Study Coordinator

Level 1

STUDY COORDINATOR LEVEL 1   

OVERVIEW

The study coordinator assumes respon­sibility for the complete coordination of onsite studies to ensure compliance with protocols and overall study objectives.

MAJOR DUTIES AND RESPONSIBILITIES

STUDY INITIATION

  • Recruitment of study subjects by completing all required pre-screening and screening for each study.
  • Review all protocols and maintain full knowledge and understanding of the requirements per the sponsor/CRO
  • Partner with the primary investigator and sub-investigator(s) as appropriate for each protocol and notify the Site Manager of any problems or serious issues that may arise.
  • Establish and maintain the Regulatory Binder per FDA, sponsor, and CRs standards under the supervision of the Site Manager.
  • Document the receipt of all study supplies, including the study drug, CRFs, lab supplies, letter of indemnification, IRB information, etc.
  • Arrange for storage of investigational drugs per FDA and sponsor requirements in a locked, secure, and limited-access area.
  • Maintain confidentiality for all protected health information as required by federal guidelines (HIPPA)
  • Properly obtain and document the Informed Consent process on all study subjects and be sure the subject has a signed copy of the Informed Consent document prior to any protocol procedures being conducted.
  • Discuss appropriate protocol requirements with all ancillary services involved and solicit studies support
  • Schedule study subject appointments with physicians, lab, x-ray, etc., in accordance with protocol re­quirements

ONGOING STUDY CONDUCT

  • Establish and maintain appropriate forms for each study subject including consent forms, case report forms, drug accountability records, diaries, extra visit procedure forms, etc
  • Dispense and account for study drugs in accordance with the protocol under the direction of the investigator and log information to the study drug accountability form
  • Enter subject visit information to Clinical Conductor and EDC in a timely manner
  • Inform appropriate QA, IRB, and Sponsor/CRO personnel of any deviations or violations from the protocol
  • Participate in internal or external monitoring visits and resolve any issues in a timely manner
  • Communicate and encourage a high level of awareness and interest in all research projects among clinic physicians and staff

STUDY CLOSINGS

  • Ensure final Sign off of e-CRF’s is received in a timely manner
  • Return or dispose of unused study supplies and medications per CRS SOP and/or sponsor instructions
  • Review regulatory binder for completion.  Completion of the IRB closeout report and review of all reported deviations for appropriate documentation. Forward all material to support the closing of a study by returning all supply invoice(s), extra visit procedures etc., as required by the sponsor
  • Store site copies of CRF, the regulatory binder, and all other pertinent study-related material in a secured area until notified by the sponsor/CRO regarding proper disposition
  • Facilitate audits by the sponsor, FDA, or other regulatory agencies as appropriate by providing all pertinent study-related records and be available for clarification

GENERAL

  • Maintain working knowledge of pertinent FDA regulations
  • Assist in any study-related function as needed
  • Fully participate with all monitoring visits; resolving issues with the monitor while on-site when possible.
  • Maintaining a working knowledge of Clinical Conductor
  • Responsible for on-call rotation (personally being on-call for assigned rotation time frame)
  • Other tasks assigned by the direct supervisor including, but not limited to management of internal trials.

SUPERVISORY RESPONSIBILITY:

This position has no supervisory responsibilities.

WORK ENVIRONMENT:

Mixture of Clinical and Office environment where you would be sitting at a desk working/typing on a computer approximately 50% of the time and with patients and in the lab on your feet 50% of the time.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  While performing the duties of this job, the employee is regularly required to communicate, converse with, and exchange information. The employee is frequently required to be in stationary position at least 50% of the time; use hands and fingers to grab; and reach with hands and arms.

The Employee is occasionally required to run; traverse; and stoop, kneel, crouch or crawl. The employee may occasionally lift or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

  • This position requires some travel for off-site meetings up to 20%. Some trips could include overnight stay for investigator and/or management meetings.

COMPETENCIES

  • Strong communication and organizational skills
  • Proven time management and motivation skills
  • Flexible and ability to work with multiple deadlines and priorities
  • Team player who can also effectively work independently
  • Take initiative by anticipating and eliminating potential barriers
  • Solution-oriented and problem-solving attitude.  Focused on improving current processes for better efficiency and faster turn-around
  • Ability to communicate and work with people at multiple levels (site, clinic, management, sponsor, CRO, etc.)

EDUCATION AND KNOWLEDGE REQUIREMENTS

  • Some college or college degree preferred (or equivalent and relevant experience)
  • Knowledge of ICH GCP guidelines
  • Possess computer skills, intermediate experience with MS Office
Level 2

STUDY COORDINATOR LEVEL 2

OVERVIEW

The Study Coordinator must have worked in the field 2 years and obtained their CCRC certificate. They have working knowledge of GCP and ICH guidelines. They assume respon­sibility for the complete coordination of onsite studies to ensure compliance with protocols and overall study objectives and goals.

