WinstonSalemRecruiter Since 2001
the smart solution for Winston-Salem jobs

Lead Clinical Research Coordinator

Company: Piedmont Ear Nose and Throat Associates, PA
Location: Winston Salem
Posted on: April 9, 2021

Job Description:

Job Summary:Responsible for the overall leadership and direction of all clinical research operations including but not limited to fiscal management, study and site operations, regulatory processes and patient recruitment. The Lead Clinical Research Coordinator is responsible for developing growth strategies, and managing and/or coordinating clinical studies. Essential Functions:

  • Promote business growth with PENTA Investigators and increase visibility within the Pharmaceutical Industry. Ensure subject safety across all trials.
  • Assess clinical trials in terms of study's impact on site resources, labor cost, cost by procedure and practice suitability. Complete site feasibilities, facilitate sponsor pre-site visits and secure clinical trials for the PENTA research department.
  • Coordinate Phase I through Phase IV clinical pharmaceutical trials. Duties include obtaining suitable patients who meet all admission criteria, assisting with patient education, adhering to the study protocol and maintaining proper documentation according to the protocol and regulatory requirements. Documenting laboratory data and adverse reaction, correcting discrepancies, anticipating possible problems and resolutions, maintain communication with the monitor from the sponsoring company, and performing technical requirements of the protocol which included phlebotomy.
  • Develop and implement the marketing plan for PENTA research as well as the recruitment plan for each enrolling study. Monitor subject accrual rates and implement action plans for accrual issues.
  • Complete all IRB documents to obtain regulatory approval. Manage annual reports to the IRB. Document protocol deviations and report to the IRB as required.
  • Develop the budget for each study and perform negotiations with study sponsors. Invoice sponsors as required and prepare the allocation spreadsheet for each check. Manage research expenses. Review and approve study contracts.
  • Develop and revise the PENTA research SOP's. Ensure research staff adherence to SOP's and all federal requirements.
  • Train and supervise support staff ensuring adherence to protocol and regulatory requirements.
  • Manage special projects and other research initiatives as assigned.Minimum Requirements:
  • Relevant degree (e.g., Bachelor's degree in a relevant discipline such as Health Administration, Nursing, or Business) or equivalent combination of experience and education (certification CCRC).
  • At least 5 years' experience pharmaceutical research experience including previous supervisory experience. Key Competencies:
  • Knowledge of ICH GCP, CFR guidelines and industry requirements.
  • Clinical knowledge to perform clinical duties. (Phlebotomy, ECG's)
  • IATA certification-knowledge in specimen processing and shipment
  • Oral/written communication skills
  • Interpersonal skills
  • People management (supervision)
  • Problem solving skills
  • Computer skills
  • Detail Oriented
  • Customer Service Oriented PI133193793

Keywords: Piedmont Ear Nose and Throat Associates, PA, Winston-Salem , Lead Clinical Research Coordinator, Healthcare , Winston Salem, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Healthcare Jobs

Description: Source Medical Staffing believes that making a difference matters. We come to work every day to make a difference,
Company: Source Medical Staffing, LLC
Location: Danville
Posted on: 04/19/2021

Bariatric Surgeon Needed in Danville, VA Part-Time - $120K - $220K / Year + Benefits
Description: Bariatric Medicine opening in Danville, Virginia. This and other physician jobs brought to you by Bariatric Surgeons Needed for Full- and Part-Time Careers with Fast Growing Post-Acute Care (more...)
Company: Vohra Wound Physicians
Location: Danville
Posted on: 04/19/2021

Endoscopy Nurse - Travel - (Endo RN)
Description: Job Description RequirementsEndoscopy Nurse - Endo RN StartDate: 05/10/2021Available Shifts: 8 D/E Pay Rate: 1426.21 - 1571.75For more than 130 years, Sovah Health - Danville has been part of the (more...)
Company: American Mobile Healthcare
Location: Danville
Posted on: 04/19/2021

Med/Surg - Registered Nurse -RN
Description: Why CrossMed - - CrossMed was created by a group of women who wanted to help people within the Healthcare space. - In a market saturated with big companies and even bigger overhead we want to remain (more...)
Company: CrossMed Healthcare
Location: Danville
Posted on: 04/19/2021

Travel Registered Nurse RN Endoscopy GI Lab
Description: Endoscopy Nurses -include interviewing patients to obtain medical information measuring patients' vital signs, weight, and height and administering
Company: OneStaff Medical
Location: Danville
Posted on: 04/19/2021

Travel Nurse RN - Progressive Care Unit - $1,400 per week
Description: OneStaff Medical is seeking a travel nurse RN Progressive Care Unit for a travel nursing job in Danville, Virginia.Job Description Requirements ul li Specialty: Progressive Care Unit li Discipline: (more...)
Company: NurseFly
Location: Danville
Posted on: 04/19/2021

Hyperbaric Medicine Physician Job in Danville, VA
Description: Hyperbaric opening in Danville, Virginia. This and other physician jobs brought to you by DirectShifts is seeking a Hyperbaric Medicine Physicians to work in Danville, VA . This is a Full (more...)
Company: DirectShifts
Location: Danville
Posted on: 04/19/2021

Family Medicine position in VA (Physician #)
Description: FM Residency Program in Virginia seeking core faculty member Located in Danville, VA - just 47 miles from Greensboro, NC Service area of 127,000 people Full-time, permanent opening (more...)
Company: Archway Physician Recruitment
Location: Danville
Posted on: 04/19/2021

RN - Registered Nurse - Endoscopy
Description: Gastroenterology opening in Danville, Virginia. This and other rn jobs brought to you by Client in VA seeking Endoscopy Registered Nurse RN to work DAY Located midway between New (more...)
Company: CoreMedical Group
Location: Danville
Posted on: 04/19/2021

Registered Nurse (RN) - Oncology (ONC)
Description: Oncology opening in Danville, Virginia. This and other rn jobs brought to you by Adventure Awaits Accountable is leading the way in Travel Nursing - Run by Nurses for Nurses, we Care (more...)
Company: Accountable Healthcare Staffing
Location: Danville
Posted on: 04/19/2021

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Winston-Salem RSS job feeds