Assistant Clinical Research Coordinator II

Job Description

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) Assist CRC team as requested to facilitate research and business needs,

4) Communicate effectively and courteously with study patients regarding study objectives and ongoing instructions.

5) Administer questionnaires and monitor participant compliance.

6) Acknowledge study patients' needs and tends to them appropriately.

7) Collect patient medical history and conditions.

8) Obtain Informed Consent.

9) Liaison with laboratories to ensure timely participant testing.

10) Collect and evaluate concomitant medication.

11) Collect and evaluate medical records for compliance.

12) Perform study procedures such as EKG, vital signs, nasal swabs, and protocol specific procedures.

13) Verify accuracy of data collected.

14) Perform administrative tasks such as ordering supplies and equipment for the study.

15) Recruit patients for clinical trials based on criteria outlined in the study protocol.

16) Develop study e-source documents to comply with study protocol.

17) Manage all required study startup documentation, training, and timelines on assigned study protocols.

18) 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) Completion of accredited healthcare certification program, required.

2) 2 years experience in running research protocols, required.

3) 2 years experience in FDA regulations and GCP, required.

4) 2 years experience in phlebotomy and EKG, required.

5) Exceptional attention to details and organization.

6) Must possess excellent verbal and written communication skills.

7) Excellent customer service skills with internal and external stakeholders.

8) A proven ability to multi-task in a rapidly changing environment.