We are currently looking for a Senior Clinical Research Associates – Large CRO for Remote or Little Falls, NJ
Please see Job description below:
Title: Senior Clinical Research Associates
Location: Remote / Little Falls, NJ
Type: Permanent - Full Time
Notes: No Corp to Corp | Remote
The incumbent will monitors, reports, tracks study progress, and assesses compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures (SOPs). The role may include leadership of the Clinical Operations study team as well as assessment and direction of other Clinical Operations staff assigned to studies.
1. Interact with personnel from study sponsors, investigational sites, vendors, and cross functional groups to enable timely and high quality initiations and completions of clinical trials.
2. Identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.
3. Compile documentation for qualification of clinical sites. Review that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
4. Assist with preparation and submission of regulatory documents to responsible authorities and IRB/ECs.
5. Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in Trial Master Files. These files must be maintained in a fashion so that they are continuously available for audit and completion for archive.
6. Contribute to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include Monitoring Plans, Risk Management Plans, study guides or manuals, and information collection tools.
7. Develop and review documentation of information provided to study subjects, including informed consent forms.
8. Assist with the preparation and negotiation of contracts with vendors and investigational sites.
9. Participate in and prepare presentations for clinical trial initiation meetings such as investigator meetings or site monitor/coordinator training sessions. Address questions/concerns relevant to Clinical Operations from the meeting participants. Train Clinical Research Associates and site personnel on study requirements and procedures.
10. Perform on-site monitoring of clinical studies.
11. Document monitoring activities through submission of monitoring reports to Clinical Operations management for review, and through correspondence and telephone contact with investigative sites.
12. Responsible for site management. Communicate directly with sites to provide direction, to assess performance, and to propose interventions to enhance enrollment performance.
13. Monitor and report progress/status of investigational sites.
14. Assist with investigator payments.
15. Provide timely and accurate reports of travel expenses.
16. Assist in the preparation, planning, and presentation of bid defenses.
17. Participate in the development and maintenance of, and adhere to departmental SOPs and guidelines.
18. Prepare, maintain, and complete training on study-specific and (or) applicable sponsor SOPs.
19. Support sites in their efforts to prepare for audits conducted either by sponsors or regulatory authorities.
20. Plan and carry out professional development.
Qualifications and Experience:
1. Bachelor's degree in a life science or related field of study.
2. Five years field monitoring clinical trials.
3. Thorough knowledge of GCPs.
4. Thorough comprehension of medical terminology.
5. Excellent command of verbal and written English.
6. Fluency in French is preferred for applicants interested in the Toronto and Quebec locations.
7. Ability to travel a maximum of 70% of working hours is required.