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Clinical Research Coordinator I

PMG Research, Inc


Location:
Wilmington, North Carolina
Date:
03/27/2018
2018-03-272018-04-26
Job Type:
Employee
Categories:
  • Clinical Operations
PMG Research, Inc
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Job Details

Summary/Objective:

The position is accountable for completing clinical trial assignments in an accurate and timely manner in accordance with the SOP’s, COG’s, and ICH guidelines.

Essential Functions:

Ensures the safety of our volunteers. Promotes the mission of PMG to function as an Integrated Site Network. Consistently strives to meet and exceed priorities as discussed with direct supervisor. Actively recruiting and promoting our service to suitable participants and sponsor representatives. Performing tasks required to coordinate and complete a study according to the protocol and maintaining communication with the Manager of Clinical Operations regarding training, orientation, or other concerns regarding the coordination of clinical trials.

Specific Responsibilities:

  • Develop and maintains proper skills to comply with the protocol, federal regulatory requirements, internal SOP’s, and COG’s
  • Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
  • Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
  • Communicates with the Manager of Clinical Operations regarding training/orientation, recruitment efforts, the overall status of a trial(s), and other concerns.
  • Attends investigator meetings.
  • Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines.
  • Accurately collects study data via source documents/progress notes as required by the protocol.
  • Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.
  • Performs continuous reviews of the inclusion and exclusion criteria for each participant during the screening period.
  • Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.
  • Builds strong relationships with Investigators and provides ongoing communication about trial status and participants.
  • Dispenses study medication at the direction of the Investigator.
  • Maintains communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits.
  • Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor.
  • Addresses all queries or data clarifications within 48 hours of receipt.
  • Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in timely manner during these visits.
  • Reports protocol violations and significant deviations to the Manager of Clinical Operations.
  • Establishes relationships with volunteers, and participates in patient education regarding the clinical trial process and provides specific trial information to the participant as well as conducting the informed consent process.
  • Assists other staff members as determined by the needs and priorities of the research organization and as time and abilities permit.
  • Anticipates possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement.
  • Prepares study documentation in the event of a PMG, sponsor, or FDA audit and assists the auditor for the duration of the audit including correcting discrepancies in a timely manner.

Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands: This position requires physical effort. Incumbent must be able to lift and carry up to 30 pounds. This position does involve direct contact with patients and includes performing phlebotomy procedures as needed. Occupational Health and Safety Risks include potential exposure to bloodborne and airborne pathogens. CRC Level I’s should be certified or working towards certification in cardiopulmonary resuscitation.

Position Type/Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m.

Travel: This position may involve limited travel, including airplane and car travel, to attend investigator meetings and ongoing training opportunities.

Required Education and Experience: LPN, Certified Nursing Assistant, Certified Medical Assistant, or 4 year degree or equivalent preferably within Biology, Pharmacology, or a health-related field of study. Some hands-on experience in the medical field is expected such as internships, practicum’s, or prior work experience.

Additional Eligibility Qualifications: Must be able to utilize computer-based applications such as Microsoft Office or other web based systems or have a willingness to learn the applications.Must have superior interpersonal and communication skills to facilitate interactions with patient participants and sponsor representatives.

Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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