* Senior Clinical Research Associate - PPD Outsourcing Solutions Group *
*Home-Based/Remote Based Contract/Temp Opportunity
*Full Time (FTE 1.0)
*6+ month duration
* The PPD flexible staffing program, with our internal PPD Outsourcing Solutions Group (OSG) offers flexible work options where you can be a part of the PPD culture as a contract, temporary worker, consultant worker or freelancer. *
* *Register today to hear more about open or future opportunities at PPD!* *
The Senior Clinical Researcher (Contract/Temp Opportunity) will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Will conduct site visits to assess protocol and regulatory compliance and manages required documentation. Will ensure that data will pass international quality assurance audits. Will represent PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects. Generally required to travel 60-80% but more for some individuals.
* Essential Functions: *
* Will monitor investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification). Assess investigational product through physical inventory and records review. Document observations in reports and letters in a timely manner using approved business writing standards. Escalate observed deficiencies and issues to clinical management expeditiously, proposes solutions and follow all issues through to resolution. Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
* Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
* Participate in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
* Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc ).
* Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
* Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
* Respond to company, client and federal regulatory requirements/audits.
* Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner.
* Education and Experience: *
* Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor) or equivalent combination of education, training, & experience.
* Valid driver's license where applicable.
*Knowledge, Skills and Abilities: *
* Effective clinical monitoring skills;
* Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
* Excellent understanding and demonstrated application of GCPs and applicable SOPs
* Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
* Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
* Effective interpersonal skills
* Strong attention to detail
* Effective organizational and time management skills
* Ability to remain flexible and adaptable in a wide range of scenarios
* Ability to work in a team or independently as required
* Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
* Good English language and grammar skills
* Good presentation skills
* Physical Demands: *
* Ability to work in an upright and /or stationary position for 6-8 hours per day.
* Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
* Frequent mobility required.
* Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
* Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
* Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
* Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
* Frequently interacts with others to obtain or relate information to diverse groups.
* Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
* Regular and consistent attendance.