MAJOR DUTIES AND RESPONSIBILITIES

STUDY INITIATION

  • Recruitment of study subjects by completing all required pre-screening and screening for each study.
  • Review all protocols and maintain full knowledge and understanding of the requirements per the sponsor/CRO
  • Partner and goal plan with the primary investigator and sub-investigator(s) as appropriate for each protocol and notify the Site Manager of any problems or serious issues that may arise.
  • Establish and maintain the Regulatory Binder per FDA, sponsor, and CRs standards under the supervision of the Site Manager.
  • Document the receipt of all study supplies, including: the study drug, CRFs, lab supplies, letter of indemnification, IRB information, etc.
  • Arrange for storage of investigational drugs per FDA and sponsor requirement in a locked, secure, and limited-access area.
  • Maintain confidentiality for all protected health information as required by federal guidelines (HIPPA)
  • Properly obtain and document Informed Consent process on all study subjects and be sure subject has a signed copy of Informed Consent document prior to any protocol procedures being conducted.
  • Discuss appropriate protocol requirements with all ancillary services involved and solicit studies support
  • Schedule study subject appointments with physicians, lab, x-ray, etc., in accordance with protocol re­quirements

ONGOING STUDY CONDUCT

  • Establish and maintain appropriate forms for each study subject including consent forms, case report forms, drug accountability records, diaries, extra visit procedure forms, etc
  • Dispense and account for study drugs in accordance with the protocol under the direction of the investigator and log information to the study drug accountability form
  • Enter subject visit information to Clinical Conductor and EDC in a timely manner
  • Inform appropriate QA, IRB, and Sponsor/CRO personnel of any deviations or violations from the protocol
  • Participate in internal or external monitoring visits and resolve any issues in timely manner
  • Communicate and encourage a high level of awareness and interest in all research projects among clinic physicians and staff.
  • To meet and exceed goals on their projects.

STUDY CLOSINGS

  • Ensure final Sign off of e-CRF’s is received in a timely manner
  • Return or dispose of unused study supplies and medications per CRS SOP and/or sponsor instructions
  • Review regulatory binder for completion.  Completion of the IRB closeout report and review all reported deviations for appropriate documentation. Forward all material to support the closing of a study by returning all supply invoice(s), extra visit procedures etc., as required by the sponsor
  • Store site copies of CRF, the regulatory binder and all other pertinent study-related material in a secured area until notified by the sponsor/CRO regarding proper disposition
  • Facilitate audits by the sponsor, FDA, or other regulatory agencies as appropriate by providing all pertinent study-related records and be available for clarification

GENERAL

  • Maintain working knowledge of pertinent FDA regulations
  • Assist in any study-related function as needed
  • Fully participate with all monitoring visits; resolving issues with monitor while on site when possible.
  • Maintaining working knowledge of Clinical Conductor
  • Goal planning for clinical trials.
  • Responsible for on-call rotation (personally being on-call for assigned rotation time frame)
  • Other tasks assigned by direct supervisor to include, but not limited to management of internal trials.

SUPERVISORY RESPONSIBILITY:

This position has no supervisory responsibilities.

WORK ENVIRONMENT:

Mixture of Clinical and Office environment where you would be sitting at a desk working/typing on a computer approximately 50% of the time and with patients and in the lab on your feet 50% of the time.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  While performing the duties of this job, the employee is regularly required to communicate, converse with, and exchange information. The employee is frequently required to be in stationary position at least 50% of the time; use hands and fingers to grab; and reach with hands and arms.

The Employee is occasionally required to run; traverse; and stoop, kneel, crouch or crawl. The employee may occasionally lift or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

  • This position requires some travel for off-site meetings up to 20%. Some trips could include overnight stay for investigator and/or management meetings.

COMPETENCIES

  • Strong communication and organizational skills
  • Proven time management and motivation skills
  • Flexible and ability to work with multiple deadlines and priorities
  • Team player who can also effectively work independently
  • Take initiative by anticipating and eliminating potential barriers
  • Solution-oriented and problem-solving attitude.  Focused on improving current processes for better efficiency and faster turn-around
  • Ability to communicate and work with people at multiple levels (site, clinic, management, sponsor, CRO, etc.)

