Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
1) Comply with all company policies, procedures, and conduct.
2) Strictly adhere to confidentiality and compliance standards.
3) Communicate effectively and courteously with study patients regarding study objectives and ongoing instructions.
4) Administer questionnaires and monitor participant compliance.
5) Acknowledge study patients' needs and tends to them appropriately.
6) Collect patient medical history and conditions.
7) Obtain Informed Consent.
8) Study drug dispensation records, accountability.
9) Liaison with laboratories to ensure timely participant testing
10) Collect and evaluate concomitant medication.
11) Collect and evaluate medical records for compliance.
12) Conduct A/E and SAE assessments.
13) Perform EKG, vital signs, nasal swabs and protocol specific procedures.
14) Evaluate clinical lab reports.
15) Maintain office site regulatory files.
16) Verify accuracy of data collected.
17) Document temperatures for IP stored on-site.
18) Assist with the recruitment and engagement of study subjects as needed.
19) Develop study e-source documents to comply with study protocol.
20) Manage all required study startup documentation, training, and timelines on assigned study protocols.
21) Meet all study protocol requirements and deadlines.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE:
1) Associate’s degree in healthcare or related field, preferred.
2) 2 years’ experience in healthcare, required.
3) 2 years’ experience in FDA regulations and GCP.
4) 1 year experience in phlebotomy and EKG, required.
5) Proven track record of analytic reasoning skills.
6) Exceptional attention to details and organization.
7) Must possess excellent verbal and written communication skills.
8) Excellent customer service skills with internal and external stakeholders.
9) A proven ability to multi-task in a rapidly changing environment.
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