Study coordinator (m/f) Job in Anderlecht 1700, Brussels Belgium

 

 

XPE Pharma is looking to hire a study coordinator (m/f) for one of its clients, a Pharmaceutical company situated in Andederlecht (Belgium).

 

GENERAL DESCRIPTION

 

We are looking for a study coordinator that will conduct the clinical study and this for a limited period.

 

KEY RESPONSIBILITIES ACCOUNTABILITIES

 

Your overall responsibilities:

 

· Responsible for participating in ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, within regulatory requirements/guidelines, and Pfizer SOPs

· Responsible for volunteer safety

· Responsible for study activities including assessment of physiologic response to drug administration, administration of variable formulations of study medications including but not limited to delivery by oral, IV, IM, transdermal, and pulmonary routes

· Responsible for cardiac monitoring, basic nursing care and emergency interventions

· Responsible for the collection and documentation of electronic and written data

· Responsible for recording study data, maintaining source documentation, and updating volunteer database specific to study participation

· Assist in the conduct of clinical trials in the CRU

 

Your primary responsibilities:

· Participate as a member of clinic study team to execute clinical research protocols

· Initiation and monitoring of assigned study activity for clinical research protocols, as appropriate

· With supervision, create Informed Consent Documents for assigned protocols, as appropriate

· Review and provide input, to designated clinic team contact, on assigned synopses, protocols and ICDs

· Document individual subject’s participation while involved in study activities

· Create and detail study activity documents for volunteer use, as appropriate

· Administer study medication in accordance with protocol

· Evaluate adverse events and intervene as appropriate

· Communicate protocol requirements to study subjects and facilitate compliance

· Maintain accuracy, accessibility, and confidentiality in volunteer records and reports

· Assist in the data management/cleaning activities for assigned protocols

· Facilitate positive attitude and trust by the volunteer population toward participation in clinical research

· Receive, respond, and resolve all queries specific to subject data collection

· Maintain competency to assist with implementation of general technical activities (collection and processing of human specimens and laboratory samples, vital signs and other physiological testing and measurements) and those study activities requiring emergency nursing intervention

· Serve as a lead nurse on a protocol, as appropriate

· Assist in writing end of study reports

 

Measures of accomplishment:

 

· Able to perform in teams to effectively collaborate to support study objectives as evidenced by 360 degree feedback

· Successful study conduct of CRU studies in accordance with ethical, legal, and moral standards, Good Clinical Practices, Good Laboratory Practices, CRU management requests, and PGRD drug development goals

· Contribute to the business needs through fulfillment of the essential functions specified in this role

· Evidence of positive relationships with CRU volunteers

· Demonstrate effective communication with CRU colleagues

· Nursing interventions are appropriate, immediate, and demonstrate excellent assessment skills and standards of care

· Provide study activity coverage

 

 

 

 

REQUIRED EDUCATION SKILLS

 

 

· Nursing degree

· Valid licensure

· Familiar and experience in clinical research

· Responsible for accurate interpretation and execution of research protocols.

· Must have the ability to participate as an effective team member in diverse workgroups to accomplish business objectives.

· Evaluate adverse events and intervene as appropriate.

· Maintain accuracy, accessibility, and confidentiality in volunteer records and reports.

· Represent the CRU on global initiatives as a subject matter expert, as appropriate

· Minimum of 1 year general medical-surgical nursing experience including competency in phlebotomy/venipuncture techniques, and performing electrocardiograms

· Superior written and verbal skills are essential; including the ability to communicate complicated research principles in easily understandable language.

· Must have the ability to function as an effective team member in diverse workgroups to accomplish business objectives.

· Must have a working knowledge of computers, medical conditions, research techniques, and the application of clinical research.

· Must be available for various shifts (weekends/evenings/nights)

· ACLS and BCLS certification

 

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