EDUCATION AND KNOWLEDGE REQUIREMENTS

  • Some college or college degree preferred (or equivalent and relevant experience)
  • Must have a CCRC certification
  • Prior clinical trial operations experience across various therapeutic areas preferred
  • Knowledge of ICH GCP guidelines
  • Possess computer skills, intermediate experience with MS Office
Level 3

STUDY COORDINATOR LEVEL 3   

OVERVIEW

The Clinical Research Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with Sponsor approved protocols. They oversee, implement & coordinate the conduct of daily activities of the research studies and assistants. The study coordinator level 3 participates in the feasibility process and contributes to planning of goals to meet study requirements; assists with preparation and submission to the IRB and study start up.

MAJOR DUTIES AND RESPONSIBILITIES

STUDY INITIATION

  • Recruitment of study subjects by completing all required pre-screening and screening for each study.
  • Review all protocols and maintain full knowledge and understanding of the requirements per the sponsor/CRO
  • Partner with the primary investigator and sub-investigator(s) as appropriate for each protocol and notify Site Manager of any problems or serious issues that may arise.
  • Document the receipt of all study supplies, including: the study drug, CRFs, lab supplies, letter of indemnification, IRB information, etc.
  • Arrange for storage of investigational drugs per FDA and sponsor requirement in a locked, secure, and limited-access area.
  • Maintain confidentiality for all protected health information as required by federal guidelines (HIPPA)
  • Properly obtain and document Informed Consent process on all study subjects and be sure subject has a signed copy of Informed Consent document prior to any protocol procedures being conducted.
  • Discuss appropriate protocol requirements with all ancillary services involved and solicit studies support
  • Schedule study subject appointments with physicians, lab, x-ray, etc., in accordance with protocol re­quirements

ONGOING STUDY CONDUCT

  • Establish and maintain appropriate forms for each study subject including consent forms, case report forms, drug accountability records, diaries, extra visit procedure forms, etc.
  • Dispense and account for study drugs in accordance with the protocol under the direction of the investigator and log information to the study drug accountability form.
  • Inform appropriate QA, IRB, and Sponsor/CRO personnel of any deviations or violations from the protocol
  • Participate in internal or external monitoring visits and resolve any issues in timely manner
  • Communicate and encourage a high level of awareness and interest in all research projects among clinic physicians and staff

STUDY CLOSINGS

  • Ensure final Sign off e-CRF’s is received in a timely manner
  • Return or dispose of unused study supplies and medications per CRS SOP and/or sponsor instructions
  • Review regulatory binder for completion.  Completion of the IRB closeout report and review all reported deviations for appropriate documentation. Forward all material to support the closing of a study by returning all supply invoice(s), extra visit procedures etc., as required by the sponsor
  • Store site copies of CRF, the regulatory binder and all other pertinent study-related material in a secured area until notified by the sponsor/CRO regarding proper disposition
  • Facilitate audits by the sponsor, FDA, or other regulatory agencies as appropriate by providing all pertinent study-related records and be available for clarification

GENERAL

  • Maintain working knowledge of pertinent FDA regulations
  • Mentor Research Assistants and make sure they are reaching their goals.
  • Assist in any study-related function as needed
  • Fully participate with all monitoring visits, resolving issues with monitor while on site when possible.
  • Maintaining working knowledge of Clinical Conductor
  • Participate in budget calls
  • Participate in BTC calls and feasibilities
  • Responsible for on-call rotation (personally being on-call for assigned rotation time frame)
  • Other tasks assigned by direct supervisor to include, but not limited to management of internal trials.

SUPERVISORY RESPONSIBILITY:

This position has supervisory responsibilities.

WORK ENVIRONMENT:

Mixture of Clinical and Office environment where you would be sitting at a desk working/typing on a computer approximately 50% of the time and with patients and in the lab on your feet 50% of the time.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  While performing the duties of this job, the employee is regularly required to communicate, converse with, and exchange information. The employee is frequently required to be in stationary position at least 50% of the time; use hands and fingers to grab; and reach with hands and arms.

The Employee is occasionally required to run; traverse; and stoop, kneel, crouch or crawl. The employee may occasionally lift or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

  • This position requires some travel for off-site meetings up to 20%. Some trips could include overnight stay for investigator and/or management meetings.

COMPETENCIES

  • Strong communication and organizational skills
  • Proven Management skills
  • Flexible and ability to work with multiple deadlines and priorities
  • Team player who can also effectively work independently
  • Take initiative by anticipating and eliminating potential barriers
  • Solution-oriented and problem-solving attitude.  Focused on improving current processes for better efficiency and faster turn-around
  • Ability to communicate and work with people at multiple levels (site, clinic, management, sponsor, CRO, etc.)

EDUCATION AND KNOWLEDGE REQUIREMENTS

  • Some college or college degree preferred (or equivalent and relevant experience)
  • Prior clinical trial operations experience across various therapeutic areas preferred
  • Knowledge of ICH GCP guidelines
  • Must have their CCRC certificate
  • Possess computer skills, intermediate experience with MS Office

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