assistants for allocated trials.   |
+---------------+------------------------------------------------------+
| SmithHanley   | -   Set up the clinical trial database for assigned  |
|               |     projects as per SOPs and Dept. and/or Sponsor    |
|               |     conventions.                                     |
|               |                                                      |
|               | -   Validate the completeness, accuracy and          |
|               |     consistency of the clinical trial database on an |
|               |     ongoing basis.                                   |
|               |                                                      |
|               | -   Develop and maintain the Data Management Plan    |
|               |     (DMP), the Data Handling Conventions Document,   |
|               |     the Self-Evident Corrections Document, the Edit  |
|               |     Check Document and various other project         |
|               |     specific documentation.                          |
|               |                                                      |
|               | -   Perform the day-to-day Data Management function  |
|               |     on all assigned projects conducted in            |
|               |     conjunction with the Clinical Project Team.      |
|               |                                                      |
|               | -   Perform in-house data management review of the   |
|               |     CRFs for database and query validation, and      |
|               |     related project specific requirements, and       |
|               |     document/address any errors, etc. found during   |
|               |     review.                                          |
|               |                                                      |
|               | -   Work with the Clinical Data Programmer (CDP) to  |
|               |     develop, test and validate all project specific  |
|               |     programming (i.e.. Edit Check Programs, Tables   |
|               |     and Listing programs, CRF Tracking reports,      |
|               |     database status reports, and any ad hoc          |
|               |     programming requests).                           |
|               |                                                      |
|               | -   Produce automated and manual data queries or     |
|               |     Data Clarification Forms (DCFs), review the      |
|               |     queries for correctness, and provide the DCFs to |
|               |     Project Management for subsequent resolution     |
|               |     with the study site.                             |
|               |                                                      |
|               | -   Track and administer all project related         |
|               |     queries/DCFs as related to the project database. |
|               |                                                      |
|               | -   Make appropriate updates to the clinical trial   |
|               |     database (CTDB) to correct any erroneous data    |
|               |     that is identified during the data entry, data   |
|               |     review, process data query (DCF or DRF) and/ or  |
|               |     data reporting processes.                        |
|               |                                                      |
|               | -   Apply corrections and/or updates that are        |
|               |     identified through query resolution or other     |
|               |     sources to the appropriate documents (working    |
|               |     copies, etc.). Maintains necessary documentation |
|               |     of all updates to the CTDB.                      |
|               |                                                      |
|               | -   Perform the QC audit of the CTDB prior to        |
|               |     database lock, and make appropriate changes as   |
|               |     per findings, SOPs and Departmental Procedures.  |
|               |                                                      |
|               | -   Document errors, omissions, and inconsistencies  |
|               |     found during the database validation or QC audit |
|               |     process.                                         |
|               |                                                      |
|               | -   Organize and maintain documentation for quality  |
|               |     and audit processes, as well as that supporting  |
|               |     the accuracy of the CTDB.                        |
|               |                                                      |
|               | -   Work with Internal/Sponsor\'s Data Management,   |
|               |     Safety, Biostatistics, Project Team personnel    |
|               |     for assigned projects.                           |
|               |                                                      |
|               | -   Work with Project Team Members to complete the   |
|               |     study and lock the CTDB as per agreed upon       |
|               |     timelines and in accordance with all applicable  |
|               |     SOPs and Departmental Procedures.                |
|               |                                                      |
|               | -   Generate and/or review listings to check the     |
|               |     accuracy and completeness of clinical data       |
|               |     coding.                                          |
+---------------+------------------------------------------------------+
| CoreTech      | -   Work with internal database developers to set-up |
|               |     database and edit checks                         |
|               |                                                      |
|               | -   Coordinate/review Clinical Data Management       |
|               |     documents such as Clinical Data Management       |
|               |     plans, data handling conventions, coding         |
|               |     conventions, CRFs, CRF completion guidelines,    |
|               |     data review guidelines, and clean-file           |
|               |     documentation according to local and global      |
|               |     SOPs;                                            |
|               |                                                      |
|               | -   Conduct database QC checks                       |
|               |                                                      |
|               | -   Conduct/ensure CRF archival for all data in the  |
|               |     database; Ensure CRFs are tracked from receipt   |
|               |     to the archival; Oversee data reviews and        |
|               |     conduct/ensure query generation/resolution       |
|               |                                                      |
|               | -   Ensure accurate maintenance of study files       |
|               |                                                      |
|               | -   Participates in activities to ensure             |
|               |     quality/completeness of clinical trial data      |
|               |                                                      |
|               | -   Monitor progress of Clinical Data Management     |
|               |     activities for a trial                           |
|               |                                                      |
|               | -   Execute trial set-up activities, query           |
|               |     generation/resolution, data coding and database  |
|               |     QC                                               |
|               |                                                      |
|               | -   Participate in protocol and CRF reviews          |
|               |                                                      |
|               | -   Annotate CRFs with database specifications in    |
|               |     accordance with global and local standards       |
|               |                                                      |
|               | -   Coordinate database design, database validation  |
|               |     and approval                                     |
|               |                                                      |
|               | -   Update and review databases                      |
|               |                                                      |
|               | -   Coordinate production/execution of validation    |
|               |     guidelines and other study documentation in      |
|               |     accordance with project standards                |
|               |                                                      |
|               | -   Design data collection tools and coordinate the  |
|               |     validation approval                              |
|               |                                                      |
|               | -   Create clinically appropriate edit               |
|               |     specifications                                   |
|               |                                                      |
|               | -   Examine/review clinical trial documents          |
|               |                                                      |
|               | -   Generate and resolve data queries                |
|               |                                                      |
|               | -   Perform final query resolution and closure of    |
|               |     archives for close-out reporting and             |
|               |     publications                                     |
|               |                                                      |
|               | -   Execute edit integration/query integration       |
|               |                                                      |
|               | -   Ensure CRFs exist and are archived for all data  |
|               |     in the database                                  |
|               |                                                      |
|               | -   Coordinate/execute database lock                 |
|               |                                                      |
|               | -   Coordinate safety database reconciliation        |
|               |                                                      |
|               | -   Review Statistical Analysis Plan to ensure data  |
|               |     collection supports endpoint analysis            |
|               |                                                      |
|               | -   Review tables and listings                       |
|               |                                                      |
|               | -   Review Clinical Study Reports, publications,     |
|               |     submission                                       |
|               |                                                      |
|               | -   Ensure compliance of systems associated with a   |
|               |     project                                          |
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