Clinical Research Regulatory Coordinator

Palmetto Primary Care Physicians Summerville, South Carolina
clinical research research regulatory coordinator regulatory research medical team regulations clinical research regulatory submissions compliance personnel
December 31, 2022
Palmetto Primary Care Physicians
Summerville, South Carolina
FULL_TIME

About Palmetto Primary Care Physicians

Palmetto Primary Care Physicians (PPCP) is the largest independent multi-specialty group practice in South Carolina. The group is comprised of over 100 clinical providers with a wide range of expertise in primary and specialty care including endocrinology, gastroenterology, neurology, psychiatry, audiology and physical therapy. The company employs over 500 clinical and non-clinical staff throughout South Carolina and provides exceptional medical care for patients through 34 physician’s offices in ten counties.

PPCP has proudly served patients since 1996 and is known for their innovative patient centered delivery model. The group was among one of the first practices to nationally establish a successful Patient Centered Medical Home Program and the first in South Carolina. Today PPCP offers a wide range of services, including a state-of-the-art urgent care clinic, imaging, diagnostics and labs.

To learn more about PPCP, visit www.PalmettoPrimaryCare.com

  • Offer 401K with generous company match
  • Medical, Dental, Vision Benefits
  • Short Term and Long Term Disability Offered

Job Summary:

To serve as clinical research regulatory coordinator during the conduct of clinical research trials at the investigative site. By performing the job descriptions below and other duties as assigned, you will be able to facilitate the research process by increasing productivity, decreasing costs, and decreasing the time of the approval process.

Job Functions:
Pre-Trial Information:

  • Submit application of interest and appropriate documentation to Sponsor.
  • Initiate Sponsor communication between Site and Sponsor Start-up Team for both domestic and multi-national trials.
  • Obtain Confidential Disclosure Agreement for all parties involved
  • Run patient query report within EMR system to ensure appropriate site feasibility for trial. Collaborate with Principal Investigator regarding potential trial to ensure feasibility.
  • Complete sponsor required feasibility questionnaire and documentation. Follow-up with Sponsor as needed regarding potential trial.
  • Communicate with Sponsor to set up Site Qualification Visit as required by Sponsor, IRB, and FDA.
  • Follow-up with Sponsor regarding Site’s approval to conduct potential trial.

Study Start-up:

  • Acquire study start-up documentation from Sponsor’s Start-up Team. Documents include, but are not limited to: FDA Form 1572, Financial Disclosure forms for all parties involved, Protocol Signature page, Investigator Brochure Signature Page, CV’s, applicable licenses, Good Clinical Practice certification, proper lab documentation, IRB submission application,
  • Review clinical and regulatory documents and regulatory submissions for data accuracy, consistency, formal quality and readability, resolving identified issues in collaboration with authors in a productive fashion
  • Stays in constant contact with Sponsor delegates to ensure submissions are received and submitted properly.
  • Schedules Investigator Meeting and/or Site Initiation Visit. Coordinates site staffs’ schedules to guarantee training and compliance through attendance.

During Trial:

  • Ensures all appropriate site personnel are trained and delegated for the trial.
  • Confirms training and delegation are documented appropriately as required by Sponsor, IRB, and FDA.
  • Makes sure site personnel have completed all Sponsor required training, both on paper and electronic. And that all site members have turned in certifications and/or site documentation.
  • Prepares, reviews and submits regulatory submissions, including INDs, Protocol and signature pages, Investigator’s Brochures and signature pages, Safety Reports, and other regulatory documents in both paper and electronic format.
  • Coordinates the preparation of regulatory documents for submission to the Institutional Review Board (IRB), other internal committees, and the FDA as necessary including but not limited to: Initial documents submission; Continuing Reports; Amendments and addendums to research protocols and consent documents and Adverse Event reporting. Collaborates with study team members to perform these duties.
  • Assist in preparing regulatory submissions and maintaining the regulatory files.
  • Communicates with sponsor who conducts trial registration and disclosure activities - supports all activities that ensure that company is in compliance with applicable laws and regulations
  • Manages and executes all aspect of and all types of submission/ePublishing projects working across multiple sponsors and therapeutic areas at the Research Site
  • Ensuring compliance with FDA and other regulatory agency regulations.
  • Prepare and submit Continuing reports at appropriate time frames as required by IRB
  • Maintains communication with IRB
  • Responsible for collaborating with the Principal Investigators, Sub-Investigators, Clinical Research Coordinators, and Sr. Managers with all aspects of clinical trial regulatory submission and compliance.
  • Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.
  • Collaborates with Sponsor’s delegate and Site team members to schedule and conduct Interim Monitoring Visits
  • Prepares all regulatory documents for Interim Monitoring Visits

Study Close-out:

  • Collaborates with Sponsor’s delegate and Site team members to schedule site close-out visit
  • Completes Regulatory Documentation for Site Closeout visit
  • Ensures site is aware of Sponsor/FDA/IRB regulations of proper site close-out and storage of trial information per CFR part 21 guidelines.
  • Prepares IRB submission of Trial Close-out and notifies IRB when trial is closed
  • Prepare study summary and/or close-out letter for IRB.
  • Provide method of document retrieval from storage.

Site Information:

  • Ensure proper maintenance of GCP certificates for all site personnel
  • Updating site personnel CV’s, Medical Licenses, and Certifications
  • Maintaining updates on IATA training on appropriate site personnel
  • Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
  • Answer incoming calls and directing appropriate locations
  • Remind patients of scheduled appointments
  • Order office supplies
  • Outside Advertisement (electronic and print advertising)

Knowledge:

  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Review product promotional materials for compliance with applicable regulations and policies.
  • Write or update standard operating procedures or policies.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of regulatory documentation databases or systems.
  • Determine the types of regulatory submissions or internal documentation that are required.
  • Participate in internal or external audits.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Prepare responses to Sponsor/IRB/FDA requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.

Skills:

  • Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time; both internally and externally.
  • Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.
  • Communicating with Persons outside organization - Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
  • Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic form.
  • Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
  • Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.
  • Consistently demonstrate ability to respond to changing situations in a flexible manner in order to meet current needs, such as reprioritizing work as necessary.
  • Minimize non-productive time and fill slow periods with activities that will enable you to prepare to meet the future needs of the System (education, organizing, housekeeping, and assisting others). Organize job functions and work area to be able to effectively complete varied assignments within established time frames
  • Maintains a cooperative relationship among health care teams by communication information; responding to requests; building rapport; participating in team problem-solving methods.
  • Other duties as assigned.

Organizational Commitments:

  • Attend staff meetings.
  • Support other site personnel as necessary.
  • Follow administrative procedures.

Position Qualifications:

  • Knowledge of Medical Terminology
  • EDC experience preferred
  • Familiarity with chart review and tracking data from charts
  • Attention to detail
  • Ability to work effectively with wide range of individuals and groups at all levels of authority
  • Excellent interpersonal, oral, and written communication skills are essential.
  • Strong critical thinking and problem solving are required.
  • Prior work with clinical research or patient care preferred.
  • Must have a strong work ethic, be proactive in identifying tasks that need to be completed
  • Strive for accuracy and quality when completing assignments.
  • Excellent computer skills to include strong knowledge of software (Microsoft Office Suite).

Education/Experience:

  • High School Diploma/GED (required)
  • 1-year clinical research or medical office experience (required)

Job Type: Full Time

Location: Summerville, SC

EOE

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

Education:

  • High school or equivalent (Required)

Experience:

  • clinical research or medical office: 1 year (Required)

Work Location: One location


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