Non-IT

Clinical Research Coordinator – GI

Contract-to-Hire

Medasource

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Position: Clinical Research Coordinator

Location: Nationwide 1) Columbus, OH 2) Rockville, MD

Duration: 9-month contract-to-hire

Start Date: mid-June to July 1st

Job Description:

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director and Clinical Principal Investigator (PI). While the Director and Principal Investigator are primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the Director, PI and sponsor to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The Clinical Research Coordinator reports to the Director and the Principal Investigator. Daily activities are managed by the Clinical Research Manager

Responsibilities:

Conduct of Research

   Assists the Director and PI in study feasibility assessments as requested.

   Attends investigator meetings as required or requested by the Director or PI.

   Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

   Assists Director and PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.

   Works with the Regulatory Coordinator to ensure all documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.) are complete.

   Works with the Director and PI to develop and implement recruitment strategies in accordance with   RESEARCH and IRB requirements and approvals.

   Conducts or participates in the informed consent process including discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.

   Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

   Registers participants to the appropriate study site (if multi-location study).

   Registers each participant in the RealTime Clinical Trial Management System (CTMS) to ensure billing of study procedures to the appropriate funding source.

   Coordinates participant tests and procedures.

   Collects data as required by the protocol. Assures timely completion of Case Report Forms.

   Maintains study timelines.

   Reports all adverse and serious adverse events to Director, PI and sponsor within 24 hours of learning of the occurrence. 

   Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or  RESEARCH Policy on Investigational Drug/Device Accountability.

   Completes study documentation and maintains study files in accordance with sponsor requirements and  RESEARCH policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.

   Retains all study records in accordance with sponsor requirements and RESEARCH policies and procedures.

   Maintains effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study.

   Assists Director and PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations and  RESEARCH and sponsoring agency policies and procedures.

   Works with the Director and PI to manage the day to day activities of the study including problem solving, communication and protocol management.

 

Reporting

 

   Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research and other misconduct as described in the Code of Conduct to the Director and PI.

   Assists Director and PI with scientific and compliance reporting requirements in accordance with Federal regulations sponsoring agency policies and procedures. Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.

   Collects and reports ongoing patient recruitment/ enrollment metrics by study to Director and PI.

 

Project Closeout

   Assists the Director and Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, RESEARCH and the sponsoring agency in accordance with Federal regulations and sponsoring agency policies and procedures.

   Arranges secure storage of study documents that will be maintained according to Good Clinical Practice (GCP) guidelines or for the contracted length of time, whichever is longer.

 

Minimum Qualifications:

         Bachelor’s degree in clinical or scientific field

         Been part of a phase II / phase III sponsored clinical trial (min. 3 years)

         Experience with feasibility questionnaires

         Able to build out regulatory submissions and packets

         Phlebotomy experience

         Proficient in EKG

         SOCRA / ACRP certified is a plus

         CTMS systems is a plus

         GI/IBD experience a plus

Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

JO-2104-110366

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